A Phase 3 interventional study of Brexpiprazole in Major Depressive Disorder and Irritability, sponsored by H. Lundbeck A/S. Completed at 15 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-03-15.
Sponsored by H. Lundbeck A/S · Phase 3, Interventional, and Treatment
To explore the anti-impulsive and anti-aggressive properties of brexpiprazole in a naturalistic setting of depressed patients with irritability.
2,805 studies on the registry are indexed under Depressive Disorder, Major; 565 are open to participants now.
This study's enrollment of 55 is below the median of 80 across 2,338 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →H. Lundbeck A/S is the lead sponsor of 224 studies on the registry; 9 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 10 (30%) have results posted.
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Main selection criteria at screening visit:
Main inclusion criteria at baseline visit:
Exclusion Criteria:
Other inclusion and exclusion criteria may apply.
Brexpiprazole adjunct to open-label commercially available Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin Norepinephrine Reuptake Inhibitor (SNRI) antidepressant treatment (ADT)
Drug: Brexpiprazole
2-3 mg/day, once daily dose, tablets, for oral use. The patients received 1mg/day brexpiprazole during Week 1 and 2mg/day during Week 2 (up-titration) and from Weeks 3 to 6 they received 3mg/day; depending on tolerability the dose could be reduced to 2mg/day based on the investigator's judgement.
Change From Baseline to Week 6 in SIS Total Score
The Sheehan Irritability Scale (SIS) is a patient-rated scale designed to measure irritability. The SIS consists of 7 subscales assessing irritability, frustration, edginess/impatience/overreaction, moodiness, anger with self, anger with others, and temper. The subscales are summarised to give the total score which ranges from 0 to 70, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time frame: Baseline and Week 6
Change From Baseline to Week 6 in SIS Item 1 Score
The Sheehan Irritability Scale (SIS) is a patient-rated scale designed to measure irritability. The SIS item 1 assess how much the patient has suffered from irritability in the past week. The SIS item 1 ranged from 0 to 10 with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time frame: Baseline and Week 6
Change From Baseline to Week 6 in IDS-C30 Item 6 Score
The 30-item Inventory of Depressive Symptomatology - Clinician-Rated (IDS-C30) is a clinician-rated scale designed to assess the severity of depressive symptoms. The IDS-C30 item 6 measures mood (irritable) and is rated on a 4-point anchored scale from 0 (least severe) to 3 (most severe) with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time frame: Baseline and Week 6
Change From Baseline to Week 6 in Delay Discounting - Log-transformed MCQ Scores
The Monetary Choice Questionnaire (MCQ) is a patient-completed questionnaire designed to measure delay discounting, an index of impulsive behaviour. The MCQ consists of 27 choices between immediate and delayed rewards. The patients choose repeatedly between two hypothetical sums of money: a smaller amount now or a larger amount in the future (for example, ''Would you prefer $27 today or $50 in 21 days?"). The answers provide an estimate of the patient's discounting rate. The discounting rate parameter takes values between 0 and 1 and higher discounting rates indicate impulsivity. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time frame: Baseline and Week 6
Change From Baseline to Week 6 in BIS-11 Total Score
The Barratt Impulsiveness Scale, Version 11 (BIS-11) is a patient-rated scale designed to assess impulsive personality traits. The BIS-11 consists of 30 items scored on a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). The total score ranges from 30 to 120 with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time frame: Baseline and Week 6
Change From Baseline to Week 6 in KSQ Anger-hostility Subscore
The Kellner Symptom Questionnaire (KSQ) is a patient-rated scale designed to assess distress using symptoms of depression, anxiety, anger-hostility, and somatization. The KSQ anger-hostility subscale score ranges from 0 to 23 with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time frame: Baseline and Week 6
Shift From Baseline to Week 6 in Anger Attacks (AAQ)
