Borderline Personality Disorder
Conditions
Brief summary
This study evaluates the safety and tolerability of brexpiprazole in the treatment of adults with borderline personality disorder.
Interventions
DRUGBrexpiprazole
Administered as tablets.
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Participants, who completed the last treatment visit of the previous double-blind brexpiprazole BPD trial and who, in the opinion of the investigator, could potentially benefit from administration of brexpiprazole for the treatment of BPD. * Male or female outpatients, ages 18 to 65 years, inclusive, at the time of informed consent of the previous double-blind brexpiprazole BPD trial.
Exclusion criteria
* Sexually active males or females of childbearing potential (FOCBP) who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose of IMP. Male participants must also agree not to donate sperm from trial screening/baseline through 30 days after the last dose of investigational medicinal product (IMP). * Women who are breastfeeding and/or who have a positive pregnancy test result prior to receiving IMP. * Participants who participated in a clinical trial within 90 days prior to screening/baseline (with the exception of a previous brexpiprazole double-blind BPD trial) or who participated in more than 2 clinical trials within a year prior to screening/baseline. * Participants who develop a medically significant abnormality.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and as Per Severity | Signing of ICF up to 30 days post last dose of study drug (up to approximately 16 weeks) | An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant administered an IMP and which does not necessarily have a causal relationship with this treatment. TEAEs are defined as AEs with an onset date on or after the start of open-label treatment. The severity of AEs was graded on a 3-point scale: 1=Mild (Discomfort noticed, but no disruption to daily activity), 2=Moderate (Discomfort sufficient to reduce or affect normal daily activity), and 3=Severe (Inability to work or perform normal daily activity). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Potentially Clinically Significant Vital Sign Abnormalities | Screening up to Week 12 | Potentially clinically significant vital sign abnormalities included: Heart rate standing in bpm (\<50 bpm and decrease \>=15 bpm, \>120 bpm and increase \>=15 bpm); Weight in kilograms (kgs) (decrease \>=7%, increase \>=7%). |
| Number of Participants With Potentially Clinically Significant Laboratory Abnormalities | Screening up to Week 12 | Potentially clinically significant laboratory abnormalities included serum chemistry: Prolactin \>upper limit of normal (ULN) (nanograms per millilitre \[ng/ml\] in males and females), fasting glucose ≥100 (milligrams per decilitre \[mg/dl\]), fasting high-density lipoprotein (HDL) cholesterol \<40 (men)/ \<50 (women) (mg/dl), fasting low-density lipoprotein (LDL) cholesterol ≥160 (mg/dl), fasting cholesterol ≥240 (mg/dl), fasting triglycerides ≥150 (mg/dl); Creatine phosphokinase (CPK)/renal: Creatine kinase \>3xULN (units per litre \[U/l\]), creatinine ≥2.0 (mg/dl), urea nitrogen ≥30 (mg/dl). |
| Change From Baseline in Simpson-Angus Scale (SAS) Total Score | Baseline and Week 12 | The SAS scale is used to evaluate extrapyramidal symptoms (EPS) and consists of a list of 10 symptoms of Parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia). Each item is rated on a 5-point scale, with a score range of 0 (absence of symptoms) to 4 (severe condition). The SAS total score is the sum of the scores for all 10 items, possible total score is 0 to 40. Negative change from baseline indicates less symptoms. |
| Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities | Screening up to Week 12 | Potentially clinically significant ECG abnormalities included rate: Bradycardia (vent \<=50 beats per minute \[bpm\] and decrease \>=15 bpm); Rhythm: Sinus bradycardia (\<=50 bpm and decrease \>=15 bpm), absence during baseline and presence of ventricular premature beat post baseline; ST/T morphology: Absence at baseline and presence of symmetrical T-wave inversion post baseline. |
| Change From Baseline in Barnes Akathisia Rating Scale (BARS): Global Clinical Assessment of Akathisia Score | Baseline and Week 12 | The BARS consists of 4 items related to akathisia: Objective observation of akathisia by the investigator, subjective feelings of restlessness by the participant, subjective distress due to akathisia, and global clinical assessment of akathisia. The fourth item, global clinical evaluation was rated on a 6-point scale, with a score range of 0 (absence of symptoms) to 5 (severe akathisia). Lower scores indicate less symptoms and negative change from baseline indicate less symptoms. |
