A Phase 2/3 interventional study of Edivoxetine in Attention Deficit Hyperactivity Disorder, sponsored by Eli Lilly and Company. Terminated at 19 sites in 4 countries. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2019-10-08.
Sponsored by Eli Lilly and Company · Phase 2/3, Interventional, and Treatment
The primary purpose of the study is to assess long-term safety and tolerability of Edivoxetine in pediatric participants with attention deficit hyperactive disorder (ADHD).
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-Participants must meet Diagnostic and Statistical Manual of Mental Disorders 4th Ed (DSM-IV) diagnostic criteria for ADHD (inattentive, hyperactive/impulsive, or combined subtypes) based on an interview by an experienced clinician and confirmed using the Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present (SADS) and Lifetime Version (K-SADS-PL) at Visit 1 for new participants and in the parent trial for rollover participants.
-Participants must have an ADHDRS-IV-Parent: Inv total score of at least 1.5 standard deviations above the age/gender norm at both screening/randomization. New participants must have a Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder- Severity (CGI-ADHD-S) score greater than or equal to 4 at both screening/randomization.
EXCLUSION CRITERIA:
All enrolled participants were administered starting dose of 0.1 milligram per kilogram per day (mg/kg/day), or participant specific known stable dose, rollover participants (LNBJ \[No NCT number\]) and (LNBF \[NCT00922636\]), up to 0.3 mg/kg/day, oral, daily for up to 5 years.
Drug: Edivoxetine
0.1 mg/kg/day or participant specific known stable dose, rollover participants (LNBJ \[No NCT number\]) and (LNBF \[NCT00922636\]), up to 0.3 mg/kg/day, oral, daily for up to 5 years.
Also known as: LY2216684
Percentage of Participants With At Least One Serious Adverse Events (SAE) Over the Duration of the Study
Percentage of Participants experienced at least one SAE during the study. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Time frame: Baseline Through Week 252
Number of Participants With At Least One SAE
Number of Participants experienced at least one SAE during the study. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Time frame: Baseline Through Week 252
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Percentage of Participants had at least one TEAE during the study. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Time frame: Baseline Through Week 252
Number of Participants With At Least One TEAE
Number of participants had at least one TEAE during the study. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Time frame: Baseline Through Week 252
Percentage of Participants With Discontinuation Due to Adverse Events (DCAEs)
Time frame: Baseline Through Week 252
Number of Participants With At Least One DCAEs
Time frame: Baseline Through Week 252
Percentage of Participants Who Discontinued Due to Any Reason
Time frame: Baseline Through Week 252
Number of Participants Who Discontinued Due to Any Reason
Time frame: Baseline Through Week 252
Percentage of Participants With Columbia-Suicide Severity Rating Scale (CSSRS) for Each Category
Percentage of Participants in each category of CSSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. Participants with suicidal ideation were those who had yes to any of the following questions: Wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intent to act, active suicidal ideation with some intent to act, without specific plan, and active suicidal ideation with specific plan and intent. Suicidal behavior included those who had yes to any of the following questions: Preparatory acts or behavior, Aborted attempt, Interrupted attempt, Non-fatal suicide attempt, Completed suicide.
Time frame: Baseline Through Week 252, Baseline, 1-month (mo) Follow-Up (f/u)
Mean Change From Baseline Z-scores for Height
A z-score is the number of standard deviations a data point is from the mean. Z-scores range from -3 standard deviations (far left of the mean in normal distribution curve) up to +3 standard deviations (far right of the mean in normal distribution curve).
Time frame: Baseline, Week 60; Baseline, Week 240
Mean Change From Baseline Z-Score for Weight
A z-score is the number of standard deviations a data point is from the mean. Z-scores range from -3 standard deviations (far left of the mean in normal distribution curve) up to +3 standard deviations (far right of the mean in normal distribution curve).
Time frame: Baseline, Week 60; Baseline, Week 240
Mean Change From Baseline Z-Score in Body Mass Index (BMI)
Time frame: Baseline, Week 60; Baseline, Week 240
Percentage of Participants With Response Rates
Time frame: Week 12
Number of Participants With a Response Rate
Time frame: Week 12
Survival Curve Time to Response
Time frame: Week 12
Percentage of Participants in Sexual Maturation on Tanners Scale
Participant's stage of sexual maturation were assessed using the Tanner staging measure for determining pubertal development in male and female participants. Tanner staging includes a self-assessment of pubic hair development (both males and females), genital development (males), and breast development (females). Tanner stage (pubic) is a score of range 1-5 where 1=no development and 5=adult pubic hair. Tanner stage (breast) is a score of range 1-5 where 1=no development and 5=adult breast. Tanner stages (1-5) were used to characterize physical development in children, adolescents, and adults. The stages were based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger.
Time frame: Baseline Up to Week 252
Number of Participants in Sexual Maturation on Tanners Scale
Participant's stage of sexual maturation were assessed using the Tanner staging measure for determining pubertal development in male and female participants. Tanner staging includes a self-assessment of pubic hair development (both males and females), genital development (males), and breast development (females). Tanner stage (pubic) is a score of range 1-5 where 1=no development and 5=adult pubic hair. Tanner stage (breast) is a score of range 1-5 where 1=no development and 5=adult breast. Tanner stages (1-5) were used to characterize physical development in children, adolescents, and adults. The stages were based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger.
Time frame: Baseline Up to Week 252
Percentage of Participants With Tobacco, Alcohol and Marijuana Use
Time frame: Week 60 through Week 252
Number of Participants With Tobacco, Alcohol and Marijuana Use
Time frame: Week 60 through Week 252
Mean Change From Baseline of Each Score Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) (Hyperactive/Impulsive, Inattentive and Total Score)
The ADHDRS-IV-Parent scale measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total score is computed as the sum of the 18 items and ranges from 0 to 54. Inattention and Hyperactivity-Impulsivity subscales consisted of 9 items each, for total subscale scores ranging from 0 to 27. Higher total and subscale scores are indicative of more severe symptoms. Least-squares (LS) mean change from baseline was adjusted for repeated measure analysis included baseline score and visit time in the model.
Time frame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252
Mean Change From Baseline of Total Score Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity (CGI-ADHD-S)
The CGI-ADHD-S measures severity of the participants overall severity of ADHD symptoms. The score ranges from 1 to 7 (1=normal, not at all ill; 7=among the most extremely ill participants). LS mean change from baseline was adjusted for repeated measure analysis included baseline score and visit time in the model.