The Anger Attacks Questionnaire (AAQ) is a patient-rated scale designed to assess the presence of anger attacks over a period of time. The AAQ consists of 7 items. Patients are classified as having anger attacks when exhibiting the following 4 criteria: 1) irritability, 2) overreaction to minor annoyances, 3) occurrence of anger attacks (at least one of which occurred within the period), and 4) experienced 4 or more specific symptoms during at least one of the attacks. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time frame: Baseline and Week 6
Change From Baseline to Week 6 in IDS-C30 Total Score
The 30-item Inventory of Depressive Symptomatology - Clinician-Rated (IDS-C30) is a clinician-rated scale designed to assess the severity of depressive symptoms. The IDS-C30 consists of 30 items assessing the symptoms of depression, as well as commonly associated symptoms (for example, anxiety, irritability), and topics relevant to melancholic or atypical features; the patient rates only one of the 2 items assessing appetite (decreased or increased), and only one of the 2 items assessing weight (loss or gain). Each of the items is rated on a 4-point anchored scale from 0 (least severe) to 3 (most severe). The total score is the sum of the 28 scored items, and ranges from 0 to 84, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time frame: Baseline and Week 6
Change From Baseline to Week 6 in KSQ Depression Subscore
The Kellner Symptom Questionnaire (KSQ) is a patient-rated scale designed to assess distress using symptoms of depression, anxiety, anger-hostility, and somatization. The KSQ depression subscale score ranges from 0 to 23, with higher values indicating worse outcome . As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time frame: Baseline and Week 6
Change From Baseline to Week 6 in MADRS Total Score
The Montgomery and Åsberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time frame: Baseline and Week 6
Change From Baseline to Week 6 in CPFQ Total Score
The Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) is a patient-rated scale designed to assess cognitive and executive dysfunction including symptoms of fatigue in mood and anxiety disorders. The CPFQ consists of 7 items, each rated on a scale from 1 (greater than normal functioning) to 6 (poorer than normal functioning). The total score of the 7 items ranges from 7 to 42, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time frame: Baseline and Week 6
Change From Baseline to Week 6 in CGI-S Score
The Clinical Global Impression severity of illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients). As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time frame: Baseline and Week 6
CGI-I Score at Week 6
The Clinical Global Impression - global improvement CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time frame: Week 6
Change From Baseline to Week 6 in KSQ Total Score
The Kellner Symptom Questionnaire (KSQ) is a patient-rated scale designed to assess distress using symptoms of depression, anxiety, anger-hostility, and somatization. The KSQ consists of 92 items which form the basis for the four subscales: depression, anxiety, anger-hostility, and somatic; of which 68 items indicate symptoms (symptom subscales) and 24 items are antonyms of some of the symptoms and indicate well-being (well-being subscales). A "yes" or "true" response on the symptom subscales scores 1, and a "no" or "false" on the well-being subscales scores 1. The maximum score for each symptom subscale is 17, and the maximum score for each well-being subscale is 6. The score of each subscale ranges from 0 to 23 (the sum of the symptom subscale and the well-being subscale). A higher score indicates more distress. The total score ranges from 0 to 92. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time frame: Baseline and Week 6
Change From Baseline to Week 6 in Delay Discounting - Log-transformed EDT DPDT Scores
DPDT consists of approximately 110 choices between an immediate reward or a higher delayed reward, and between an immediate reward or a higher reward that only comes with a certain probability. The tasks are scored independently of each other and do not yield a total score. There will be two derived variables from this task; a delayed discounting rate and a probability discounting rate. The delay discounting value takes values from 0 and up, a higher delay discounting value indicates greater impulsivity. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time frame: Baseline and Week 6
