A Phase 3 interventional study of Ziprasidone oral capsules in Schizophrenia, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Terminated at 68 sites in 9 countries. Open to participants aged 13 Years to 17 Years. Per ClinicalTrials.gov, last updated 2021-03-03.
Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Phase 3, Interventional, and Treatment
The purpose of this study is to assess the safety and tolerability of ziprasidone during long-term open-label administration in adolescents (ages 13-17) with schizophrenia.
On March 24, 2009, Pfizer Inc. stopped late stage Geodon pediatric clinical trials in schizophrenia (A1281134 - placebo controlled; A1281135 - open label). As recommended by the DSMB, these studies were stopped due to lack of efficacy. No safety concerns were identified.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 221 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is the lead sponsor of 431 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Ziprasidone oral capsules
Study medications will include oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength. Subjects will be dosed daily for 26 weeks using a flexible dose design with a minimal dose range of 20mg bid to a maximum dose range of 80 mg bid.
Also known as: Geodon, Zeldox
Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
All observed or volunteered treatment-emergent AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) were reported.
Time frame: 26 weeks
Number of Subjects With Change From Baseline to Each Pubertal Stage of Development as Assessed by the Tanner Adolescent Pubertal Self Assessment
Tanner Adolescent Pubertal Staging Questionnaire: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; males pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).
Time frame: Baseline, Week 26, Early Termination (ET)
Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score
CPBAQ: 19-item parent or legal guardian completed questionnaire to rate the child's verbal (such as yelling or cursing) and physical aggression (such a fighting with peers or being cruel to an animal) during the past week. Behavior was rated on a 4-point scale; range 0 (behavior did not occur or was not a problem) to 3 (behavior occurred a lot or was severe problem). Total score range 0 to 57; higher scores indicate a greater frequency and severity of aggression.
Time frame: Baseline, Weeks 2, 6, 18, 26, ET
Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score
CDRS-R: clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment.
Time frame: Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales
Computerized subject-administered test battery with subtests for verbal and visual memory, processing speed, nonverbal reasoning, executive functioning, working memory, sustained attention. Computerized 7- point sedation item (0 \[not sleepy\] to 10 \[very sleepy\]) was completed prior to test battery. Neurocognitive index score was derived from subtest scores per an algorithm. Index score and subtest scores assessed the subject's changes in cognition. Scores were rated as above average (score \>109), average (90 to 109), below average (80 to 89), or well below average (70 to 79).
Time frame: Baseline, Weeks 6 and 26, ET
Change From Baseline in CNS Vital Signs Cognitive Test Battery: Neurocognitive Index
Computerized subject-administered test battery with subtests for verbal and visual memory, processing speed, nonverbal reasoning, executive functioning, working memory, sustained attention. Computerized 7- point sedation item (0 \[not sleepy\] to 10 \[very sleepy\]) was completed prior to test battery. Neurocognitive index score was derived from subtest scores per an algorithm. Index score and subtest scores assessed the subject's changes in cognition. Scores were rated as above average (score \>109), average (90 to 109), below average (80 to 89), or well below average (70 to 79).
Time frame: Baseline, Weeks 6 and 26, ET
Change From Baseline in Simpson-Angus Rating Scale (SARS)
SARS: 10-item clinician rated instrument to assess parkinsonian symptoms (7 items) and related extrapyramidal side effects (3 items): gait, arm dropping, shoulder shaking, elbow rigidity, leg pendulousness, glabellar tap, tremor, and salivation. Head dropping (modified SARS item 7) substituted for head rotation. Anchored 5-point scale: range 0 (absence of condition, normal) to 4 (most extreme form of condition). Total score is sum of individual item scores (range 0 to 40); higher score indicates more affected.
Time frame: Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET
Change From Baseline in Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item
BAS: clinician rated scale to assess akathisia to determine the degree of subjective restlessness and distress associated with restlessness. First 3 items (Objective, Subjective, and Distress related to restlessness) rated on a 4-point scale with range 0 (no symptoms) to 3 (increased severity of symptoms). Item 4 Global Clinical Assessment of Akathisia rated on a 6- point scale range 0 (no symptoms) to 5 (increased severity of symptoms); higher score indicates increased severity. All rating are anchored. Only the Global Clinical Assessment of Akathisia was to be analyzed.