Time frame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252
Mean Change of Total Score Teacher-rated Swanson Nolan, and Pelham Rating Scale-Revised (SNAP-IV) ADHD Subscales (Hyperactive/Impulsive, Inattentive and Total Score)
The SNAP-IV is a revision of the Swanson, Nolan, and Pelham (SNAP) Questionnaire (Swanson et al 1983). The SNAP-IV: ADHD Inattention Subscale (items 1-9) scores the intensity of each item during the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). Possible scores range from 0-27. Lower scores indicate a lesser intensity of inattention and higher scores a greater intensity. The SNAP-IV ADHD Hyperactivity/Impulsivity Subscale (items 10-18) scores the intensity of each item in the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). Possible scores range from 0-27. Lower scores indicate a lesser intensity of hyperactivity/impulsivity and higher scores, a greater intensity. SNAP-IV ADHD Combined Scale score (inattention + hyperactivity/impulsivity) ranges from 0-54. A low score of 0 indicates less inattention + hyperactivity/impulsivity. A high score of 54 indicates more inattention + hyperactivity.
Time frame: Baseline, Week 12
Mean Change From Baseline of Total Score SNAP-IV Oppositional Defiant Disorder (ODD) Subscale
The SNAP-IV ODD subscale includes items #21 to #28. Each item is scored on a 0 to 3 scale (0 = "Not At All", 1 = "Just A Little", 2 = "Pretty Much", 3 = "Very Much"). Score ranges from 0-24. The lowest possible score is 0; highest is 24. Higher scores indicate a greater presence of ODD and lowers scores a lower presence of ODD.
Time frame: Baseline, Week 12
Mean Change From Baseline of Each Total Score Conners Comprehensive Behavior Rating Scales (CP-CBRS) Diagnostic and Statistical Manual of Mental Disorders, 4th Ed, Text Revision (DSM-IV-TR) for Symptom Subscales Manic Episode and Mixed Episode
The Conners CBRS measures behaviors, emotions, and academic problems in children and adolescents. DSM-IV-TR symptom scales is included and assesses the following disorders: ADHD, conduct disorder, ODD, major depressive episode, manic episode, mixed episode, generalized anxiety disorder, separation anxiety disorder, social phobia, obsessive compulsive disorder, autistic disorder, and Asperger's disorder. The age range suitable for this assessment is 6 to 18 years of age for parent form (203-item) and the teacher form (204-item) and 8 to18 years of age for the self-report form (179-item). The 203-item parent form of CP-CBRS was used in this study and completed by the parents/primary caregivers of the participants. Total score for each subscale is expressed as T-score based on gender/age norms: T-scores range from 0-100. Higher score indicates higher severity. Lower score indicate lower severity.
Time frame: Baseline, Week 60; Baseline, Week 252
Mean Change From Baseline of Each Total Score CP-CBRS (DSM-IV-TR) ADHD Symptom Subscales (Hyperactive/Impulsive and Inattentive)
The Conners CBRS measures behaviors, emotions, and academic problems in children and adolescents. DSM-IV-TR symptom scales is included and assesses the following disorders: ADHD, conduct disorder, ODD, major depressive episode, manic episode, mixed episode, generalized anxiety disorder, separation anxiety disorder, social phobia, obsessive compulsive disorder, autistic disorder, and Asperger's disorder. The age range suitable for this assessment is 6 to 18 years of age for parent form (203-item) and the teacher form (204-item) and 8 to18 years of age for the self-report form (179-item). The 203-item parent form of CP-CBRS was used in this study and completed by the parents/primary caregivers of the participants. Total score for each subscale is expressed as T-score based on gender/age norms: T-scores range from 0-100. Higher score indicates higher severity. Lower score indicate lower severity.
Time frame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252
Mean Change From Baseline of Each Total Score CP-CBRS DSM-IV-TR for Oppositional Defiant Disorder (ODD), Anxiety, Conduct Disorder and Major Depressive Episode
The Conners CBRS measures behaviors, emotions, and academic problems in children and adolescents. DSM-IV-TR symptom scales is included and assesses the following disorders: ADHD, conduct disorder, ODD, major depressive episode, manic episode, mixed episode, generalized anxiety disorder, separation anxiety disorder, social phobia, obsessive compulsive disorder, autistic disorder, and Asperger's disorder. The age range suitable for this assessment is 6 to 18 years of age for parent form (203-item) and the teacher form (204-item) and 8 to18 years of age for the self-report form (179-item). The 203-item parent form of CP-CBRS was used in this study and completed by the parents/primary caregivers of the participants. Total score for each subscale is expressed as T-score based on gender/age norms: T-scores range from 0-100. Higher score indicates higher severity. Lower score indicate lower severity.
Time frame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252
Mean Change From Baseline of Each Raw Score CP-CBRS Impairment Items Subscales for Schoolwork/Grades, Friendship/Relationships, and Home Life
The Conners CBRS measures behaviors, emotions, and academic problems in children and adolescents. DSM-IV-TR symptom scales is included and assesses the following disorders: ADHD, conduct disorder, ODD, major depressive episode, manic episode, mixed episode, generalized anxiety disorder, separation anxiety disorder, social phobia, obsessive compulsive disorder, autistic disorder, and Asperger's disorder. The age range suitable for this assessment is 6 to 18 years of age for parent form (203-item) and the teacher form (204-item) and 8 to18 years of age for the self-report form (179-item). The 203-item parent form of CP-CBRS was used in this study and completed by the parents/primary caregivers of the participants. Schoolwork/grades, friendships/relationships, home life functioning scores range from 0=never to 3=very often. Raw scores are presented for each subscale with higher scores indicating higher severity and lower scores indicating lower severity.
Time frame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252
Mean Change From Baseline of Each Total Score CP-CBRS Content Subscale for Aggressive Behaviors, Academic Difficulties, Social Problems, and Violence Potential)
CP-CBRS is a comprehensive assessment of a wide spectrum of behaviors, emotions, and academic problems in children and adolescents. It includes DSM-IV-TR symptom scales, empirical and rational scales, other clinical indicators and critical and impairment items. DSM-IV-TR symptom scales assess ADHD, conduct disorder, ODD, major depressive episode, manic episode, mixed episode, generalized anxiety disorder, separation anxiety disorder, social phobia, obsessive compulsive disorder, autistic disorder, and Asperger's disorder. The age range is 6 to 18 years of age for parent form (203-item) and the teacher form (204-item) and 8 to18 years of age self-report form (179-item). The parent form of Conners CBRS (CP-CBRS) was used in this study and completed by the parents/primary caregivers of the participants. Total score for each subscale is expressed as T-score based on gender/age norms: T-scores range from 0-100. Higher score indicates higher severity. Lower score indicate lower severity
Time frame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252
Mean Change From Baseline of the 5 Domain Scores Child Health and Illness Profile-Adolescent Edition (CHIP-AE) in 5 Health Outcome Domains (Satisfaction, Comfort, Resilience, Risk Avoidance and Achievement)
CHIP-AE Child Report Form (CRF) is an adolescent rated assessment of their health status and level of functioning. The items in the 5 domains include: Achievement, Satisfaction, Comfort, Risk Avoidance, and Resilience. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.
