Trial Outcomes & Findings for A Trial of Multiple-doses of Aripiprazole in Adults With Schizophrenia or Bipolar 1 Disorder (NCT NCT04030143)

Last Updated: 2023-11-18

Results Overview

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical trial participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. A TEAE is defined as an AE that started after investigational medicinal product (IMP) treatment; or if the event was continuous from baseline and was serious, IMP-related, or resulted in death, discontinuation, interruption, or reduction of the IMP.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

266 participants

Primary outcome timeframe

From first dose of study drug up to 56 days (2M LAI 960 mg) or 28 days (IM depot 400 mg) post last dose of study drug (up to approximately 11 months)

Results posted on

2023-11-18

Participant Flow

Participants were enrolled in the study at 16 investigational sites in the United States from 01 August 2019 to 08 July 2020.

Participant milestones

Participant milestones
Measure	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder Participants with schizophrenia or bipolar I disorder received aripiprazole 2 month (2M) long-acting injection (LAI) 960 milligrams (mg) for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder Participants with schizophrenia or bipolar I disorder received aripiprazole intra-muscularly (IM) 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Overall Study STARTED	132	134
Overall Study Safety Sample	132	134
Overall Study Efficacy Sample	132	134
Overall Study COMPLETED	102	92
Overall Study NOT COMPLETED	30	42

Reasons for withdrawal

Reasons for withdrawal
Measure	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder Participants with schizophrenia or bipolar I disorder received aripiprazole 2 month (2M) long-acting injection (LAI) 960 milligrams (mg) for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder Participants with schizophrenia or bipolar I disorder received aripiprazole intra-muscularly (IM) 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Overall Study Adverse Event	5	10
Overall Study Lost to Follow-up	3	7
Overall Study Protocol Deviation	2	2
Overall Study Withdrawal by Subject	16	18
Overall Study Physician Decision	1	1
Overall Study Due to Covid-19	2	3
Overall Study Not Due to Covid-19	1	1

Baseline Characteristics

A Trial of Multiple-doses of Aripiprazole in Adults With Schizophrenia or Bipolar 1 Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder n=132 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder n=134 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.	Total n=266 Participants Total of all reporting groups
Age, Continuous	47.8 years STANDARD_DEVIATION 10.8 • n=5 Participants	46.8 years STANDARD_DEVIATION 11.7 • n=7 Participants	47.3 years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants	48 Participants n=7 Participants	90 Participants n=5 Participants
Sex: Female, Male Male	90 Participants n=5 Participants	86 Participants n=7 Participants	176 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	119 Participants n=5 Participants	122 Participants n=7 Participants	241 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	29 Participants n=5 Participants	33 Participants n=7 Participants	62 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black or African American	99 Participants n=5 Participants	95 Participants n=7 Participants	194 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: From first dose of study drug up to 56 days (2M LAI 960 mg) or 28 days (IM depot 400 mg) post last dose of study drug (up to approximately 11 months)

Population: Safety sample included all randomized participants who received at least 1 dose of aripiprazole injection, regardless of any protocol violation.

Outcome measures

Outcome measures
Measure	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder n=132 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder n=134 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Number of Participants With One or More Treatment-Emergent Adverse Events (TEAEs)	94 Participants	95 Participants

PRIMARY outcome

Timeframe: From first dose of study drug up to Day 225

Population: Safety sample included all randomized participants who receive at least 1 dose of aripiprazole injection, regardless of any protocol violation. Overall number analyzed is the number of participants with data available for outcome measure analysis. 'Number Analyzed' signifies number of participants with data available for analysis of specified parameter.