Time frame: Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score
AIMS: clinician rated 12-item scale to rate 7 body areas and global judgments on the severity of abnormal movements, incapacitation and subject's awareness of abnormal movements. Items 1 to 10 scored 0 (none) to 4 (severe) (total possible score 0 to 40; higher score indicates greater severity); items 11 to 14 are No or Yes response to dental status and sleep movements. Only the sum of the first 7 items to be analyzed (AIMS Movement Cluster score). Total score 0 to 28; higher score indicates greater severity.
Time frame: Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET
Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total Score
BPRS-A: 18-item clinician rated scale to assess somatic concern, anxiety, emotional withdrawal, disorganization, hallucinatory behavior, guilt feelings, suspiciousness, disorientation, tension, mannerisms, posturing, grandiosity, depressive mood, hostility, motor retardation, uncooperativeness, unusual thought content, blunted affect, excitement. Ratings anchored to improve consistency for single rater over time or between raters. Items rated on 7-point scale 0 (not present) to 6 (extremely severe). Total score=sum of items (range 0 to 108); higher scores indicate increased pathology.
Time frame: Baseline, Weeks 2, 6, 18, 26, ET
Change From Baseline in Children's Global Assessment Scale (CGAS)
CGAS: clinician-rated global assessment item for children based on symptoms and social functioning in home, school, and community settings. Scores on this single item range from 1 to 100 (higher levels indicate greater health) with descriptive anchors for every 10-point interval. Scores above 70 on this scale are considered within the "normal" range; lower score indicates need for increased supervision.
Time frame: Baseline, Weeks 2, 6, 18, 26, ET
Change From Baseline in Child Health Questionnaire (CHQ)
CHQ: 50-item, 15 subscale parent or legal guardian assessed instrument of child's physical, emotional, social well-being, and relative burden of disease on the parents; rated on Likert-type scale: range 0 to 100; higher scores indicate a more positive health status. Global indicators for Physical Health and Psychosocial Health are weighted composites derived from subscale items using scoring algorithms (transformed scores); range 0 to 100: higher scores indicate more positive health status.
Time frame: Baseline, Weeks 6 and 26, ET
Number of Subjects Per Response on the School Placement Questionnaire: School Situation
School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.
Time frame: Baseline, Weeks 6 and 26, ET
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance
School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.
Time frame: Baseline, Weeks 6 and 26, ET
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance
School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.
Time frame: Baseline, Weeks 6 and 26, ET
This study enrolled adolescent subjects with schizophrenia, ages 13-17 years, who participated in the double-blind placebo controlled Study A1281134 (NCT00257192) who met qualification criteria and wished to receive treatment with open-label ziprasidone.
| Milestone | Ziprasidone |
|---|---|
| Started | 221 |
| Completed | 76 |
| Not completed | 145 |
| Withdrew: Adverse event | 21 |
| Withdrew: Laboratory abnormality | 1 |
| Withdrew: Lost to follow-up | 3 |
| Withdrew: Lack of efficacy | 6 |
| Withdrew: Miscellaneous | 6 |
| Withdrew: Withdrawal by subject | 13 |
| Withdrew: Study terminated by sponsor | 94 |
| Withdrew: Death | 1 |
All observed or volunteered treatment-emergent AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) were reported.
| participants | Ziprasidone |
|---|---|
| AEs | 137 |
| SAEs | 16 |
Tanner Adolescent Pubertal Staging Questionnaire: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; males pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).