Time frame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 156
Mean Change From Baseline of the 5 Domain Scores Child Health and Illness Profile-Child Edition (CHIP-CE) in 5 Health Outcome Domains (Satisfaction, Comfort, Resilience, Risk Avoidance and Achievement)
CHIP-CE Parent Report Form (PRF) is a parent rated assessment of a child's health status/level of functioning. The achievement domain describes developmentally appropriate role functioning in school and with peers. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.
Time frame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 156
Mean Change From Baseline of Total Score Euro-Qol Questionnaire - 5 Dimensions 3 Levels (EQ-5D-3L) Health State for Parent
The EQ-5D-3L is a generic, multidimensional, health-related, quality-of-life (QoL) instrument that contains 2 parts: a health status profile and a visual analog scale to rate global health-related QoL. The profile allows respondents to rate their health state in 5 health dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels of measure: no problems, some problems, and severe problems. The 5 dimensions of the health state profile are reported as a population-based (UK or US) health index score of theoretically possible health states ranging from 0-1; where 0 is death and 1 is perfect health. i.e., higher is better. Parents of the participants completed the EQ-5D-3L form for rating their own quality of life.
Time frame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252
Mean Change From Baseline of Total Score EQ-5D-3L Visual Analog Scale (VAS) for Parent
The EQ-5D-3L is a generic, multidimensional, health-related, QoL instrument that contains 2 parts: a health status profile and a visual analog scale to rate global health-related QoL. The visual analog scale reported records the respondent's self-rated health state on a vertical line where the endpoints are labeled 100 being "best imaginable health state" and 0 being "worst imaginable health state." Parents of the participants complete EQ-5D-3L form for rating their own health.
Time frame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252
Mean Change of From Baseline Total Score EQ-5D-3L Health State for Child
The EQ-5D-3L is a generic, multidimensional, health-related, QoL instrument that contains 2 parts: a health status profile and a visual analog scale to rate global health-related QoL. The profile allows respondents to rate their health state in 5 health dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels of measure: no problems, some problems, and severe problems. The 5 dimensions of the health state profile are reported as a population-based (UK or US) health index score of theoretically possible health states ranging from 0-1; where 0 is death and 1 is perfect health. Parents of the participants aged 6 to 11 years completed the EQ-5D-3L form regarding the participants health-related quality of life. i.e., young children were unable to assess their own quality of life so the parents assessed the child's quality of life for them.
Time frame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252
Mean Change of From Baseline Total Score EQ-5D-3L VAS for Child
EQ-5D-3L is a generic, multidimensional, health-related, QoL instrument that contains 2 parts: a health status profile and a visual analog scale to rate global health-related QoL. The visual analog scale reported records the respondent's self-rated health state on a vertical line where the endpoints are labeled 100 being "best imaginable health state" and 0 being "worst imaginable health state." Parents of the participants aged 6 to 11 years complete the EQ-5D-3L form for rating the participants health-related QoL, EQ-5D-3L. i.e., the young child was unable to assess their own quality of life then the parent assessed the child's quality of life.
Time frame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252
Mean Change From Baseline of Total Score EQ-5D-3L Health State for Adolescent
EQ-5D-3L is a generic, multidimensional, health-related, QoL instrument that contains 2 parts: a health status profile and a visual analog scale to rate global health-related QoL. The profile allows respondents to rate their health state in 5 health dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels of measure: no problems, some problems, and severe problems. The 5 dimensions of the health state profile are reported as a population-based (UK or US) health index score of theoretically possible health states ranging from 0-1; where 0 is death and 1 is perfect health. i.e., higher is better. Participants aged 12 years or older rate their own health-related quality of life using EQ-5D-3L.
Time frame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252
Mean Change From Baseline of Total Score EQ-5D-3L VAS
EQ-5D-3L is a generic, multidimensional, health-related, QoL instrument that contains 2 parts: a health status profile and a visual analog scale to rate global health-related QoL. The visual analog scale reported records the respondent's self-rated health state on a vertical line where the endpoints are labeled 100 being "best imaginable health state" and 0 or being "worst imaginable health state." Participants aged 12 years or older rated their own health-related quality of life using the EQ-5D-3L VAS scale.
Time frame: Baseline, Week 12; Baseline, Week 60; Baseline, Week 252
Mean Change From Baseline of Total Score Woodcock Johnson III Test of Achievement ([WJ III ACH])
The Woodcock Johnson (WJ III ACH) (Woodcock 2001) is designed to measure academic achievement and evaluates a person aged 2 to 90 years and the tool takes 60 to 160 minutes to complete depending on a person's academic level. The WJ III ACH has 2 parallel forms (A and B) that can be administered in an alternating fashion. The WCJ III ACH uses standard scores (Deviation IQ) with an average standard score of 100 and a standard deviation of 15. Higher scores indicate better abilities/achievements. Lower scores indicate worse abilities/achievements.
Time frame: Baseline, Week 60
Mean Change From Baseline of Total Score Wide Range Achievement Test (WRAT 4)
The WRAT 4 is a norm-referenced test that measures the basic academic skills of word reading, sentence comprehension, spelling, and math computation. There are 2 alternate forms (Blue Form, Green Form) that can be used interchangeably with comparable results. It can be used to evaluate a person aged 5 to 94 years and the administration time is 30 to 45 minutes for children (8 years or older) and adults, and 15 to 25 minutes for young children (ages 5 to 7 years). The age-normed standard scores range from 55 - 145 and for each subtest/composite includes word reading, sentence comprehension, spelling, math computation and reading composite. Higher scores indicate better abilities/achievements. Lower scores indicate worse abilities/achievements.
Time frame: Baseline, Week 60
Mean Change From Baseline of Total Score Wechsler Intelligence Scale for Children Fourth Edition (WISC-IV)
The fourth edition of the WISC assessment (WISC-IV®) is administered to children ranging from 6 years to 16 years, 11 months. It contains 10 core subtests and 5 supplementary subtests, and takes 65-80 minutes to complete. In this study, Digit Span and Letter-Number Sequencing subtests were completed. Scaled scores range from 1 to 19. Higher scores denote better performance. Lower scores denote worse performance.