Potentially clinically significant vital sign abnormalities included: heart rate supine (high: \>120 beats per minute \[BPM\] and increase \>=15 BPM; low: \<50 BPM and decrease \>=15 BPM), systolic blood pressure supine (high \>180 (millimetres of mercury \[mmHg\] and increase \>=20 mmHg); low: \<90 mmHg and decrease \>=20 mmHg), diastolic blood pressure supine (high: \>105 mmHg and increase \>=15 mmHg; low: \<50 mmHg and decrease \>=15 mmHg), heart rate standing (high: \>120 BPM and increase \>=15 BPM), systolic blood pressure standing (high: \>180 mmHg and increase \>= 20 mmHg; low: \<90 mmHg and decrease \>=20 mmHg), diastolic blood pressure standing (high: \>105 mmHg and increase \>=15 mmHg), weight in kilograms (kg) (high: increase \>=7%; low: decrease \>=7%), temperature (high: \>=37.8 degree celsius \[°C\] and increase \>=1.1°C), orthostatic hypotension (low: \>=20 mmHg decrease in systolic blood pressure and \>=25 BPM increase in heart rate from supine to standing.

Outcome measures

Outcome measures
Measure	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder n=131 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder n=133 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities Heart Rate Supine: Low	0 Participants	1 Participants
Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities Heart Rate Supine: High	2 Participants	1 Participants
Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities Systolic Blood Pressure Supine: Low	1 Participants	2 Participants
Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities Systolic Blood Pressure Supine: High	0 Participants	1 Participants
Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities Diastolic Blood Pressure Supine: Low	1 Participants	1 Participants
Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities Diastolic Blood Pressure Supine: High	1 Participants	1 Participants
Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities Heart Rate Standing: High	4 Participants	6 Participants
Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities Systolic Blood Pressure Standing: Low	1 Participants	4 Participants
Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities Systolic Blood Pressure Standing: High	0 Participants	2 Participants
Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities Diastolic Blood Pressure Standing: High	2 Participants	3 Participants
Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities Weight: Low	12 Participants	11 Participants
Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities Weight: High	52 Participants	54 Participants
Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities Temperature: High	4 Participants	4 Participants
Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities Orthostatic Hypotension: Low	2 Participants	2 Participants

PRIMARY outcome

Timeframe: From first dose of study drug up to Day 225

Potentially clinically significant ECG abnormalities included rate: bradycardia (vent \<=50 BPM\] and decrease \>=15 BPM); rhythm: sinus bradycardia (\<= 50 BPM and decrease \>= 15 BPM and no current diagnosis of atrial fibrillation, atrial flutter, or other rhythm abnormality); supraventricular premature beat (not present at baseline and present post baseline); ventricular premature beat (not present at baseline and present post baseline); conduction: right bundle branch block (not present at baseline and present post baseline); ST/T morphology: myocardial ischemia and symmetrical T-wave inversion (not present at baseline and present post baseline), QTcB, QTcF, and QTcN (\>=450 milliseconds \[msec\] and \>= 10% increase).

Outcome measures

Outcome measures
Measure	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder n=130 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder n=131 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities Bradycardia	0 Participants	2 Participants
Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities Sinus Bradycardia	0 Participants	2 Participants
Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities Supraventricular Premature Beat	13 Participants	10 Participants
Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities Ventricular Premature Beat	17 Participants	12 Participants
Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities Right Bundle Branch Block	1 Participants	0 Participants
Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities Myocardial Ischemia	3 Participants	7 Participants
Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities Symmetrical T-Wave Inversion	12 Participants	12 Participants
Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities QTcB	1 Participants	1 Participants
Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities QTcF	0 Participants	1 Participants
Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities QTcN	0 Participants	1 Participants

PRIMARY outcome

Timeframe: From first dose of study drug up to Day 225

Population: Safety sample included all randomized participants who received at least 1 dose of aripiprazole injection, regardless of any protocol violation. Overall number analyzed is the number of participants with data available for outcome measure analysis. 'Number Analyzed' signifies number of participants with data available for analysis of specified parameter.