Change From Baseline to Week 6 in Delay Discounting - EDT DRT Score
DRT consists of 60 choices between an immediate reward or a higher delayed reward. The number of impulsive choices will be a continuous variable estimated from how many immediate choices based on 60 possible. The number ranges between 0 and 60, with a higher value indicating more impulsivity. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time frame: Baseline and Week 6
Change From Week 6 to Week 10 in SIS Total Score
The Sheehan Irritability Scale (SIS) is a patient-rated scale designed to measure irritability. The SIS consists of 7 subscales assessing irritability, frustration, edginess/impatience/overreaction, moodiness, anger with self, anger with others, and temper. The patient rates the extent to which they have suffered from these symptoms. Each subscale has verbal descriptors (not at all, mildly, moderately, markedly, and extremely) as well as numerical scores from 0 (not at all) to 10 (extremely) that provide more precise levels of the verbal descriptors. One additional question assesses number of days impaired by irritability over the period. The subscales are summarised to give the total score which ranges from 0 to 70, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time frame: Week 6 and Week 10
Change From Week 6 to Week 10 in SIS Item 1 Score
The Sheehan Irritability Scale (SIS) is a patient-rated scale designed to measure irritability. The SIS item 1 assess how much the patient has suffered from irritability in the past week, using verbal descriptors (not at all, mildly, moderately, markedly, and extremely) as well as numerical scores from 0 (not at all) to 10 (extremely) that provide more precise levels of the verbal descriptors. The SIS item 1 ranged from 0 to 10 with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time frame: Week 6 and Week 10
Change From Week 6 to Week 10 in Delay Discounting - MCQ Scores
The Monetary Choice Questionnaire (MCQ) is a patient-completed questionnaire designed to measure delay discounting, an index of impulsive behaviour. The MCQ consists of 27 choices between immediate and delayed rewards. The patients choose repeatedly between two hypothetical sums of money: a smaller amount now or a larger amount in the future (for example, ''Would you prefer $27 today or $50 in 21 days?"). The answers provide an estimate of the patient's discounting rate. The discounting rate parameter takes values between 0 and 1 and higher discounting rates indicate impulsivity. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time frame: Week 6 and Week 10
Change From Week 6 to Week 10 in BIS-11 Total Score
The Barratt Impulsiveness Scale, Version 11 (BIS-11) is a patient-rated scale designed to assess impulsive personality traits. The BIS-11 consists of 30 items scored on a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). The scores provide information to assess 6 first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and 3 second-order factors (motor impulsiveness, non-planning impulsiveness, and attentional impulsiveness). The total score ranges from 30 to 120 with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time frame: Week 6 and Week 10
Change From Week 6 to Week 10 in KSQ Anger-hostility Subscore
The Kellner Symptom Questionnaire (KSQ) is a patient-rated scale designed to assess distress using symptoms of depression, anxiety, anger-hostility, and somatization. The KSQ anger-hostility subscale score ranges from 0 to 23 with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time frame: Week 6 and Week 10
Change From Week 6 to Week 10 in KSQ Depression Subscore
The Kellner Symptom Questionnaire (KSQ) is a patient-rated scale designed to assess distress using symptoms of depression, anxiety, anger-hostility, and somatization. The KSQ depression subscale score ranges from 0 to 23, with higher values indicating worse outcome . As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time frame: Week 6 and Week 10
Change From Week 6 to Week 10 in CGI-S Score
The Clinical Global Impression severity of illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients). As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time frame: Week 6 and Week 10