| participants | Ziprasidone |
|---|---|
| Pubic Hair, Week 26 (Stage 1) | 1 |
| Pubic Hair, Week 26 (Stage 2) | 1 |
| Pubic Hair, Week 26 (Stage 3) | 11 |
| Pubic Hair, Week 26 (Stage 4) | 39 |
| Pubic Hair, Week 26 (Stage 5) | 21 |
| Pubic Hair, ET (Stage 1) | 0 |
| Pubic Hair, ET (Stage 2) | 10 |
| Pubic Hair, ET (Stage 3) | 22 |
| Pubic Hair, ET (Stage 4) | 59 |
| Pubic Hair, ET (Stage 5) | 30 |
CPBAQ: 19-item parent or legal guardian completed questionnaire to rate the child's verbal (such as yelling or cursing) and physical aggression (such a fighting with peers or being cruel to an animal) during the past week. Behavior was rated on a 4-point scale; range 0 (behavior did not occur or was not a problem) to 3 (behavior occurred a lot or was severe problem). Total score range 0 to 57; higher scores indicate a greater frequency and severity of aggression.
| scores on a scale | Ziprasidone |
|---|---|
| Week 2 (n=178) | -0.3 ± 4.8 |
| Week 6 (n=153) | -0.8 ± 6.1 |
| Week 18 (n=93) | -0.5 ± 6.5 |
| Week 26 (n=68) | 0.7 ± 7.7 |
| ET (n=113) | 0.5 ± 7.1 |
| Week 26 LOCF (n=177) | -0.5 ± 7.0 |
CDRS-R: clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment.
| scores on a scale | Ziprasidone |
|---|---|
| Week 1 (n=198) | -1.4 ± 4.8 |
| Week 2 (n=188) | -2.2 ± 6.1 |
| Week 6 (n=160) | -3.5 ± 6.3 |
| Week 10 (n=129) | -4.6 ± 7.3 |
| Week 14 (n=105) | -5.0 ± 7.4 |
| Week 18 (n=94) | -4.9 ± 8.1 |
| Week 22 (n=78) | -5.1 ± 7.9 |
| Week 26 (n=72) | -5.3 ± 7.8 |
| ET (n=122) | -2.7 ± 7.3 |
| Week 26 LOCF (n=197) | -4.5 ± 7.0 |
Computerized subject-administered test battery with subtests for verbal and visual memory, processing speed, nonverbal reasoning, executive functioning, working memory, sustained attention. Computerized 7- point sedation item (0 \[not sleepy\] to 10 \[very sleepy\]) was completed prior to test battery. Neurocognitive index score was derived from subtest scores per an algorithm. Index score and subtest scores assessed the subject's changes in cognition. Scores were rated as above average (score \>109), average (90 to 109), below average (80 to 89), or well below average (70 to 79).
| scores on a scale | Ziprasidone |
|---|---|
| Sedation: Week 6 (n=149) | 0.1 ± 1.7 |
| Sedation: Week 26 (n=70) | -0.2 ± 1.5 |
| Sedation: ET (n=102) | -0.1 ± 2.0 |
| Sedation: Week 26 LOCF (n=153) | -0.2 ± 1.7 |
| Verbal Memory: Week 6 (n=150) | -1.3 ± 13.7 |
| Verbal Memory: Week 26 (n=71) | 0.6 ± 14.0 |
| Verbal Memory: ET (n=103) | -0.7 ± 14.6 |
| Verbal Memory: Week 26 LOCF (n=155) | 0.3 ± 14.5 |
| Visual Memory: Week 6 (n=148) | -3.6 ± 13.7 |
| Visual Memory: Week 26 (n=71) | -2.1 ± 15.5 |
| Visual Memory: ET (n=103) | -1.9 ± 12.7 |
| Visual Memory: Week 26 LOCF (n=154) | -1.5 ± 14.4 |
| Processing Speed: Week 6 (n=148) | -1.2 ± 11.4 |
| Processing Speed: Week 26 (n=71) | 2.1 ± 10.2 |
| Processing Speed: ET (n=103) | -1.4 ± 19.0 |
| Processing Speed: Week 26 LOCF (n=153) | 0.5 ± 12.0 |
| Reasoning: Week 6 (n=145) | -0.3 ± 14.1 |
| Reasoning: Week 26 (n=71) | 3.0 ± 11.3 |