Potentially clinically relevant laboratory abnormalities included: In units per liter \[U/L\] (alanine aminotransferase: male\[M\]/female\[F\] \>=3 x upper limit of normal (ULN); aspartate aminotransferase: M/F \>= 3 x ULN; creatine kinase: M/F \>= 3 x ULN); in milligrams per deciliter (mg/dL) (creatinine: M/F \>= 2.0; glucose: M/F \>= 200; urate: M \>=10.5, F \>=8.5); potassium \[milliequivalents per liter (mEq/L)\]: M/F \>=5.5, in percentage (%) (eosinophils/leukocytes: M/F\>=10%, hematocrit: M\<=37%/F\<=32% and 3 point decrease from baseline); hemoglobin (grams per deciliter \[g/dL\]): M\<=11.5/F\<=9.5; leukocytes \[10\^9 per liter (/L)\]: M/F\<=2.8 x 10\^3 per microliters (/uL); platelets (10\^9/L): M/F\>=700 x 10\^3/uL; glucose, urine and protein, urine: increase of \>=2 units; and prolactin (nanograms per milliliter \[ng/mL\]: M/F \> 1 x ULN.

Outcome measures

Outcome measures
Measure	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder n=129 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder n=126 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities High Alanine Aminotransferase (U/L)	1 Participants	2 Participants
Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities High Aspartate Aminotransferase (U/L)	0 Participants	2 Participants
Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities High Creatine Kinase (U/L)	12 Participants	1 Participants
Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities High Creatinine (mg/dL)	2 Participants	1 Participants
Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities High Glucose (mg/dL)	7 Participants	3 Participants
Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities High Potassium (mEq/L)	5 Participants	4 Participants
Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities High Urate (mg/dL)	2 Participants	0 Participants
Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities High Eosinophils/Leukocytes (%)	2 Participants	0 Participants
Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities Low Hematocrit (%)	7 Participants	8 Participants
Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities Low Hemoglobin (g/dL)	4 Participants	9 Participants
Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities Low Leukocytes (10^9/L)	0 Participants	3 Participants
Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities High Platelets (10^9/L)	0 Participants	1 Participants
Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities High Glucose, Urine	5 Participants	6 Participants
Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities High Protein, Urine	1 Participants	2 Participants
Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities High Prolactin (ng/mL)	2 Participants	4 Participants

PRIMARY outcome

Timeframe: Baseline, Week 32

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 of 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.

Outcome measures

Outcome measures
Measure	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder n=132 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder n=134 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Mean Change From Baseline in Simpson-Angus Neurologic Rating Scale (SAS) Total Score Baseline	0.2 score on a scale Standard Deviation 0.6	0.2 score on a scale Standard Deviation 0.4
Mean Change From Baseline in Simpson-Angus Neurologic Rating Scale (SAS) Total Score Change From Baseline at Week 32	-0.0 score on a scale Standard Deviation 0.7	0.1 score on a scale Standard Deviation 0.6

PRIMARY outcome

Timeframe: Baseline, Week 32

The AIMS assessment consists of 10 items describing symptoms of dyskinesia. Facial and oral movements (items 1 through 4), extremity movements (items 5 and 6), and trunk movements (item 7), dyskinesias (items 8 through 10). Each item is rated on a 5-point scale, with a score of 0 representing absence of symptoms (for item 10, no awareness), and a score of 4 indicating a severe condition (for item 10, aware/severe distress). AIMS movement 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.

Outcome measures

Outcome measures
Measure	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder n=132 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder n=134 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Score Change from Baseline at Week 32	0.0 score on a scale Standard Deviation 0.5	-0.1 score on a scale Standard Deviation 0.6
Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Score Baseline	0.1 score on a scale Standard Deviation 1.0	0.1 score on a scale Standard Deviation 0.7

PRIMARY outcome

Timeframe: Baseline, Week 32

The BARS consists of 4 items related to akathisia: objective observation of akathisia by the investigator, subjective feelings of restlessness by the participant, participant distress due to akathisia, and global evaluation of akathisia. The first 3 items are rated on a 4-point scale, with a score of 0 representing absence of symptoms and a score of 3 representing a severe condition. The global clinical evaluation is made on a 6-point scale, with 0 representing absence of symptoms and a score of 5 representing severe akathisia. Total BARS score ranges from 0 to 14 where lower scores indicate less symptoms and negative change from baseline indicate less symptoms.