Change From Baseline to Week 6 in MADRS Total Score in Patients With a Pre-defined Baseline BIS-11 Total Score
The Montgomery and Åsberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome. Subgroup analyses were performed for the change from Baseline to Week 6 in MADRS total score based on the patients' BIS-11 total score at Baseline. The subgroups denoted BIS-11\_HIGH had a BIS-11 total score at Baseline ≥median at baseline and the subgroups denoted BIS-11\_LOW had a BIS-11 total score \<median at baseline. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time frame: Baseline and Week 6
Change From Baseline to Week 6 in CGI-S Score in Patients With a Pre-defined Baseline BIS-11 Total Score
The subgroups denoted BIS-11\_HIGH had a BIS-11 total score at Baseline ≥median at baseline and the subgroups denoted BIS-11\_LOW had a BIS-11 total score \<median at baseline. The Clinical Global Impression severity of illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients). As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time frame: Baseline and Week 6
CGI-I Score at Week 6 Patients With a Pre-defined Baseline BIS-11 Total Score
The subgroups denoted BIS-11\_HIGH had a BIS-11 total score at Baseline ≥median at baseline and the subgroups denoted BIS-11\_LOW had a BIS-11 total score \<median at baseline. The Clinical Global Impression - global improvement CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
Time frame: Week 6
| Milestone | Brexpiprazole |
|---|---|
| Started | 54 |
| Completed | 50 |
| Not completed | 4 |
| Withdrew: Adverse event | 2 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Protocol violation | 1 |
The Sheehan Irritability Scale (SIS) is a patient-rated scale designed to measure irritability. The SIS consists of 7 subscales assessing irritability, frustration, edginess/impatience/overreaction, moodiness, anger with self, anger with others, and temper. The subscales are summarised to give the total score which ranges from 0 to 70, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
| units on a scale | Brexpiprazole |
|---|---|
| Change From Baseline to Week 6 in SIS Total Score | -21.13 ± 2.55 |
The Sheehan Irritability Scale (SIS) is a patient-rated scale designed to measure irritability. The SIS item 1 assess how much the patient has suffered from irritability in the past week. The SIS item 1 ranged from 0 to 10 with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
| units on a scale | Brexpiprazole |
|---|---|
| Change From Baseline to Week 6 in SIS Item 1 Score | -3.45 ± 0.36 |
The 30-item Inventory of Depressive Symptomatology - Clinician-Rated (IDS-C30) is a clinician-rated scale designed to assess the severity of depressive symptoms. The IDS-C30 item 6 measures mood (irritable) and is rated on a 4-point anchored scale from 0 (least severe) to 3 (most severe) with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
| units on a scale | Brexpiprazole |
|---|---|
| Change From Baseline to Week 6 in IDS-C30 Item 6 Score | -1.22 ± 0.13 |
The Monetary Choice Questionnaire (MCQ) is a patient-completed questionnaire designed to measure delay discounting, an index of impulsive behaviour. The MCQ consists of 27 choices between immediate and delayed rewards. The patients choose repeatedly between two hypothetical sums of money: a smaller amount now or a larger amount in the future (for example, ''Would you prefer $27 today or $50 in 21 days?"). The answers provide an estimate of the patient's discounting rate. The discounting rate parameter takes values between 0 and 1 and higher discounting rates indicate impulsivity. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
| log-transformed units on a scale | Brexpiprazole |
|---|---|
| Change From Baseline to Week 6 in Delay Discounting - Log-transformed MCQ Scores | 0.00 ± 0.24 |
The Barratt Impulsiveness Scale, Version 11 (BIS-11) is a patient-rated scale designed to assess impulsive personality traits. The BIS-11 consists of 30 items scored on a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). The total score ranges from 30 to 120 with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
| units on a scale | Brexpiprazole |
|---|---|
| Change From Baseline to Week 6 in BIS-11 Total Score | -4.85 ± 0.86 |