| Reasoning: ET (n=100) | 1.9 ± 14.9 |
| Reasoning: Week 26 LOCF (n=151) | 1.5 ± 14.3 |
| Executive Functioning: Week 6 (n=145) | 2.0 ± 16.7 |
| Executive Functioning: Week 26 (n=71) | 2.0 ± 16.8 |
| Executive Functioning: ET (n=100) | 2.4 ± 15.7 |
| Executive Functioning: Week 26 LOCF (n=151) | 2.4 ± 16.9 |
| Working Memory: Week 6 (n=145) | -0.5 ± 12.6 |
| Working Memory: Week 26 (n=68) | 0.8 ± 16.4 |
| Working Memory: ET (n=99) | 0.3 ± 12.1 |
| Working Memory: Week 26 LOCF (n=150) | 0.7 ± 14.2 |
| Sustained Attention: Week 6 (n=145) | 0.2 ± 12.0 |
| Sustained Attention: Week 26 (n=68) | 1.9 ± 14.0 |
| Sustained Attention: ET (n=99) | -0.6 ± 12.2 |
| Sustained Attention: Week 26 LOCF (n=150) | 1.2 ± 12.7 |
Computerized subject-administered test battery with subtests for verbal and visual memory, processing speed, nonverbal reasoning, executive functioning, working memory, sustained attention. Computerized 7- point sedation item (0 \[not sleepy\] to 10 \[very sleepy\]) was completed prior to test battery. Neurocognitive index score was derived from subtest scores per an algorithm. Index score and subtest scores assessed the subject's changes in cognition. Scores were rated as above average (score \>109), average (90 to 109), below average (80 to 89), or well below average (70 to 79).
| scores on a scale | Ziprasidone |
|---|---|
| Neurocognitive Index: Week 6 (n=144) | -0.6 ± 7.2 |
| Neurocognitive Index: Week 26 (n=68) | 1.3 ± 7.3 |
| Neurocognitive Index: ET (n=99) | 0.5 ± 6.3 |
| Neurocognitive Index: Week 26 LOCF (n=150) | 0.7 ± 7.7 |
SARS: 10-item clinician rated instrument to assess parkinsonian symptoms (7 items) and related extrapyramidal side effects (3 items): gait, arm dropping, shoulder shaking, elbow rigidity, leg pendulousness, glabellar tap, tremor, and salivation. Head dropping (modified SARS item 7) substituted for head rotation. Anchored 5-point scale: range 0 (absence of condition, normal) to 4 (most extreme form of condition). Total score is sum of individual item scores (range 0 to 40); higher score indicates more affected.
| scores on a scale | Ziprasidone |
|---|---|
| Week 1 (n=206) | -0.05 ± 1.4 |
| Week 2 (n=197) | -0.11 ± 1.3 |
| Week 6 (n=168) | -0.04 ± 1.7 |
| Week 10 (n=135) | -0.10 ± 1.6 |
| Week 14 (n=110) | -0.02 ± 1.9 |
| Week 18 (n=99) | 0.02 ± 1.4 |
| Week 22 (n=82) | -0.04 ± 1.7 |
| Week 26 (n=76) | -0.32 ± 1.4 |
| ET (n=127) | -0.31 ± 2.0 |
| Week 26 LOCF (n=206) | -0.15 ± 1.5 |
BAS: clinician rated scale to assess akathisia to determine the degree of subjective restlessness and distress associated with restlessness. First 3 items (Objective, Subjective, and Distress related to restlessness) rated on a 4-point scale with range 0 (no symptoms) to 3 (increased severity of symptoms). Item 4 Global Clinical Assessment of Akathisia rated on a 6- point scale range 0 (no symptoms) to 5 (increased severity of symptoms); higher score indicates increased severity. All rating are anchored. Only the Global Clinical Assessment of Akathisia was to be analyzed.