Time frame: Baseline, Week 60
Mean Change From Baseline of Total Score Wechsler Adult Intelligence Scale - Third Edition (WAIS-III)
The WAIS-III® was used in the participants aged 17 years or older. Comprehensive reporting on the participant's intellectual ability is not required in this study. Raw scores for each of the 14 subtests are reported. Raw score ranges for each subtest are as follows: picture completion (0-25), vocabulary (0-66), digit symbol coding (0-133), similarities (0-33), block design (0-68), arithmetic (0-22), matrix reasoning (0-26), digit span forward and backward total (0-30), information (0-28), picture arrangement (0-22), comprehension (0-33), symbol search (0-60), letter-number sequencing (0-21), and object assembly (0-52). Higher scores reflect better performance and lower scores reflect lower performance.
Time frame: Baseline, Week 60
| Milestone | Edivoxetine |
|---|---|
| Started | 267 |
| Not lost to f/u at first post-baseline | 264 |
| Completed | 20 |
| Not completed | 247 |
| Withdrew: Adverse event | 33 |
| Withdrew: Entry criteria not met | 1 |
| Withdrew: Protocol violation | 21 |
| Withdrew: Withdrawal by subject | 27 |
| Withdrew: Physician decision | 6 |
| Withdrew: Sponsor decision | 5 |
| Withdrew: Parent/caregiver decision | 41 |
| Withdrew: Lack of efficacy | 67 |
| Withdrew: Lost to follow-up | 46 |
| Milestone | Edivoxetine |
|---|---|
| Started | 80 |
| Completed | 18 |
| Not completed | 62 |
| Withdrew: Adverse event | 9 |
| Withdrew: Protocol violation | 4 |
| Withdrew: Withdrawal by subject | 8 |
| Withdrew: Physician decision | 4 |
| Withdrew: Parent/caregiver decision | 9 |
| Withdrew: Lack of efficacy | 28 |
Percentage of Participants experienced at least one SAE during the study. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
| percentage of participants | Edivoxetine |
|---|---|
| Percentage of Participants With At Least One Serious Adverse Events (SAE) Over the Duration of the Study | 2.65 |
Number of Participants experienced at least one SAE during the study. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
| Participants | Edivoxetine |
|---|---|
| Number of Participants With At Least One SAE | 7 |
Percentage of Participants had at least one TEAE during the study. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
| percentage of participants | Edivoxetine |
|---|---|
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | 76.89 |
Number of participants had at least one TEAE during the study. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
| Participants | Edivoxetine |
|---|---|
| Number of Participants With At Least One TEAE | 203 |
| percentage of participants | Edivoxetine |
|---|---|
| Percentage of Participants With Discontinuation Due to Adverse Events (DCAEs) | 12.50 |
| Participants | Edivoxetine |
|---|---|
| Number of Participants With At Least One DCAEs | 33 |
| Percentage of participants | Edivoxetine |
|---|---|
| Percentage of Participants Who Discontinued Due to Any Reason | 92.51 |
| Participants | Edivoxetine |
|---|---|
| Number of Participants Who Discontinued Due to Any Reason | 247 |
Percentage of Participants in each category of CSSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. Participants with suicidal ideation were those who had yes to any of the following questions: Wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intent to act, active suicidal ideation with some intent to act, without specific plan, and active suicidal ideation with specific plan and intent. Suicidal behavior included those who had yes to any of the following questions: Preparatory acts or behavior, Aborted attempt, Interrupted attempt, Non-fatal suicide attempt, Completed suicide.
| percentage of participants | Edivoxetine |
|---|---|
| 0-5 Years (Suicidal Ideation) | 5.68 |
| 0-5 Years (Suicidal Behavior) | 0.00 |
| 0-5 Yrs (Non-suicidal self-injurious) | 0.38 |
| 1 month f/u (Suicidal Ideation) | 1.27 |
| 1 month f/u (Suicidal Behavior) | 0.00 |
| 1 mo f/u (Non-suicidal self-injurious behavior) | 0.00 |
A z-score is the number of standard deviations a data point is from the mean. Z-scores range from -3 standard deviations (far left of the mean in normal distribution curve) up to +3 standard deviations (far right of the mean in normal distribution curve).
| Z-Score | Edivoxetine |
|---|---|
| Week 60 | -0.05 ± 0.36 |
| Week 240 | -0.11 ± 0.53 |
A z-score is the number of standard deviations a data point is from the mean. Z-scores range from -3 standard deviations (far left of the mean in normal distribution curve) up to +3 standard deviations (far right of the mean in normal distribution curve).
| Z-Score | Edivoxetine |
|---|---|
| Week 60 | -0.17 ± 0.37 |
| Week 240 | -0.25 ± 0.77 |
| Z-Score | Edivoxetine |
|---|---|
| Week 60 | -0.20 ± 0.40 |
| Week 240 | -0.32 ± 0.83 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Participant's stage of sexual maturation were assessed using the Tanner staging measure for determining pubertal development in male and female participants. Tanner staging includes a self-assessment of pubic hair development (both males and females), genital development (males), and breast development (females). Tanner stage (pubic) is a score of range 1-5 where 1=no development and 5=adult pubic hair. Tanner stage (breast) is a score of range 1-5 where 1=no development and 5=adult breast. Tanner stages (1-5) were used to characterize physical development in children, adolescents, and adults. The stages were based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger.
| percentage of participants | Edivoxetine |
|---|---|
| Pubic Hair Male Tanner I | 25.00 |
| Pubic Hair Male Tanner II | 11.00 |
| Pubic Hair Male Tanner III | 10.00 |
| Pubic Hair Male Tanner IV | 23.00 |
| Pubic Hair Male Tanner V | 31.00 |
| Pubic Hair Female Tanner I | 12.50 |
| Pubic Hair Female Tanner II | 14.58 |
| Pubic Hair Female Tanner III | 6.25 |
| Pubic Hair Female Tanner IV | 20.83 |
| Pubic Hair Female Tanner V | 45.83 |
| Genital Development Male Tanner I | 22.00 |
| Genital Development Male Tanner II | 11.00 |
| Genital Development Male Tanner III | 18.00 |
| Genital Development Male Tanner IV | 17.00 |
| Genital Development Male Tanner V | 32.00 |
| Breast Development Female Tanner I | 16.67 |
| Breast Development Female Tanner II | 6.25 |
| Breast Development Female Tanner III | 16.67 |
| Breast Development Female Tanner IV | 22.92 |
| Breast Development Female Tanner V | 37.50 |
Participant's stage of sexual maturation were assessed using the Tanner staging measure for determining pubertal development in male and female participants. Tanner staging includes a self-assessment of pubic hair development (both males and females), genital development (males), and breast development (females). Tanner stage (pubic) is a score of range 1-5 where 1=no development and 5=adult pubic hair. Tanner stage (breast) is a score of range 1-5 where 1=no development and 5=adult breast. Tanner stages (1-5) were used to characterize physical development in children, adolescents, and adults. The stages were based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger.