The Kellner Symptom Questionnaire (KSQ) is a patient-rated scale designed to assess distress using symptoms of depression, anxiety, anger-hostility, and somatization. The KSQ anger-hostility subscale score ranges from 0 to 23 with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
| units on a scale | Brexpiprazole |
|---|---|
| Change From Baseline to Week 6 in KSQ Anger-hostility Subscore | -7.72 ± 0.92 |
The Anger Attacks Questionnaire (AAQ) is a patient-rated scale designed to assess the presence of anger attacks over a period of time. The AAQ consists of 7 items. Patients are classified as having anger attacks when exhibiting the following 4 criteria: 1) irritability, 2) overreaction to minor annoyances, 3) occurrence of anger attacks (at least one of which occurred within the period), and 4) experienced 4 or more specific symptoms during at least one of the attacks. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
| participants | Brexpiprazole |
|---|---|
| no to no | 28 |
| no to yes | 5 |
| yes to no | 15 |
| yes to yes | 2 |
The 30-item Inventory of Depressive Symptomatology - Clinician-Rated (IDS-C30) is a clinician-rated scale designed to assess the severity of depressive symptoms. The IDS-C30 consists of 30 items assessing the symptoms of depression, as well as commonly associated symptoms (for example, anxiety, irritability), and topics relevant to melancholic or atypical features; the patient rates only one of the 2 items assessing appetite (decreased or increased), and only one of the 2 items assessing weight (loss or gain). Each of the items is rated on a 4-point anchored scale from 0 (least severe) to 3 (most severe). The total score is the sum of the 28 scored items, and ranges from 0 to 84, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
| units on a scale | Brexpiprazole |
|---|---|
| Change From Baseline to Week 6 in IDS-C30 Total Score | -17.81 ± 1.57 |
The Kellner Symptom Questionnaire (KSQ) is a patient-rated scale designed to assess distress using symptoms of depression, anxiety, anger-hostility, and somatization. The KSQ depression subscale score ranges from 0 to 23, with higher values indicating worse outcome . As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
| units on a scale | Brexpiprazole |
|---|---|
| Change From Baseline to Week 6 in KSQ Depression Subscore | -7.70 ± 0.93 |
The Montgomery and Åsberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
| units on a scale | Brexpiprazole |
|---|---|
| Change From Baseline to Week 6 in MADRS Total Score | -14.19 ± 1.27 |
The Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) is a patient-rated scale designed to assess cognitive and executive dysfunction including symptoms of fatigue in mood and anxiety disorders. The CPFQ consists of 7 items, each rated on a scale from 1 (greater than normal functioning) to 6 (poorer than normal functioning). The total score of the 7 items ranges from 7 to 42, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
| units on a scale | Brexpiprazole |
|---|---|
| Change From Baseline to Week 6 in CPFQ Total Score | -7.72 ± 0.97 |
The Clinical Global Impression severity of illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients). As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
| units on a scale | Brexpiprazole |
|---|---|
| Change From Baseline to Week 6 in CGI-S Score | -1.43 ± 0.16 |
The Clinical Global Impression - global improvement CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
| units on a scale | Brexpiprazole |
|---|---|
| CGI-I Score at Week 6 | 2.18 ± 0.16 |
The Kellner Symptom Questionnaire (KSQ) is a patient-rated scale designed to assess distress using symptoms of depression, anxiety, anger-hostility, and somatization. The KSQ consists of 92 items which form the basis for the four subscales: depression, anxiety, anger-hostility, and somatic; of which 68 items indicate symptoms (symptom subscales) and 24 items are antonyms of some of the symptoms and indicate well-being (well-being subscales). A "yes" or "true" response on the symptom subscales scores 1, and a "no" or "false" on the well-being subscales scores 1. The maximum score for each symptom subscale is 17, and the maximum score for each well-being subscale is 6. The score of each subscale ranges from 0 to 23 (the sum of the symptom subscale and the well-being subscale). A higher score indicates more distress. The total score ranges from 0 to 92. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