| scores on a scale | Ziprasidone |
|---|---|
| Week 1 (n=206) | 0.0 ± 0.4 |
| Week 2 (n=197) | 0.0 ± 0.4 |
| Week 6 (n=168) | 0.0 ± 0.4 |
| Week 10 (n=135) | 0.0 ± 0.5 |
| Week 14 (n=110) | 0.1 ± 0.6 |
| Week 18 (n=99) | 0.0 ± 0.4 |
| Week 22 (n=82) | 0.0 ± 0.6 |
| Week 26 (n=76) | 0.0 ± 0.6 |
| ET (n=127) | 0.0 ± 0.5 |
| Week 26 LOCF (n=206) | 0.1 ± 0.5 |
AIMS: clinician rated 12-item scale to rate 7 body areas and global judgments on the severity of abnormal movements, incapacitation and subject's awareness of abnormal movements. Items 1 to 10 scored 0 (none) to 4 (severe) (total possible score 0 to 40; higher score indicates greater severity); items 11 to 14 are No or Yes response to dental status and sleep movements. Only the sum of the first 7 items to be analyzed (AIMS Movement Cluster score). Total score 0 to 28; higher score indicates greater severity.
| scores on a scale | Ziprasidone |
|---|---|
| Week 1 (n=206) | 0.06 ± 1.3 |
| Week 2 (n=197) | -0.05 ± 0.7 |
| Week 6 (n=168) | -0.04 ± 0.9 |
| Week 10 (n=135) | 0.02 ± 1.4 |
| Week 14 (n=110) | 0.01 ± 0.9 |
| Week 18 (n=99) | 0.01 ± 0.6 |
| Week 22 (n=82) | 0.10 ± 1.2 |
| Week 26 (n=76) | 0.08 ± 1.2 |
| ET (n=127) | -0.12 ± 1.5 |
| Week 26 LOCF (n=206) | 0.00 ± 1.0 |
BPRS-A: 18-item clinician rated scale to assess somatic concern, anxiety, emotional withdrawal, disorganization, hallucinatory behavior, guilt feelings, suspiciousness, disorientation, tension, mannerisms, posturing, grandiosity, depressive mood, hostility, motor retardation, uncooperativeness, unusual thought content, blunted affect, excitement. Ratings anchored to improve consistency for single rater over time or between raters. Items rated on 7-point scale 0 (not present) to 6 (extremely severe). Total score=sum of items (range 0 to 108); higher scores indicate increased pathology.
| scores on a scale | Ziprasidone |
|---|---|
| Week 2 (n=196) | -3.8 ± 7.8 |
| Week 6 (n=167) | -6.1 ± 8.8 |
| Week 18 (n=98) | -7.8 ± 11.0 |
| Week 26 (n=75) | -8.5 ± 9.9 |
| ET (n=127) | -4.0 ± 9.1 |
| Week 26 LOCF (n=196) | -6.9 ± 8.9 |
CGAS: clinician-rated global assessment item for children based on symptoms and social functioning in home, school, and community settings. Scores on this single item range from 1 to 100 (higher levels indicate greater health) with descriptive anchors for every 10-point interval. Scores above 70 on this scale are considered within the "normal" range; lower score indicates need for increased supervision.
| scores on a scale | Ziprasidone |
|---|---|
| Week 2 (n=197) | 55.5 ± 12.9 |
| Week 6 (n=168) | 59.2 ± 12.5 |
| Week 18 (n=99) | 62.3 ± 11.4 |
| Week 26 (n=76) | 65.6 ± 12.4 |
| ET (n=127) | 56.6 ± 15.1 |
| Week 26 LOCF (n=197) | 60.5 ± 14.2 |
CHQ: 50-item, 15 subscale parent or legal guardian assessed instrument of child's physical, emotional, social well-being, and relative burden of disease on the parents; rated on Likert-type scale: range 0 to 100; higher scores indicate a more positive health status. Global indicators for Physical Health and Psychosocial Health are weighted composites derived from subscale items using scoring algorithms (transformed scores); range 0 to 100: higher scores indicate more positive health status.