| Participants | Edivoxetine |
|---|---|
| Pubic Hair Male Tanner I | 25 |
| Pubic Hair Male Tanner II | 11 |
| Pubic Hair Male Tanner III | 10 |
| Pubic Hair Male Tanner IV | 23 |
| Pubic Hair Male Tanner V | 31 |
| Pubic Hair Female Tanner I | 6 |
| Pubic Hair Female Tanner II | 7 |
| Pubic Hair Female Tanner III | 3 |
| Pubic Hair Female Tanner IV | 10 |
| Pubic Hair Female Tanner V | 22 |
| Genital Development Male Tanner I | 22 |
| Genital Development Male Tanner II | 11 |
| Genital Development Male Tanner III | 18 |
| Genital Development Male Tanner IV | 17 |
| Genital Development Male Tanner V | 32 |
| Breast Development Female Tanner I | 8 |
| Breast Development Female Tanner II | 3 |
| Breast Development Female Tanner III | 8 |
| Breast Development Female Tanner IV | 11 |
| Breast Development Female Tanner V | 18 |
| percentage of participants | Edivoxetine |
|---|---|
| Current Tobacco Use Week 60 | 0 |
| Current Alcohol Use Week 60 | 0 |
| Current Marijuana Use Week 60 | 0 |
| Current Tobacco Use Week 252 | 0 |
| Current Alcohol Use Week 252 | 0 |
| Current Marijuana Use Week 252 | 0 |
| Participants | Edivoxetine |
|---|---|
| Current Tobacco Use Week 60 | 0 |
| Current Alcohol Use Week 60 | 0 |
| Current Marijuana Use Week 60 | 0 |
| Current Tobacco Use Week 252 | 0 |
| Current Alcohol Use 252 | 0 |
| Current Marijuana Use Week 252 | 0 |
The ADHDRS-IV-Parent scale measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total score is computed as the sum of the 18 items and ranges from 0 to 54. Inattention and Hyperactivity-Impulsivity subscales consisted of 9 items each, for total subscale scores ranging from 0 to 27. Higher total and subscale scores are indicative of more severe symptoms. Least-squares (LS) mean change from baseline was adjusted for repeated measure analysis included baseline score and visit time in the model.
| units on a scale | Edivoxetine |
|---|---|
| Hyperactivity Impulsivity subscale Week 12 | -3.45 ± 0.33 |
| Hyperactivity Impulsivity subscale Week 60 | -4.27 ± 0.38 |
| Hyperactivity Impulsivity subscale Week 252 | -7.48 ± 0.46 |
| Inattention Score Week 12 | -3.91 ± 0.38 |
| Inattention Score Week 60 | -3.69 ± 0.45 |
| Inattention Score Week 252 | -5.59 ± 0.73 |
| Total Score Week 12 | -7.28 ± 0.65 |
| Total Score Week 60 | -7.83 ± 0.76 |
| Total Score Week 252 | -12.82 ± 1.06 |
The CGI-ADHD-S measures severity of the participants overall severity of ADHD symptoms. The score ranges from 1 to 7 (1=normal, not at all ill; 7=among the most extremely ill participants). LS mean change from baseline was adjusted for repeated measure analysis included baseline score and visit time in the model.
| units on a scale | Edivoxetine |
|---|---|
| Week 12 | -0.73 ± 0.07 |
| Week 60 | -0.85 ± 0.10 |
| Week 252 | -0.97 ± 0.17 |
The SNAP-IV is a revision of the Swanson, Nolan, and Pelham (SNAP) Questionnaire (Swanson et al 1983). The SNAP-IV: ADHD Inattention Subscale (items 1-9) scores the intensity of each item during the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). Possible scores range from 0-27. Lower scores indicate a lesser intensity of inattention and higher scores a greater intensity. The SNAP-IV ADHD Hyperactivity/Impulsivity Subscale (items 10-18) scores the intensity of each item in the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). Possible scores range from 0-27. Lower scores indicate a lesser intensity of hyperactivity/impulsivity and higher scores, a greater intensity. SNAP-IV ADHD Combined Scale score (inattention + hyperactivity/impulsivity) ranges from 0-54. A low score of 0 indicates less inattention + hyperactivity/impulsivity. A high score of 54 indicates more inattention + hyperactivity.
| units on a scale | Edivoxetine |
|---|---|
| Inattention Score | 0.04 ± 0.42 |
| Hyperactivity/Impulsivity Score | 0.05 ± 0.38 |
| Total Score | 0.04 ± 0.32 |
The SNAP-IV ODD subscale includes items #21 to #28. Each item is scored on a 0 to 3 scale (0 = "Not At All", 1 = "Just A Little", 2 = "Pretty Much", 3 = "Very Much"). Score ranges from 0-24. The lowest possible score is 0; highest is 24. Higher scores indicate a greater presence of ODD and lowers scores a lower presence of ODD.
| units on a scale | Edivoxetine |
|---|---|
| Mean Change From Baseline of Total Score SNAP-IV Oppositional Defiant Disorder (ODD) Subscale | 0.02 ± 0.23 |
The Conners CBRS measures behaviors, emotions, and academic problems in children and adolescents. DSM-IV-TR symptom scales is included and assesses the following disorders: ADHD, conduct disorder, ODD, major depressive episode, manic episode, mixed episode, generalized anxiety disorder, separation anxiety disorder, social phobia, obsessive compulsive disorder, autistic disorder, and Asperger's disorder. The age range suitable for this assessment is 6 to 18 years of age for parent form (203-item) and the teacher form (204-item) and 8 to18 years of age for the self-report form (179-item). The 203-item parent form of CP-CBRS was used in this study and completed by the parents/primary caregivers of the participants. Total score for each subscale is expressed as T-score based on gender/age norms: T-scores range from 0-100. Higher score indicates higher severity. Lower score indicate lower severity.