Outcome measures

Outcome measures
Measure	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder n=132 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder n=134 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Mean Change From Baseline in Barnes Akathisia Rating Score (BARS) Global Score Baseline	0.1 score on a scale Standard Deviation 0.3	0.1 score on a scale Standard Deviation 0.3
Mean Change From Baseline in Barnes Akathisia Rating Score (BARS) Global Score Change from Baseline at Week 32	0.1 score on a scale Standard Deviation 0.6	0.1 score on a scale Standard Deviation 0.4

PRIMARY outcome

Timeframe: Day 1 (First injection) to Day 169 (Last injection)

Injection-site pain was evaluated by mean VAS scores as reported by the participant after each injection at visits where an injection occurred. The last injection was the final injection for any given participant. Ratings ranged from 0 (no pain) to 100 (unbearably painful).

Outcome measures

Outcome measures
Measure	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder n=132 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Visual Analog Scale (VAS) Scores for Pain Perception of Aripiprazole 2M LAI 960 mg Last Injection: Post dose	1.4 score on a scale Standard Deviation 3.98	—
Visual Analog Scale (VAS) Scores for Pain Perception of Aripiprazole 2M LAI 960 mg First Injection: Predose	1.0 score on a scale Standard Deviation 1.29	—
Visual Analog Scale (VAS) Scores for Pain Perception of Aripiprazole 2M LAI 960 mg First Injection: Post dose	3.7 score on a scale Standard Deviation 9.09	—
Visual Analog Scale (VAS) Scores for Pain Perception of Aripiprazole 2M LAI 960 mg Second Injection: Predose	1.0 score on a scale Standard Deviation 2.32	—
Visual Analog Scale (VAS) Scores for Pain Perception of Aripiprazole 2M LAI 960 mg Second Injection: Post dose	1.4 score on a scale Standard Deviation 2.78	—
Visual Analog Scale (VAS) Scores for Pain Perception of Aripiprazole 2M LAI 960 mg Third Injection: Predose	1.0 score on a scale Standard Deviation 2.58	—
Visual Analog Scale (VAS) Scores for Pain Perception of Aripiprazole 2M LAI 960 mg Third Injection: Post dose	2.0 score on a scale Standard Deviation 6.01	—
Visual Analog Scale (VAS) Scores for Pain Perception of Aripiprazole 2M LAI 960 mg Fourth Injection: Predose	0.8 score on a scale Standard Deviation 1.02	—
Visual Analog Scale (VAS) Scores for Pain Perception of Aripiprazole 2M LAI 960 mg Fourth Injection: Post dose	1.4 score on a scale Standard Deviation 4.38	—
Visual Analog Scale (VAS) Scores for Pain Perception of Aripiprazole 2M LAI 960 mg Last Injection: Predose	0.8 score on a scale Standard Deviation 1.03	—

PRIMARY outcome

Timeframe: Day 1 (First injection) to Day 197 (Last injection)

Population: Safety sample included all randomized participants who receive at least 1 dose of aripiprazole injection, regardless of any protocol violation. 'Number Analyzed' signifies number of participants with available data for this outcome measure at the specified timepoint. Participants whose VAS scores were analyzed for pain perception, are reported in this outcome measure, and may differ from participants who were assessed by Investigator for pain on 4-point scale.