| scores on a scale | Ziprasidone |
|---|---|
| Global Health: Week 6 (n=163) | 44.2 ± 23.9 |
| Global Health: Week 26 (n=75) | 50.3 ± 22.1 |
| Global Health: ET (n=124) | 40.5 ± 25.8 |
| Global Health: Week 26 LOCF (n=164) | 44.9 ± 22.9 |
| Global Behavior: Week 6 (n=163) | 44.9 ± 23.6 |
| Global Behavior: Week 26 (n=75) | 47.0 ± 24.2 |
| Global Behavior: ET (n=124) | 38.7 ± 25.8 |
| Global Behavior: Week 26 LOCF (n=164) | 43.8 ± 24.4 |
| Family Cohesion: Week 6 (n=163) | 53.0 ± 23.9 |
| Family Cohesion: Week 26 (n=75) | 54.4 ± 24.7 |
| Family Cohesion: ET (n=124) | 50.0 ± 23.9 |
| Family Cohesion: Week 26 LOCF (n=164) | 53.4 ± 23.7 |
| Physical Health: Week 6 (n=163) | 76.4 ± 30.8 |
| Physical Health: Week 26 (n=74) | 80.2 ± 28.8 |
| Physical Health: ET (n=123) | 75.5 ± 32.8 |
| Physical Health: Week 26 LOCF (n=163) | 77.8 ± 31.2 |
| Bodily Pain: Week 6 (n=163) | 80.8 ± 21.6 |
| Bodily Pain: Week 26 (n=75) | 84.4 ± 21.5 |
| Bodily Pain: ET (n=124) | 81.0 ± 22.7 |
| Bodily Pain: Week 26 LOCF (n=164) | 82.5 ± 21.3 |
| Emotion, Behavior: Week 6 (n=163) | 53.3 ± 32.6 |
| Emotion, Behavior: Week 26 (n=74) | 60.1 ± 31.2 |
| Emotion, Behavior: ET (n=123) | 49.5 ± 34.5 |
| Emotion, Behavior: Week 26 LOCF (n=163) | 54.8 ± 32.2 |
| Time Impact on Parent: Week 6 (n=163) | 62.0 ± 26.6 |
| Time Impact on Parent: Week 26 (n=75) | 69.9 ± 23.5 |
| Time Impact on Parent: ET (n=124) | 59.9 ± 28.6 |
| Time Impact on Parent: Week 26 LOCF (n=164) | 65.1 ± 26.3 |
| Emotional Impact on Parent: Week 6 (n=163) | 49.5 ± 24.6 |
| Emotional Impact on Parent: Week 26 (n=75) | 57.2 ± 24.7 |
| Emotional Impact on Parent: ET (n=124) | 43.4 ± 25.9 |
| Emotional Impact on Parent: Week 26 LOCF (n=164) | 52.2 ± 26.0 |
| Mental Health: Week 6 (n=163) | 63.6 ± 16.1 |
| Mental Health: Week 26 (n=75) | 66.7 ± 16.5 |
| Mental Health: ET (n=124) | 60.8 ± 18.3 |
| Mental Health: Week 26 LOCF (n=164) | 65.1 ± 16.1 |
| Physical Function: Week 6 (n=163) | 80.4 ± 22.3 |
| Physical Function: Week 26 (n=75) | 84.9 ± 19.0 |
| Physical Function: ET (n=124) | 79.5 ± 23.4 |
| Physical Function: Week 26 LOCF (n=164) | 81.4 ± 21.9 |
| Behavior Scale: Week 6 (n=163) | 62.7 ± 16.8 |
| Behavior Scale: Week 26 (n=75) | 64.5 ± 20.0 |
| Behavior Scale: ET (n=124) | 60.2 ± 18.7 |
| Behavior Scale: Week 26 LOCF (n=164) | 63.0 ± 18.4 |
| Self-Esteem: Week 6 (n=163) | 52.7 ± 20.3 |
| Self-Esteem: Week 26 (n=74) | 55.3 ± 21.0 |
| Self-Esteem: ET (n=124) | 52.6 ± 21.7 |
| Self-Esteem: Week 26 LOCF (n=163) | 54.5 ± 20.6 |
| General Health Perception: Week 6 (n=163) | 50.3 ± 15.3 |