| Number of Participants With Suicidal Ideation and Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline up to Week 12 | C-SSRS was used to assess the suicidality of participants during the study. The assessment included yes or no responses for 5 questions, each related to suicidal ideation (wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods, active suicidal ideation with some intent, active suicidal ideation with specific plan) and suicidal behavior (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, suicide). Numeric ratings were provided for suicidal ideation: Score range of 1 (wish to be dead) to 5 (active suicidal ideation with specific plan and intent), higher total scores indicate more suicidal ideation; Suicidal behavior: Score range of 0 (no suicidal behavior) to 4 (actual suicide attempt), higher total scores indicate more suicidal behavior. |
| Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score | Baseline and Week 12 | The AIMS scale consists of 10 items describing symptoms of dyskinesia: Facial and oral movements (items 1-4), extremity movements (items 5 and 6), and trunk movements (item 7), dyskinesias (items 8-10). Each item is rated on a 5-point scale, with a score range of 0 (absence of symptoms) (for item 10, no awareness) to 4 (severe condition) (for item 10, awareness, severe distress). AIMS total score is the sum of the ratings for the first seven items with the possible total scores of 0 to 28. Negative change from baseline indicates less symptoms. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled at 55 investigational sites in Spain, Ukraine, and the United States (US) from 13 January 2020 to 22 September 2021.
Pre-assignment details
A total of 203 participants with borderline personality disorder (BPD), who completed the previous double-blind trial (NCT04100096) were screened, out of which 201 participants were enrolled in this study. Of the enrolled participants, 90 received 2 to 3 milligrams per day (mg/day) brexpiprazole and 111 received brexpiprazole matching placebo in the previous double-blind trial.
Participants by arm
| Arm | Count |
|---|---|
| Prior Brexpiprazole 2-3 mg/Day Participants who received blinded brexpiprazole 2 to 3 mg/day in the previous double-blind trial (NCT04100096), received open-label brexpiprazole 2 to 3 mg/day tablets, orally for up to 12 weeks. | 90 |
| Prior Placebo Participants who received blinded brexpiprazole matching placebo in the previous double-blind trial (NCT04100096), received open-label brexpiprazole 2 to 3 mg/day tablets, orally for up to 12 weeks. | 111 |
| Total | 201 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 8 |
| Overall Study | Lost to Follow-up | 7 | 3 |
| Overall Study | Other: Not Related to Covid-19 | 3 | 0 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 7 | 8 |
Baseline characteristics
| Characteristic | Prior Brexpiprazole 2-3 mg/Day | Prior Placebo | Total |
|---|---|---|---|
| Age, Continuous | 33.6 years STANDARD_DEVIATION 10.5 | 32.0 years STANDARD_DEVIATION 10.6 | 32.7 years STANDARD_DEVIATION 10.6 |
| Race/Ethnicity, Customized Ethnicity Hispanic or Latino | 15 Participants | 17 Participants | 32 Participants |
| Race/Ethnicity, Customized Ethnicity Not Hispanic or Latino | 75 Participants | 93 Participants | 168 Participants |
| Race/Ethnicity, Customized Ethnicity Other | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Asian | 4 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Race Black or African American | 7 Participants | 19 Participants | 26 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Other | 5 Participants | 2 Participants | 7 Participants |
| Race/Ethnicity, Customized Race White | 72 Participants | 89 Participants | 161 Participants |
| Sex: Female, Male Female | 71 Participants | 92 Participants | 163 Participants |
| Sex: Female, Male Male | 19 Participants | 19 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 90 | 0 / 111 |
| other Total, other adverse events | 8 / 88 | 31 / 111 |
| serious Total, serious adverse events | 1 / 88 | 2 / 111 |
Outcome results
Primary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and as Per Severity
An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant administered an IMP and which does not necessarily have a causal relationship with this treatment. TEAEs are defined as AEs with an onset date on or after the start of open-label treatment. The severity of AEs was graded on a 3-point scale: 1=Mild (Discomfort noticed, but no disruption to daily activity), 2=Moderate (Discomfort sufficient to reduce or affect normal daily activity), and 3=Severe (Inability to work or perform normal daily activity).