| units on a scale | Brexpiprazole |
|---|---|
| Change From Baseline to Week 6 in KSQ Total Score | -24.36 ± 2.94 |
DPDT consists of approximately 110 choices between an immediate reward or a higher delayed reward, and between an immediate reward or a higher reward that only comes with a certain probability. The tasks are scored independently of each other and do not yield a total score. There will be two derived variables from this task; a delayed discounting rate and a probability discounting rate. The delay discounting value takes values from 0 and up, a higher delay discounting value indicates greater impulsivity. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
| log transformed units on a scale | Brexpiprazole |
|---|---|
| DPDT delay score | -0.223 ± 0.349 |
| DPDT Probability Score | -0.295 ± 0.271 |
DRT consists of 60 choices between an immediate reward or a higher delayed reward. The number of impulsive choices will be a continuous variable estimated from how many immediate choices based on 60 possible. The number ranges between 0 and 60, with a higher value indicating more impulsivity. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
| units on a scale | Brexpiprazole |
|---|---|
| Change From Baseline to Week 6 in Delay Discounting - EDT DRT Score | 0.74 ± 1.97 |
The Sheehan Irritability Scale (SIS) is a patient-rated scale designed to measure irritability. The SIS consists of 7 subscales assessing irritability, frustration, edginess/impatience/overreaction, moodiness, anger with self, anger with others, and temper. The patient rates the extent to which they have suffered from these symptoms. Each subscale has verbal descriptors (not at all, mildly, moderately, markedly, and extremely) as well as numerical scores from 0 (not at all) to 10 (extremely) that provide more precise levels of the verbal descriptors. One additional question assesses number of days impaired by irritability over the period. The subscales are summarised to give the total score which ranges from 0 to 70, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
| units on a scale | Brexpiprazole |
|---|---|
| Change From Week 6 to Week 10 in SIS Total Score | 4.4 ± 2.4 |
The Sheehan Irritability Scale (SIS) is a patient-rated scale designed to measure irritability. The SIS item 1 assess how much the patient has suffered from irritability in the past week, using verbal descriptors (not at all, mildly, moderately, markedly, and extremely) as well as numerical scores from 0 (not at all) to 10 (extremely) that provide more precise levels of the verbal descriptors. The SIS item 1 ranged from 0 to 10 with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
| units on a scale | Brexpiprazole |
|---|---|
| Change From Week 6 to Week 10 in SIS Item 1 Score | 0.5 ± 0.4 |
The Monetary Choice Questionnaire (MCQ) is a patient-completed questionnaire designed to measure delay discounting, an index of impulsive behaviour. The MCQ consists of 27 choices between immediate and delayed rewards. The patients choose repeatedly between two hypothetical sums of money: a smaller amount now or a larger amount in the future (for example, ''Would you prefer $27 today or $50 in 21 days?"). The answers provide an estimate of the patient's discounting rate. The discounting rate parameter takes values between 0 and 1 and higher discounting rates indicate impulsivity. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
| log-transformed units on a scale | Brexpiprazole |
|---|---|
| Change From Week 6 to Week 10 in Delay Discounting - MCQ Scores | 0.35 ± 0.15 |
The Barratt Impulsiveness Scale, Version 11 (BIS-11) is a patient-rated scale designed to assess impulsive personality traits. The BIS-11 consists of 30 items scored on a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). The scores provide information to assess 6 first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and 3 second-order factors (motor impulsiveness, non-planning impulsiveness, and attentional impulsiveness). The total score ranges from 30 to 120 with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
| units on a scale | Brexpiprazole |
|---|---|
| Change From Week 6 to Week 10 in BIS-11 Total Score | -1.2 ± 0.9 |