| General Health Perception: Week 26 (n=75) | 51.8 ± 16.4 |
| General Health Perception: ET (n=124) | 49.7 ± 15.1 |
| General Health Perception: Week 26 LOCF (n=164) | 50.3 ± 15.4 |
| Family Activities: Week 6 (n=163) | 60.1 ± 24.9 |
| Family Activities: Week 26 (n=75) | 63.9 ± 24.1 |
| Family Activities: ET (n=124) | 56.3 ± 27.6 |
| Family Activities: Week 26 LOCF (n=164) | 61.6 ± 26.1 |
| Physical Health Global Subscale: Week 6 (n=163) | 44.1 ± 11.7 |
| Physical Health Global Subscale: Week 26 (n=74) | 46.6 ± 10.9 |
| Physical Health Global: ET (n=123) | 43.8 ± 12.9 |
| Physical Health Global: Week 26 LOCF (n=163) | 44.8 ± 12.2 |
| Psychosocial Health Global: Week 6 (n=163) | 35.7 ± 10.4 |
| Psychosocial Health Global: Week 26 (n=74) | 38.5 ± 10.9 |
| Psychosocial Health Global: ET (n=123) | 33.7 ± 11.9 |
| Psychosocial Health Global: Week 26 LOCF (n=163) | 36.8 ± 10.7 |
School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.
| participants | Ziprasidone |
|---|---|
| Baseline: Enrolled or Attend (n=221) | 63 |
| Baseline: Not Attend or Mental Illness (n=221) | 59 |
| Baseline: Not Attend or Other (n=221) | 4 |
| Baseline: Enrolled or Vacation (n=221) | 26 |
| Baseline: Not Enrolled or Mental Illness (n=221) | 42 |
| Baseline: Not Enrolled or Other (n=221) | 27 |
| Week 6: Enrolled or Attend (n=166) | 68 |
| Week 6: Not Attend or Mental Illness (n=166) | 32 |
| Week 6: Not Attend or Other (n=166) | 1 |
| Week 6: Enrolled or Vacation (n=166) | 14 |
| Week 6: Not Enrolled or Mental Illness (n=166) | 29 |
| Week 6: Not Enrolled or Other (n=166) | 22 |
| Week 26: Enrolled or Attend (n=75) | 35 |
| Week 26: Not Attend or Mental Illness (n=75) | 9 |
| Week 26: Not Attend or Other (n=75) | 0 |
| Week 26: Enrolled or Vacation (n=75) | 5 |
| Week 26: Not Enrolled or Mental Illness (n=75) | 13 |
| Week 26: Not Enrolled or Other (n=75) | 13 |
| ET: Enrolled or Attend (n=125) | 42 |
| ET: Not Attend or Mental Illness (n=125) | 35 |
| ET: Not Attend or Other (n=125) | 1 |
| ET: Enrolled or Vacation (n=125) | 9 |
| ET: Not Enrolled or Mental Illness (n=125) | 21 |
| ET: Not Enrolled or Other (n=125) | 17 |
| Week 26 LOCF: Enrolled or Attend (n=166) | 75 |
| Week 26 LOCF: Not Attend or Mental Illness (n=166) | 30 |
| Week 26 LOCF: Not Attend or Other (n=166) | 1 |
| Week 26 LOCF: Enrolled or Vacation (n=166) | 8 |
| Wk 26 LOCF: Not Enrolled or Mental Illness (n=166) | 28 |
| Week 26 LOCF: Not Enrolled or Other (n=166) | 24 |
School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.