Outcome measures

Outcome measures
Measure	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder n=134 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
VAS Scores for Pain Perception of Aripiprazole IM Depot 400 mg Third Injection: Predose	0.8 score on a scale Standard Deviation 1.10	—
VAS Scores for Pain Perception of Aripiprazole IM Depot 400 mg Third Injection: Post dose	1.2 score on a scale Standard Deviation 2.09	—
VAS Scores for Pain Perception of Aripiprazole IM Depot 400 mg Eighth Injection: Post dose	0.8 score on a scale Standard Deviation 0.85	—
VAS Scores for Pain Perception of Aripiprazole IM Depot 400 mg Fourth Injection: Post dose	1.1 score on a scale Standard Deviation 2.39	—
VAS Scores for Pain Perception of Aripiprazole IM Depot 400 mg Fifth Injection: Predose	0.7 score on a scale Standard Deviation 0.82	—
VAS Scores for Pain Perception of Aripiprazole IM Depot 400 mg Fifth Injection: Post dose	0.8 score on a scale Standard Deviation 1.12	—
VAS Scores for Pain Perception of Aripiprazole IM Depot 400 mg Sixth Injection: Predose	0.8 score on a scale Standard Deviation 1.11	—
VAS Scores for Pain Perception of Aripiprazole IM Depot 400 mg Sixth Injection: Post dose	0.8 score on a scale Standard Deviation 1.20	—
VAS Scores for Pain Perception of Aripiprazole IM Depot 400 mg Seventh Injection: Predose	0.6 score on a scale Standard Deviation 0.77	—
VAS Scores for Pain Perception of Aripiprazole IM Depot 400 mg Seventh Injection: Post dose	1.0 score on a scale Standard Deviation 2.30	—
VAS Scores for Pain Perception of Aripiprazole IM Depot 400 mg Eighth Injection: Predose	0.6 score on a scale Standard Deviation 0.69	—
VAS Scores for Pain Perception of Aripiprazole IM Depot 400 mg Last Injection: Predose	0.9 score on a scale Standard Deviation 1.00	—
VAS Scores for Pain Perception of Aripiprazole IM Depot 400 mg Last Injection: Post dose	1.3 score on a scale Standard Deviation 2.62	—
VAS Scores for Pain Perception of Aripiprazole IM Depot 400 mg First Injection: Predose	1.6 score on a scale Standard Deviation 2.37	—
VAS Scores for Pain Perception of Aripiprazole IM Depot 400 mg First Injection: Post dose	3.0 score on a scale Standard Deviation 5.28	—
VAS Scores for Pain Perception of Aripiprazole IM Depot 400 mg Second Injection: Predose	1.5 score on a scale Standard Deviation 2.66	—
VAS Scores for Pain Perception of Aripiprazole IM Depot 400 mg Second Injection: Post dose	1.6 score on a scale Standard Deviation 3.09	—
VAS Scores for Pain Perception of Aripiprazole IM Depot 400 mg Fourth Injection: Predose	0.7 score on a scale Standard Deviation 0.79	—

PRIMARY outcome

Timeframe: Day 1 (First injection) to Day 169 (Last injection)

Population: Safety sample included all randomized participants who received at least 1 dose of aripiprazole injection, regardless of any protocol violation. Overall number analyzed is the number of participants with data available for outcome measure analysis. 'Number Analyzed' signifies number of participants with available data for this outcome measure at the specified timepoint.

Injection-site reactions were assessed by the investigator (or qualified designee) and the participant. Investigators rated localized pain, redness, swelling, and induration at the most recent injection site using a 4-point categorical scale (absent, mild, moderate, severe). The participant indicated the degree of pain at the most recent injection site using a VAS instrument. Ratings included were: 0 = absent, 1 = mild, 2 = moderate, 3 = severe. The last injection was the final injection for any given participant.

Outcome measures

Outcome measures
Measure	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder n=131 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Number of Participants With Injection Site Evaluations (Pain, Redness, Swelling, Induration) Measured by Investigator Rating After Aripiprazole 2M LAI 960 mg Injection Fourth Injection: Mild Pain	5 Participants	—
Number of Participants With Injection Site Evaluations (Pain, Redness, Swelling, Induration) Measured by Investigator Rating After Aripiprazole 2M LAI 960 mg Injection First Injection: Mild Pain	11 Participants	—
Number of Participants With Injection Site Evaluations (Pain, Redness, Swelling, Induration) Measured by Investigator Rating After Aripiprazole 2M LAI 960 mg Injection Second Injection: Mild Pain	2 Participants	—
Number of Participants With Injection Site Evaluations (Pain, Redness, Swelling, Induration) Measured by Investigator Rating After Aripiprazole 2M LAI 960 mg Injection Third Injection: Mild Pain	5 Participants	—
Number of Participants With Injection Site Evaluations (Pain, Redness, Swelling, Induration) Measured by Investigator Rating After Aripiprazole 2M LAI 960 mg Injection Last injection: Mild Pain	5 Participants	—
Number of Participants With Injection Site Evaluations (Pain, Redness, Swelling, Induration) Measured by Investigator Rating After Aripiprazole 2M LAI 960 mg Injection First injection: Mild Redness	3 Participants	—
Number of Participants With Injection Site Evaluations (Pain, Redness, Swelling, Induration) Measured by Investigator Rating After Aripiprazole 2M LAI 960 mg Injection Third injection: Mild Redness	1 Participants	—
Number of Participants With Injection Site Evaluations (Pain, Redness, Swelling, Induration) Measured by Investigator Rating After Aripiprazole 2M LAI 960 mg Injection Last injection: Mild Redness	1 Participants	—