Time frame: Signing of ICF up to 30 days post last dose of study drug (up to approximately 16 weeks)
Population: Safety sample included all participants who received at least 1 dose of IMP.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Prior Brexpiprazole 2-3 mg/Day | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and as Per Severity | TEAEs | 30 Participants |
| Prior Brexpiprazole 2-3 mg/Day | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and as Per Severity | Mild TEAEs | 14 Participants |
| Prior Brexpiprazole 2-3 mg/Day | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and as Per Severity | Moderate TEAEs | 19 Participants |
| Prior Brexpiprazole 2-3 mg/Day | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and as Per Severity | Severe TEAEs | 3 Participants |
| Prior Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and as Per Severity | Severe TEAEs | 4 Participants |
| Prior Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and as Per Severity | TEAEs | 56 Participants |
| Prior Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and as Per Severity | Moderate TEAEs | 30 Participants |
| Prior Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and as Per Severity | Mild TEAEs | 37 Participants |
Secondary
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score
The AIMS scale consists of 10 items describing symptoms of dyskinesia: Facial and oral movements (items 1-4), extremity movements (items 5 and 6), and trunk movements (item 7), dyskinesias (items 8-10). Each item is rated on a 5-point scale, with a score range of 0 (absence of symptoms) (for item 10, no awareness) to 4 (severe condition) (for item 10, awareness, severe distress). AIMS total score is the sum of the ratings for the first seven items with the possible total scores of 0 to 28. Negative change from baseline indicates less symptoms.
Time frame: Baseline and Week 12
Population: Safety sample included all participants who received at least 1 dose of IMP. Overall number analyzed is the number of participants with data available for analyses. 'Number Analyzed' signifies number of participants with available data for this outcome measure at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prior Brexpiprazole 2-3 mg/Day | Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score | Baseline | 0.0 score on a scale | Standard Deviation 0.1 |
| Prior Brexpiprazole 2-3 mg/Day | Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score | Change From Baseline at Week 12 | 0.0 score on a scale | Standard Deviation 0.2 |
| Prior Placebo | Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score | Baseline | 0.1 score on a scale | Standard Deviation 0.8 |
| Prior Placebo | Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score | Change From Baseline at Week 12 | -0.1 score on a scale | Standard Deviation 0.9 |
Secondary
Change From Baseline in Barnes Akathisia Rating Scale (BARS): Global Clinical Assessment of Akathisia Score
The BARS consists of 4 items related to akathisia: Objective observation of akathisia by the investigator, subjective feelings of restlessness by the participant, subjective distress due to akathisia, and global clinical assessment of akathisia. The fourth item, global clinical evaluation was rated on a 6-point scale, with a score range of 0 (absence of symptoms) to 5 (severe akathisia). Lower scores indicate less symptoms and negative change from baseline indicate less symptoms.
Time frame: Baseline and Week 12
Population: Safety sample included all participants who received at least 1 dose of IMP. Overall number analyzed is the number of participants with data available for analyses. 'Number Analyzed' signifies number of participants with available data for this outcome measure at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prior Brexpiprazole 2-3 mg/Day | Change From Baseline in Barnes Akathisia Rating Scale (BARS): Global Clinical Assessment of Akathisia Score | Baseline | 0.1 score on a scale | Standard Deviation 0.3 |
| Prior Brexpiprazole 2-3 mg/Day | Change From Baseline in Barnes Akathisia Rating Scale (BARS): Global Clinical Assessment of Akathisia Score | Change From Baseline at Week 12 | -0.1 score on a scale | Standard Deviation 0.3 |
| Prior Placebo | Change From Baseline in Barnes Akathisia Rating Scale (BARS): Global Clinical Assessment of Akathisia Score | Baseline | 0.1 score on a scale | Standard Deviation 0.3 |
| Prior Placebo | Change From Baseline in Barnes Akathisia Rating Scale (BARS): Global Clinical Assessment of Akathisia Score | Change From Baseline at Week 12 | -0.0 score on a scale | Standard Deviation 0.5 |
Secondary
Change From Baseline in Simpson-Angus Scale (SAS) Total Score
The SAS scale is used to evaluate extrapyramidal symptoms (EPS) and consists of a list of 10 symptoms of Parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia). Each item is rated on a 5-point scale, with a score range of 0 (absence of symptoms) to 4 (severe condition). The SAS total score is the sum of the scores for all 10 items, possible total score is 0 to 40. Negative change from baseline indicates less symptoms.