| participants | Ziprasidone |
|---|---|
| Baseline: No Absences (n=133) | 25 |
| Baseline: Only a Few Absences (n=133) | 37 |
| Baseline: Frequent Absences (n=133) | 12 |
| Baseline: Did Not Attend (n=133) | 36 |
| Baseline: Not Applicable or Vacation (n=133) | 23 |
| Week 6: No Absences (n=95) | 31 |
| Week 6: Only a Few Absences (n=95) | 29 |
| Week 6: Frequent Absences (n=95) | 11 |
| Week 6: Did Not Attend (n=95) | 10 |
| Week 6: Not Applicable or Vacation (n=95) | 14 |
| Week 26: No Absences (n=42) | 14 |
| Week 26: Only a Few Absences (n=42) | 16 |
| Week 26: Frequent Absences (n=42) | 7 |
| Week 26: Did Not Attend (n=42) | 0 |
| Week 26: Not Applicable or Vacation (n=42) | 5 |
| ET: No Absences (n=62) | 16 |
| ET: Only a Few Absences (n=62) | 23 |
| ET: Frequent Absences (n=62) | 5 |
| ET: Did Not Attend (n=62) | 11 |
| ET: Not Applicable or Vacation (n=62) | 7 |
| Week 26 LOCF: No Absences (n=93) | 32 |
| Week 26 LOCF: Only a Few Absences (n=93) | 32 |
| Week 26 LOCF: Frequent Absences (n=93) | 14 |
| Week 26 LOCF: Did Not Attend (n=93) | 7 |
| Week 26 LOCF: Not Applicable or Vacation (n=93) | 8 |
School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.
| participants | Ziprasidone |
|---|---|
| Baseline: Excellent (n=103) | 5 |
| Baseline: Good (n=103) | 25 |
| Baseline: Fair (n=103) | 40 |
| Baseline: Poor (n=103) | 23 |
| Baseline: Very Poor (n=103) | 10 |
| Week 6: Excellent (n=73) | 2 |
| Week 6: Good (n=73) | 23 |
| Week 6: Fair (n=73) | 34 |
| Week 6: Poor (n=73) | 14 |
| Week 6: Very Poor (n=73) | 0 |
| Week 26: Excellent (n=37) | 1 |
| Week 26: Good (n=37) | 10 |
| Week 26: Fair (n=37) | 18 |
| Week 26: Poor (n=37) | 5 |
| Week 26: Very Poor (n=37) | 3 |
| ET: Excellent (n=48) | 0 |
| ET: Good (n=48) | 15 |
| ET: Fair (n=48) | 23 |
| ET: Poor (n=48) | 6 |
| ET: Very Poor (n=48) | 4 |
| Week 26 LOCF: Excellent (n=80) | 1 |
| Week 26 LOCF: Good (n=80) | 22 |
| Week 26 LOCF: Fair (n=80) | 39 |
| Week 26 LOCF: Poor (n=80) | 15 |
| Week 26 LOCF: Very Poor (n=80) | 3 |
Collected over Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ziprasidone | — | 16/221 (7.2%) | 68/221 (30.8%) |
| Event | Ziprasidone |
|---|---|
| SchizophreniaPsychiatric disorders | 4/221 |
| Suicidal ideationPsychiatric disorders | 3/221 |
| Hallucination, auditoryPsychiatric disorders | 2/221 |
| Obsessive-compulsive disorderPsychiatric disorders | 2/221 |
| Self injurious behaviourPsychiatric disorders | 2/221 |
| Drug ineffectiveGeneral disorders | 1/221 |
| DystoniaNervous system disorders | 1/221 |
| AggressionPsychiatric disorders | 1/221 |
| AgitationPsychiatric disorders | 1/221 |
| AnxietyPsychiatric disorders | 1/221 |
| Event | Ziprasidone |
|---|---|
| SomnolenceNervous system disorders | 33/221 |
| HeadacheNervous system disorders | 20/221 |
| TremorNervous system disorders | 14/221 |
| FatigueGeneral disorders | 11/221 |
| InsomniaPsychiatric disorders | 11/221 |
| Age, Customized(Participants) | Ziprasidone |
|---|---|
| >12 years and <13 years at start of treatment | 3 |
| 13 to 17 years | 218 |
| Sex: Female, Male(Participants) | Ziprasidone |
|---|---|
| Female | 90 |
| Male | 131 |
This study is terminated, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.