The Kellner Symptom Questionnaire (KSQ) is a patient-rated scale designed to assess distress using symptoms of depression, anxiety, anger-hostility, and somatization. The KSQ anger-hostility subscale score ranges from 0 to 23 with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
| units on a scale | Brexpiprazole |
|---|---|
| Change From Week 6 to Week 10 in KSQ Anger-hostility Subscore | 1.2 ± 1.0 |
The Kellner Symptom Questionnaire (KSQ) is a patient-rated scale designed to assess distress using symptoms of depression, anxiety, anger-hostility, and somatization. The KSQ depression subscale score ranges from 0 to 23, with higher values indicating worse outcome . As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
| units on a scale | Brexpiprazole |
|---|---|
| Change From Week 6 to Week 10 in KSQ Depression Subscore | 2.1 ± 1.0 |
The Clinical Global Impression severity of illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients). As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
| units on a scale | Brexpiprazole |
|---|---|
| Change From Week 6 to Week 10 in CGI-S Score | 0.3 ± 0.1 |
The Montgomery and Åsberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome. Subgroup analyses were performed for the change from Baseline to Week 6 in MADRS total score based on the patients' BIS-11 total score at Baseline. The subgroups denoted BIS-11\_HIGH had a BIS-11 total score at Baseline ≥median at baseline and the subgroups denoted BIS-11\_LOW had a BIS-11 total score \<median at baseline. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
| units on a scale | Brexpiprazole |
|---|---|
| BIS-11_HIGH (n=27) | -14.41 ± 1.71 |
| BIS-11_LOW (n=27) | -15.45 ± 1.78 |
The subgroups denoted BIS-11\_HIGH had a BIS-11 total score at Baseline ≥median at baseline and the subgroups denoted BIS-11\_LOW had a BIS-11 total score \<median at baseline. The Clinical Global Impression severity of illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients). As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
| units on a scale | Brexpiprazole |
|---|---|
| BIS-11_HIGH (n=27) | -1.31 ± 0.21 |
| BIS-11_LOW (n=27) | -1.53 ± 0.20 |
The subgroups denoted BIS-11\_HIGH had a BIS-11 total score at Baseline ≥median at baseline and the subgroups denoted BIS-11\_LOW had a BIS-11 total score \<median at baseline. The Clinical Global Impression - global improvement CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.
| units on a scale | Brexpiprazole |
|---|---|
| BIS-11_HIGH (n=27) | 2.48 ± 0.23 |
| BIS-11_LOW (n=23) | 1.83 ± 0.20 |
Collected over Baseline to end of treatment (week 6). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Brexpiprazole | — | 0/54 (0%) | 31/54 (57.4%) |
| Event | Brexpiprazole |
|---|---|
| AkathisiaNervous system disorders | 11/54 |
| HeadacheNervous system disorders | 6/54 |
| Dry mouthGastrointestinal disorders | 4/54 |
| FatigueGeneral disorders | 4/54 |
| Increased appetiteMetabolism and nutrition disorders | 4/54 |
| InsomniaPsychiatric disorders | 4/54 |
| DiarrhoeaGastrointestinal disorders | 3/54 |
| FallInjury, poisoning and procedural complications | 3/54 |
| Weight increasedInvestigations | 3/54 |
| DizzinessNervous system disorders | 3/54 |
The all-patients-treated set (APTS) comprises all patients who took at least one dose of brexpiprazole.
| Age, Continuous(years) | Brexpiprazole |
|---|---|
| Mean | 42.41 ± 10.31 |
| Sex: Female, Male(Participants) | Brexpiprazole |
|---|---|
| Female | 34 |
| Male | 20 |
| Race (NIH/OMB)(Participants) | Brexpiprazole |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 2 |
| Black or African American | 17 |
| White | 33 |
| More than one race | 0 |
| Unknown or Not Reported | 2 |
| MADRS total score(units on a scale) | Brexpiprazole |
|---|---|
| Mean | 28.52 ± 4.51 |
| CGI-S score(units on a scale) | Brexpiprazole |
|---|---|
| Mean | 4.09 ± 0.40 |
| IDS-C30 item 6 score(units on a scale) | Brexpiprazole |
|---|---|
| Mean | 2.20 ± 0.41 |
| BIS-11 total score(units on a scale) | Brexpiprazole |
|---|---|
| Mean | 73.20 ± 12.82 |
| KSQ anger-hostility score(units on a scale) | Brexpiprazole |
|---|---|
| Mean | 14.83 ± 4.78 |
1 further baseline measures are reported on the registry.
The record gives a start of Oct 2013 and a primary completion of Jul 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Mar 2016, 1 year 8 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Brexpiprazole