Time frame: Baseline and Week 12
Population: Safety sample included all participants who received at least 1 dose of IMP. Overall number analyzed is the number of participants with data available for analyses. 'Number Analyzed' signifies number of participants with available data for this outcome measure at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prior Brexpiprazole 2-3 mg/Day | Change From Baseline in Simpson-Angus Scale (SAS) Total Score | Baseline | 0.2 score on a scale | Standard Deviation 0.9 |
| Prior Brexpiprazole 2-3 mg/Day | Change From Baseline in Simpson-Angus Scale (SAS) Total Score | Change From Baseline at Week 12 | -0.1 score on a scale | Standard Deviation 0.7 |
| Prior Placebo | Change From Baseline in Simpson-Angus Scale (SAS) Total Score | Baseline | 0.1 score on a scale | Standard Deviation 0.6 |
| Prior Placebo | Change From Baseline in Simpson-Angus Scale (SAS) Total Score | Change From Baseline at Week 12 | 0.0 score on a scale | Standard Deviation 0.6 |
Secondary
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities
Potentially clinically significant ECG abnormalities included rate: Bradycardia (vent \<=50 beats per minute \[bpm\] and decrease \>=15 bpm); Rhythm: Sinus bradycardia (\<=50 bpm and decrease \>=15 bpm), absence during baseline and presence of ventricular premature beat post baseline; ST/T morphology: Absence at baseline and presence of symmetrical T-wave inversion post baseline.
Time frame: Screening up to Week 12
Population: Safety sample included all participants who received at least 1 dose of IMP. 'Number Analyzed' signifies number of participants with available data for the specified measurement.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Prior Brexpiprazole 2-3 mg/Day | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities | Bradycardia | 0 Participants |
| Prior Brexpiprazole 2-3 mg/Day | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities | Sinus Bradycardia | 0 Participants |
| Prior Brexpiprazole 2-3 mg/Day | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities | Ventricular Premature Beat | 0 Participants |
| Prior Brexpiprazole 2-3 mg/Day | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities | Symmetrical T-Wave Inversion | 0 Participants |
| Prior Placebo | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities | Symmetrical T-Wave Inversion | 1 Participants |
| Prior Placebo | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities | Bradycardia | 1 Participants |
| Prior Placebo | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities | Ventricular Premature Beat | 1 Participants |
| Prior Placebo | Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities | Sinus Bradycardia | 1 Participants |
Secondary
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities
Potentially clinically significant laboratory abnormalities included serum chemistry: Prolactin \>upper limit of normal (ULN) (nanograms per millilitre \[ng/ml\] in males and females), fasting glucose ≥100 (milligrams per decilitre \[mg/dl\]), fasting high-density lipoprotein (HDL) cholesterol \<40 (men)/ \<50 (women) (mg/dl), fasting low-density lipoprotein (LDL) cholesterol ≥160 (mg/dl), fasting cholesterol ≥240 (mg/dl), fasting triglycerides ≥150 (mg/dl); Creatine phosphokinase (CPK)/renal: Creatine kinase \>3xULN (units per litre \[U/l\]), creatinine ≥2.0 (mg/dl), urea nitrogen ≥30 (mg/dl).