PRIMARY outcome

Timeframe: Day 1 (First injection) to Day 197 (Last injection)

Population: Safety sample included all randomized participants who received at least 1 dose of aripiprazole injection, regardless of any protocol violation. 'Number Analyzed' signifies number of participants with available data for this outcome measure at the specified timepoint. Participants whose injection-site reactions were assessed by the investigator, are reported in this outcome measure, and may differ from participants whose VAS scores were assessed for pain.

Outcome measures

Outcome measures
Measure	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder n=134 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Number of Participants With Injection Site Evaluations (Pain, Redness, Swelling, Induration) Measured by Investigator Rating After Aripiprazole IM Depot 400 mg Injection First Injection: Mild Pain	7 Participants	—
Number of Participants With Injection Site Evaluations (Pain, Redness, Swelling, Induration) Measured by Investigator Rating After Aripiprazole IM Depot 400 mg Injection Second Injection: Mild Pain	3 Participants	—
Number of Participants With Injection Site Evaluations (Pain, Redness, Swelling, Induration) Measured by Investigator Rating After Aripiprazole IM Depot 400 mg Injection Third Injection: Mild Pain	7 Participants	—
Number of Participants With Injection Site Evaluations (Pain, Redness, Swelling, Induration) Measured by Investigator Rating After Aripiprazole IM Depot 400 mg Injection Fourth Injection: Mild Pain	1 Participants	—
Number of Participants With Injection Site Evaluations (Pain, Redness, Swelling, Induration) Measured by Investigator Rating After Aripiprazole IM Depot 400 mg Injection Fifth Injection: Mild Pain	3 Participants	—
Number of Participants With Injection Site Evaluations (Pain, Redness, Swelling, Induration) Measured by Investigator Rating After Aripiprazole IM Depot 400 mg Injection Seventh Injection: Mild Pain	1 Participants	—
Number of Participants With Injection Site Evaluations (Pain, Redness, Swelling, Induration) Measured by Investigator Rating After Aripiprazole IM Depot 400 mg Injection Eighth Injection: Mild Pain	1 Participants	—
Number of Participants With Injection Site Evaluations (Pain, Redness, Swelling, Induration) Measured by Investigator Rating After Aripiprazole IM Depot 400 mg Injection Last injection: Mild Pain	3 Participants	—
Number of Participants With Injection Site Evaluations (Pain, Redness, Swelling, Induration) Measured by Investigator Rating After Aripiprazole IM Depot 400 mg Injection First injection: Mild Redness	1 Participants	—
Number of Participants With Injection Site Evaluations (Pain, Redness, Swelling, Induration) Measured by Investigator Rating After Aripiprazole IM Depot 400 mg Injection Second injection: Mild Redness	3 Participants	—

PRIMARY outcome

Timeframe: Baseline to Day 225

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. Suicidality was defined as reporting any suicidal ideation or behavior.

Outcome measures

Outcome measures
Measure	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder n=130 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder n=132 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Number of Participants With Suicidality as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)	4 Participants	4 Participants

PRIMARY outcome

Timeframe: Day 225

Population: Pharmacokinetics (PK) sample included all dosed participants who had 1 or more evaluable aripiprazole PK parameters. Overall number analyzed is the number of participants with data available for outcome measure (OM) analysis. As pre-specified in protocol and SAP, data for this OM was reported for participants with schizophrenia or bipolar I disorder who received aripiprazole 2M LAI 960 mg.