| T-score | Edivoxetine |
|---|---|
| Manic Episode Week 60 | -7.09 ± 16.05 |
| Manic Episode Week 252 | -14.85 ± 16.04 |
The Conners CBRS measures behaviors, emotions, and academic problems in children and adolescents. DSM-IV-TR symptom scales is included and assesses the following disorders: ADHD, conduct disorder, ODD, major depressive episode, manic episode, mixed episode, generalized anxiety disorder, separation anxiety disorder, social phobia, obsessive compulsive disorder, autistic disorder, and Asperger's disorder. The age range suitable for this assessment is 6 to 18 years of age for parent form (203-item) and the teacher form (204-item) and 8 to18 years of age for the self-report form (179-item). The 203-item parent form of CP-CBRS was used in this study and completed by the parents/primary caregivers of the participants. Total score for each subscale is expressed as T-score based on gender/age norms: T-scores range from 0-100. Higher score indicates higher severity. Lower score indicate lower severity.
| T Score | Edivoxetine |
|---|---|
| Inattentive Week 12 | -5.66 ± 13.44 |
| Inattentive Week 60 | -8.29 ± 14.59 |
| Inattentive Week 252 | -12.20 ± 13.32 |
| Hyperactivity/Impulsivity Week 12 | -6.33 ± 13.44 |
| Hyperactivity/Impulsivity Week 60 | -7.56 ± 14.65 |
| Hyperactivity/Impulsivity Week 252 | -13.80 ± 15.66 |
The Conners CBRS measures behaviors, emotions, and academic problems in children and adolescents. DSM-IV-TR symptom scales is included and assesses the following disorders: ADHD, conduct disorder, ODD, major depressive episode, manic episode, mixed episode, generalized anxiety disorder, separation anxiety disorder, social phobia, obsessive compulsive disorder, autistic disorder, and Asperger's disorder. The age range suitable for this assessment is 6 to 18 years of age for parent form (203-item) and the teacher form (204-item) and 8 to18 years of age for the self-report form (179-item). The 203-item parent form of CP-CBRS was used in this study and completed by the parents/primary caregivers of the participants. Total score for each subscale is expressed as T-score based on gender/age norms: T-scores range from 0-100. Higher score indicates higher severity. Lower score indicate lower severity.
| T-score | Edivoxetine |
|---|---|
| ODD Week 12 | -1.77 ± 11.17 |
| ODD Week 60 | -1.65 ± 15.03 |
| ODD Week 252 | -5.15 ± 9.41 |
| Anxiety Week 12 | -3.36 ± 11.84 |
| Anxiety Week 60 | -4.00 ± 15.71 |
| Anxiety Week 252 | -12.00 ± 12.03 |
| Conduct Disorder Week 12 | -2.12 ± 11.95 |
| Conduct Disorder Week 60 | -1.97 ± 14.35 |
| Conduct Disorder Week 252 | -2.65 ± 7.52 |
| Major Depressive Episode Week 12 | -3.31 ± 12.12 |
| Major Depressive Episode Week 60 | -3.43 ± 14.72 |
| Major Depressive Episode Week 252 | -9.05 ± 10.64 |
The Conners CBRS measures behaviors, emotions, and academic problems in children and adolescents. DSM-IV-TR symptom scales is included and assesses the following disorders: ADHD, conduct disorder, ODD, major depressive episode, manic episode, mixed episode, generalized anxiety disorder, separation anxiety disorder, social phobia, obsessive compulsive disorder, autistic disorder, and Asperger's disorder. The age range suitable for this assessment is 6 to 18 years of age for parent form (203-item) and the teacher form (204-item) and 8 to18 years of age for the self-report form (179-item). The 203-item parent form of CP-CBRS was used in this study and completed by the parents/primary caregivers of the participants. Schoolwork/grades, friendships/relationships, home life functioning scores range from 0=never to 3=very often. Raw scores are presented for each subscale with higher scores indicating higher severity and lower scores indicating lower severity.
| units on a scale | Edivoxetine |
|---|---|
| Schoolwork or Grades Week 12 | -0.35 ± 1.10 |
| Schoolwork or Grades Week 60 | -0.48 ± 1.17 |
| Schoolwork or Grades Week 252 | -0.65 ± 1.04 |
| Friendships and relationships Week 12 | -0.23 ± 0.91 |
| Friendships and relationships Week 60 | -0.26 ± 1.07 |
| Friendships and relationships Week 252 | -0.70 ± 0.98 |
| Home Life Week 12 | -0.30 ± 1.02 |
| Home Life Week 60 | -0.48 ± 1.12 |
| Home Life Week 252 | -0.80 ± 0.89 |
CP-CBRS is a comprehensive assessment of a wide spectrum of behaviors, emotions, and academic problems in children and adolescents. It includes DSM-IV-TR symptom scales, empirical and rational scales, other clinical indicators and critical and impairment items. DSM-IV-TR symptom scales assess ADHD, conduct disorder, ODD, major depressive episode, manic episode, mixed episode, generalized anxiety disorder, separation anxiety disorder, social phobia, obsessive compulsive disorder, autistic disorder, and Asperger's disorder. The age range is 6 to 18 years of age for parent form (203-item) and the teacher form (204-item) and 8 to18 years of age self-report form (179-item). The parent form of Conners CBRS (CP-CBRS) was used in this study and completed by the parents/primary caregivers of the participants. Total score for each subscale is expressed as T-score based on gender/age norms: T-scores range from 0-100. Higher score indicates higher severity. Lower score indicate lower severity
| T-score | Edivoxetine |
|---|---|
| Aggressive behaviors Week 12 | -1.53 ± 11.85 |
| Aggressive behaviors Week 60 | -0.80 ± 14.31 |
| Aggressive behaviors Week 252 | -5.65 ± 7.84 |
| Academic difficulties Week 12 | -4.39 ± 10.73 |
| Academic difficulties Week 60 | -4.37 ± 12.83 |
| Academic difficulties Week 252 | -8.55 ± 14.39 |
| Social problems Week 12 | -0.37 ± 12.21 |
| Social problems Week 60 | -1.12 ± 13.25 |
| Social problems Week 252 | -4.65 ± 13.83 |
| Violence Potential Week 12 | -1.25 ± 9.55 |
| Violence Potential Week 60 | -0.79 ± 10.72 |
| Violence Potential Week 252 | -3.70 ± 3.73 |
CHIP-AE Child Report Form (CRF) is an adolescent rated assessment of their health status and level of functioning. The items in the 5 domains include: Achievement, Satisfaction, Comfort, Risk Avoidance, and Resilience. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.