Time frame: Screening up to Week 12
Population: Safety sample included all participants who received at least 1 dose of IMP. 'Number Analyzed' signifies number of participants with available data for the specified measurement.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Prior Brexpiprazole 2-3 mg/Day | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities | Prolactin (ng/ml)-Males | 1 Participants |
| Prior Brexpiprazole 2-3 mg/Day | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities | Glucose, Fasting (mg/dL) | 13 Participants |
| Prior Brexpiprazole 2-3 mg/Day | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities | HDL Cholesterol, Fasting (mg/dL) | 22 Participants |
| Prior Brexpiprazole 2-3 mg/Day | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities | LDL Cholesterol, Fasting (mg/dL) | 2 Participants |
| Prior Brexpiprazole 2-3 mg/Day | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities | Cholesterol, Fasting (mg/dL) | 2 Participants |
| Prior Brexpiprazole 2-3 mg/Day | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities | Triglycerides, Fasting (mg/dL) | 13 Participants |
| Prior Placebo | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities | Cholesterol, Fasting (mg/dL) | 7 Participants |
| Prior Placebo | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities | Prolactin (ng/ml)-Males | 0 Participants |
| Prior Placebo | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities | LDL Cholesterol, Fasting (mg/dL) | 3 Participants |
| Prior Placebo | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities | Glucose, Fasting (mg/dL) | 11 Participants |
| Prior Placebo | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities | Triglycerides, Fasting (mg/dL) | 13 Participants |
| Prior Placebo | Number of Participants With Potentially Clinically Significant Laboratory Abnormalities | HDL Cholesterol, Fasting (mg/dL) | 19 Participants |
Secondary
Number of Participants With Potentially Clinically Significant Vital Sign Abnormalities
Potentially clinically significant vital sign abnormalities included: Heart rate standing in bpm (\<50 bpm and decrease \>=15 bpm, \>120 bpm and increase \>=15 bpm); Weight in kilograms (kgs) (decrease \>=7%, increase \>=7%).
Time frame: Screening up to Week 12
Population: Safety sample included all participants who received at least 1 dose of IMP.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Prior Brexpiprazole 2-3 mg/Day | Number of Participants With Potentially Clinically Significant Vital Sign Abnormalities | Heart Rate Standing | 3 Participants |
| Prior Brexpiprazole 2-3 mg/Day | Number of Participants With Potentially Clinically Significant Vital Sign Abnormalities | Weight Decreased | 7 Participants |
| Prior Brexpiprazole 2-3 mg/Day | Number of Participants With Potentially Clinically Significant Vital Sign Abnormalities | Weight Increased | 9 Participants |
| Prior Placebo | Number of Participants With Potentially Clinically Significant Vital Sign Abnormalities | Heart Rate Standing | 1 Participants |
| Prior Placebo | Number of Participants With Potentially Clinically Significant Vital Sign Abnormalities | Weight Decreased | 4 Participants |
| Prior Placebo | Number of Participants With Potentially Clinically Significant Vital Sign Abnormalities | Weight Increased | 26 Participants |
Secondary
Number of Participants With Suicidal Ideation and Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
C-SSRS was used to assess the suicidality of participants during the study. The assessment included yes or no responses for 5 questions, each related to suicidal ideation (wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods, active suicidal ideation with some intent, active suicidal ideation with specific plan) and suicidal behavior (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, suicide). Numeric ratings were provided for suicidal ideation: Score range of 1 (wish to be dead) to 5 (active suicidal ideation with specific plan and intent), higher total scores indicate more suicidal ideation; Suicidal behavior: Score range of 0 (no suicidal behavior) to 4 (actual suicide attempt), higher total scores indicate more suicidal behavior.
Time frame: Baseline up to Week 12
Population: Safety sample included all participants who received at least 1 dose of IMP.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Prior Brexpiprazole 2-3 mg/Day | Number of Participants With Suicidal Ideation and Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal Ideation | 28 Participants |
| Prior Brexpiprazole 2-3 mg/Day | Number of Participants With Suicidal Ideation and Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal Behavior | 0 Participants |
| Prior Placebo | Number of Participants With Suicidal Ideation and Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal Ideation | 28 Participants |
| Prior Placebo | Number of Participants With Suicidal Ideation and Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal Behavior | 2 Participants |