Outcome measures

Outcome measures
Measure	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder n=96 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Plasma Concentration of Aripiprazole 56 Days Postdose (C56) of Aripiprazole 2M LAI 960 mg After the Fourth Dose	250 ng/mL (nanogram per milliliter) Standard Deviation 128	—

PRIMARY outcome

Timeframe: Day 225

Population: PK sample included all dosed participants who had 1 or more evaluable aripiprazole PK parameters. Overall number analyzed is the number of participants with data available for outcome measure analysis. As pre-specified in protocol and SAP, data for this OM was reported for participants with schizophrenia or bipolar I disorder who received aripiprazole IM Depot 400 mg.

Outcome measures

Outcome measures
Measure	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder n=82 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Plasma Concentration of Aripiprazole 28 Days Postdose (C28) of Aripiprazole IM Depot 400 mg After the Eighth Dose	257 ng/mL Standard Deviation 162	—

PRIMARY outcome

Timeframe: Days 169 (predose and 4, 8, 12 hours post dose), 170, 171, 173, 176, 178, 181, 183, 186, 190, 197 (predose and 4, 8, 12 hours post dose), 198, 199, 201, 204, 206, 209, 211, 214, 218, 225

Population: PK sample included all dosed participants who had 1 or more evaluable aripiprazole PK parameters. Overall number analyzed is the number of participants with data available for outcome measure analysis. 'Number Analyzed' signifies number of participants with available data for this outcome measure at the specified timepoint. As pre-specified in protocol and SAP, data for this OM was reported for participants with schizophrenia or bipolar I disorder who received aripiprazole IM Depot 400 mg.

Outcome measures

Outcome measures
Measure	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder n=33 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Area Under the Plasma Concentration-Time Curve From Time 0 to 28 Days (AUC0-28) of Aripiprazole After the Seventh and Eighth Doses of Aripiprazole IM Depot 400 mg AUC0-28 After Seventh Dose (Day 169)	7760 day*ng/mL Standard Deviation 4300	—
Area Under the Plasma Concentration-Time Curve From Time 0 to 28 Days (AUC0-28) of Aripiprazole After the Seventh and Eighth Doses of Aripiprazole IM Depot 400 mg AUC0-28 After Eighth Dose (Day 197)	7840 day*ng/mL Standard Deviation 5170	—

PRIMARY outcome

Timeframe: Days 169 (predose and 4, 8, 12 hours post dose), 170, 171, 173, 176, 178, 181, 183, 186, 190, 197, 204, 211, 218, and 225

Outcome measures

Outcome measures
Measure	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder n=34 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Area Under the Plasma Concentration-Time Curve From Time 0 to 56 Days (AUC0-56) of Aripiprazole After the Fourth Dose of Aripiprazole 2M LAI 960 mg	14700 day*ng/mL Standard Deviation 7460	—

SECONDARY outcome

Timeframe: Days 1(predose [within 2 hours(h) prior to dosing]&4,8,12 h postdose),2,3,5,8,10,13,15,18,22,29,36,43,50,57(predose),85,113(predose),141,169(predose [within 2 h prior to dosing]& 4,8,12 h postdose),170,171,173,176,178,181,183,186,190,197,204,211,218 & 225

Population: PK sample included all dosed participants who have 1 or more evaluable aripiprazole PK parameters. Overall number analyzed is the number of participants with data available for outcome measure analysis. 'Number Analyzed' signifies number of participants with available data for this outcome measure at the specified timepoint. As pre-specified in protocol and SAP, data for this OM was reported for participants with schizophrenia or bipolar I disorder who received aripiprazole 2M LAI 960 mg.