| T-score | Edivoxetine |
|---|---|
| Satisfaction Week 12 | 1.81 ± 6.86 |
| Satisfaction Week 60 | 1.01 ± 7.62 |
| Satisfaction Week 156 | 3.29 ± 5.52 |
| Discomfort Week 12 | 1.89 ± 4.88 |
| Discomfort Week 60 | 0.07 ± 5.65 |
| Discomfort Week 156 | 1.35 ± 7.29 |
| Resilience Week 12 | -1.20 ± 8.85 |
| Resilience Week 60 | -0.00 ± 8.69 |
| Resilience Week 156 | 0.95 ± 8.26 |
| Risk Avoidance Week 12 | 1.49 ± 6.26 |
| Risk Avoidance Week 60 | -2.04 ± 6.17 |
| Risk Avoidance Week 156 | -3.27 ± 5.81 |
| Achievement Week 12 | 0.70 ± 5.86 |
| Achievement Week 60 | -2.35 ± 8.40 |
| Achievement Week 156 | 7.33 ± NA |
CHIP-CE Parent Report Form (PRF) is a parent rated assessment of a child's health status/level of functioning. The achievement domain describes developmentally appropriate role functioning in school and with peers. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.
| T-score | Edivoxetine |
|---|---|
| Satisfaction Week 12 | 0.31 ± 8.65 |
| Satisfaction Week 60 | -1.87 ± 9.49 |
| Satisfaction Week 156 | -1.74 ± 5.34 |
| Discomfort Week 12 | -0.22 ± 8.43 |
| Discomfort Week 60 | -2.89 ± 12.11 |
| Discomfort Week 156 | -0.09 ± 9.37 |
| Resilience Week 12 | 0.58 ± 10.93 |
| Resilience Week 60 | -1.07 ± 12.09 |
| Resilience Week 156 | 0.83 ± 9.33 |
| Risk Avoidance and Achievement Week 12 | 1.54 ± 8.10 |
| Risk Avoidance and Achievement Week 60 | 1.89 ± 8.95 |
| Risk Avoidance and Achievement Week 156 | 4.49 ± 13.89 |
| Achievement Week 12 | 2.75 ± 9.01 |
| Achievement Week 60 | 2.92 ± 10.58 |
| Achievement Week 156 | 4.28 ± 9.54 |
The EQ-5D-3L is a generic, multidimensional, health-related, quality-of-life (QoL) instrument that contains 2 parts: a health status profile and a visual analog scale to rate global health-related QoL. The profile allows respondents to rate their health state in 5 health dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels of measure: no problems, some problems, and severe problems. The 5 dimensions of the health state profile are reported as a population-based (UK or US) health index score of theoretically possible health states ranging from 0-1; where 0 is death and 1 is perfect health. i.e., higher is better. Parents of the participants completed the EQ-5D-3L form for rating their own quality of life.
| units on a scale | Edivoxetine |
|---|---|
| UK population-based Week 12 | -0.011 ± 0.194 |
| UK population-based Week 60 | -0.016 ± 0.203 |
| UK population-based Week 252 | 0.008 ± 0.087 |
| US population-based Week 12 | -0.009 ± 0.140 |
| US population-based Week 60 | -0.014 ± 0.144 |
| US population-based Week 252 | 0.019 ± 0.077 |
The EQ-5D-3L is a generic, multidimensional, health-related, QoL instrument that contains 2 parts: a health status profile and a visual analog scale to rate global health-related QoL. The visual analog scale reported records the respondent's self-rated health state on a vertical line where the endpoints are labeled 100 being "best imaginable health state" and 0 being "worst imaginable health state." Parents of the participants complete EQ-5D-3L form for rating their own health.
| units on a scale | Edivoxetine |
|---|---|
| Week 12 | -0.845 ± 21.908 |
| Week 60 | 2.968 ± 20.800 |
| Week 252 | 2.467 ± 14.252 |
The EQ-5D-3L is a generic, multidimensional, health-related, QoL instrument that contains 2 parts: a health status profile and a visual analog scale to rate global health-related QoL. The profile allows respondents to rate their health state in 5 health dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels of measure: no problems, some problems, and severe problems. The 5 dimensions of the health state profile are reported as a population-based (UK or US) health index score of theoretically possible health states ranging from 0-1; where 0 is death and 1 is perfect health. Parents of the participants aged 6 to 11 years completed the EQ-5D-3L form regarding the participants health-related quality of life. i.e., young children were unable to assess their own quality of life so the parents assessed the child's quality of life for them.
| units on a scale | Edivoxetine |
|---|---|
| UK population based Week 12 | 0.024 ± 0.132 |
| UK population based Week 60 | 0.010 ± 0.138 |
| UK population based Week 252 | 0.000 ± 0.000 |
| US population based Week 12 | 0.019 ± 0.109 |
| US population based Week 60 | 0.006 ± 0.109 |
| US population based Week 252 | 0.000 ± 0.000 |
EQ-5D-3L is a generic, multidimensional, health-related, QoL instrument that contains 2 parts: a health status profile and a visual analog scale to rate global health-related QoL. The visual analog scale reported records the respondent's self-rated health state on a vertical line where the endpoints are labeled 100 being "best imaginable health state" and 0 being "worst imaginable health state." Parents of the participants aged 6 to 11 years complete the EQ-5D-3L form for rating the participants health-related QoL, EQ-5D-3L. i.e., the young child was unable to assess their own quality of life then the parent assessed the child's quality of life.
| units on a scale | Edivoxetine |
|---|---|
| Week 12 | -2.389 ± 21.636 |
| Week 60 | 2.842 ± 15.023 |
| Week 252 | -1.667 ± 2.887 |
EQ-5D-3L is a generic, multidimensional, health-related, QoL instrument that contains 2 parts: a health status profile and a visual analog scale to rate global health-related QoL. The profile allows respondents to rate their health state in 5 health dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels of measure: no problems, some problems, and severe problems. The 5 dimensions of the health state profile are reported as a population-based (UK or US) health index score of theoretically possible health states ranging from 0-1; where 0 is death and 1 is perfect health. i.e., higher is better. Participants aged 12 years or older rate their own health-related quality of life using EQ-5D-3L.
| units on a scale | Edivoxetine |
|---|---|
| UK population based Week 12 | -0.010 ± 0.122 |
| UK population based Week 60 | -0.016 ± 0.217 |
| UK population based Week 252 | 0.008 ± 0.055 |
| US population based Week 12 | -0.008 ± 0.101 |
| US population based Week 60 | -0.005 ± 0.150 |
| US population based Week 252 | 0.013 ± 0.053 |
EQ-5D-3L is a generic, multidimensional, health-related, QoL instrument that contains 2 parts: a health status profile and a visual analog scale to rate global health-related QoL. The visual analog scale reported records the respondent's self-rated health state on a vertical line where the endpoints are labeled 100 being "best imaginable health state" and 0 or being "worst imaginable health state." Participants aged 12 years or older rated their own health-related quality of life using the EQ-5D-3L VAS scale.
| units on a scale | Edivoxetine |
|---|---|
| Week 12 | 2.364 ± 21.224 |
| Week 60 | 1.620 ± 18.025 |
| Week 252 | 1.200 ± 12.007 |
The Woodcock Johnson (WJ III ACH) (Woodcock 2001) is designed to measure academic achievement and evaluates a person aged 2 to 90 years and the tool takes 60 to 160 minutes to complete depending on a person's academic level. The WJ III ACH has 2 parallel forms (A and B) that can be administered in an alternating fashion. The WCJ III ACH uses standard scores (Deviation IQ) with an average standard score of 100 and a standard deviation of 15. Higher scores indicate better abilities/achievements. Lower scores indicate worse abilities/achievements.
| units on a scale | Edivoxetine |
|---|---|
| Mean Change From Baseline of Total Score Woodcock Johnson III Test of Achievement ([WJ III ACH]) | 0.05 ± 5.01 |
The WRAT 4 is a norm-referenced test that measures the basic academic skills of word reading, sentence comprehension, spelling, and math computation. There are 2 alternate forms (Blue Form, Green Form) that can be used interchangeably with comparable results. It can be used to evaluate a person aged 5 to 94 years and the administration time is 30 to 45 minutes for children (8 years or older) and adults, and 15 to 25 minutes for young children (ages 5 to 7 years). The age-normed standard scores range from 55 - 145 and for each subtest/composite includes word reading, sentence comprehension, spelling, math computation and reading composite. Higher scores indicate better abilities/achievements. Lower scores indicate worse abilities/achievements.
| units on a scale | Edivoxetine |
|---|---|
| Word Reading | -3.30 ± 25.84 |
| Sentence Comprehension | -1.80 ± 25.94 |
| Spelling | -6.40 ± 22.08 |
| Math Computation | -8.50 ± 25.21 |
| Reading Composite | 16.20 ± 36.10 |
The fourth edition of the WISC assessment (WISC-IV®) is administered to children ranging from 6 years to 16 years, 11 months. It contains 10 core subtests and 5 supplementary subtests, and takes 65-80 minutes to complete. In this study, Digit Span and Letter-Number Sequencing subtests were completed. Scaled scores range from 1 to 19. Higher scores denote better performance. Lower scores denote worse performance.
| units on a scale | Edivoxetine |
|---|---|
| Digit Span Scaled Score | 0.61 ± 2.42 |
| Letter-Number Sequencing Scaled Score | 0.63 ± 2.53 |
The WAIS-III® was used in the participants aged 17 years or older. Comprehensive reporting on the participant's intellectual ability is not required in this study. Raw scores for each of the 14 subtests are reported. Raw score ranges for each subtest are as follows: picture completion (0-25), vocabulary (0-66), digit symbol coding (0-133), similarities (0-33), block design (0-68), arithmetic (0-22), matrix reasoning (0-26), digit span forward and backward total (0-30), information (0-28), picture arrangement (0-22), comprehension (0-33), symbol search (0-60), letter-number sequencing (0-21), and object assembly (0-52). Higher scores reflect better performance and lower scores reflect lower performance.
| units on a scale | Edivoxetine |
|---|---|
| Picture Completion | 0.50 ± 0.71 |
| Vocabulary | -11.50 ± 12.02 |
| Digit-Symbol Coding | -22.00 ± 39.60 |
| Similarities | 4.00 ± 7.07 |
| Block Design | -8.00 ± 29.70 |
| Arithmetic | 6.00 ± 9.90 |
| Matrix Reasoning | 3.50 ± 2.12 |
| Digit Span | 4.00 ± 2.83 |
| Information | 3.50 ± 2.12 |
| Picture Arrangement | -2.50 ± 0.71 |
| Comprehension | -9.00 ± 11.31 |
| Symbol Search | -5.00 ± 7.07 |
| Letter Number Sequencing | 7.50 ± 12.02 |
| Object Assembly | -10.00 ± 18.38 |
Collected over Overall edivoxetine treatment adverse event data were collected for up to 5 years.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Edivoxetine (Open-Label) | — | 7/264 (2.7%) | 155/264 (58.7%) |
| Edivoxetine (Follow Up) | — | 1/80 (1.3%) | 5/80 (6.3%) |
| Event | Edivoxetine (Open-Label) | Edivoxetine (Follow Up) |
|---|---|---|
| EpilepsyNervous system disorders | 0/264 | 1/80 |
| AppendicitisInfections and infestations | 1/264 | 0/80 |
| Dengue feverInfections and infestations | 1/264 | 0/80 |
| Ankle fractureInjury, poisoning and procedural complications | 1/264 | 0/80 |
| ContusionInjury, poisoning and procedural complications | 1/264 | 0/80 |
| Intentional product misuseInjury, poisoning and procedural complications | 1/264 | 0/80 |
| Road traffic accidentInjury, poisoning and procedural complications | 1/264 | 0/80 |
| Skin abrasionInjury, poisoning and procedural complications | 1/264 | 0/80 |
| Affective disorderPsychiatric disorders | 1/264 | 0/80 |
| Suicidal ideationPsychiatric disorders | 1/264 | 0/80 |
| Event | Edivoxetine (Open-Label) | Edivoxetine (Follow Up) |
|---|---|---|
| VomitingGastrointestinal disorders | 45/264 | 0/80 |
| HeadacheNervous system disorders | 45/264 | 0/80 |
| NauseaGastrointestinal disorders | 35/264 | 0/80 |
| Upper respiratory tract infectionInfections and infestations | 35/264 | 2/80 |
| Abdominal pain upperGastrointestinal disorders | 22/264 | 2/80 |
| IrritabilityPsychiatric disorders | 22/264 | 0/80 |
| NasopharyngitisInfections and infestations | 18/264 | 0/80 |
| FatigueGeneral disorders | 16/264 | 0/80 |
| Gastroenteritis viralInfections and infestations | 15/264 | 0/80 |
| Pharyngitis streptococcalInfections and infestations | 15/264 | 0/80 |
| Age, Continuous(years) | All Participants |
|---|---|
| Mean | 11.64 ± 2.99 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 79 |
| Male | 188 |
| Ethnicity (NIH/OMB)(Participants) | All Participants |
|---|---|
| Hispanic or Latino | 65 |
| Not Hispanic or Latino | 202 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | All Participants |
|---|---|
| American Indian or Alaska Native | 2 |
| Asian | 11 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 60 |
| White | 180 |
| More than one race | 14 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | All Participants |
|---|---|
| Canada | 9 |
| Puerto Rico | 11 |
| United States | 235 |
| Taiwan | 10 |
| Mexico | 2 |
Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting information: Study protocol, Sap, Csr
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