Outcome measures

Outcome measures
Measure	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder n=37 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Maximum Observed Plasma Concentration (Cmax) of Aripiprazole After First and Fourth Doses of Aripiprazole 2M LAI 960 mg Cmax After Fourth Dose (Day 169)	342 ng/mL Standard Deviation 157	—
Maximum Observed Plasma Concentration (Cmax) of Aripiprazole After First and Fourth Doses of Aripiprazole 2M LAI 960 mg Cmax After First Dose (Day 1)	286 ng/mL Standard Deviation 203	—

SECONDARY outcome

Outcome measures

Outcome measures
Measure	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder n=37 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Time to Reach the Maximum Plasma Concentration (Tmax) of Aripiprazole After First and Fourth Doses of Aripiprazole 2M LAI 960 mg Tmax After First Dose (Day 1)	8.58 days Interval 3.92 to 55.9	—
Time to Reach the Maximum Plasma Concentration (Tmax) of Aripiprazole After First and Fourth Doses of Aripiprazole 2M LAI 960 mg Tmax After Fourth Dose (Day 169)	28.0 days Interval 0.93 to 49.0	—

SECONDARY outcome

Timeframe: Days 1 (predose and 4, 8, 12 hours post-dose), 2, 3, 5, 8, 10, 13, 15, 18, 22, 29, 36, 43, 50 and 57 (pre-dose)

Population: PK sample included all dosed participants who have 1 or more evaluable aripiprazole PK parameters. Overall number analyzed is the number of participants with data available for outcome measure analysis. As pre-specified in protocol and SAP, data for this OM was reported for participants with schizophrenia or bipolar I disorder who received aripiprazole 2M LAI 960 mg.

Outcome measures

Outcome measures
Measure	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder n=37 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
AUC0-56 After the First Dose of Aripiprazole 2M LAI 960 mg	9180 day*ng/mL Standard Deviation 4940	—

SECONDARY outcome

Timeframe: Predose on Day 57

Population: PK sample included all dosed participants who have 1 or more evaluable aripiprazole PK parameters. Overall number analyzed is the number of participants with data available for outcome measure analysis. As pre-specified in protocol and SAP, data for this OM was reported for participants with schizophrenia or bipolar I disorder who received aripiprazole 2M LAI 960 mg.

Outcome measures

Outcome measures
Measure	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder n=113 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Plasma Concentration of Aripiprazole 56 Days (C56) After the First Dose of Aripiprazole 2M LAI 960 mg	165 ng/mL Standard Deviation 91.7	—

SECONDARY outcome

Timeframe: Days 169 (predose and 4, 8, 12 hours postdose), 170, 171, 173, 176, 178, 181, 183, 186, 190, and 197

Population: PK sample included all dosed participants who have 1 or more evaluable aripiprazole PK parameters. Overall number analyzed is the number of participants with data available for outcome measure analysis. As pre-specified in protocol and SAP, data for this OM was reported for participants with schizophrenia or bipolar I disorder who received aripiprazole 2M LAI 960 mg.

Outcome measures

Outcome measures
Measure	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder n=34 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
AUC0-28 After the Fourth Dose of Aripiprazole 2M LAI 960 mg	7190 day*ng/mL Standard Deviation 3470	—

SECONDARY outcome

Timeframe: Days 204, 211, 218, and 225

Population: PK sample included all dosed participants who have 1 or more evaluable aripiprazole PK parameters. Overall number analyzed is the number of participants with data available for outcome measure analysis. As pre-specified in protocol and SAP, data for this OM was reported for participants with schizophrenia or bipolar I disorder who received aripiprazole 2M LAI 960 mg.

Outcome measures

Outcome measures
Measure	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder n=34 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Area Under the Plasma Concentration-Time Curve From Time 29 to 56 Days (AUC29-56) After the Fourth Dose of Aripiprazole 2M LAI 960 mg	7500 day*ng/mL Standard Deviation 4200	—

SECONDARY outcome

Timeframe: Days 169 (Predose [within 2 hours prior to dosing] and 4, 8, 12 hours post dose), 170, 171, 173, 176, 178, 181, 183, 186, 190, 197, 204, 211, 218, and 225

Population: PK sample included all dosed participants who have 1 or more evaluable aripiprazole PK parameters. Overall number analyzed is the number of participants with data available for outcome measure analysis. As pre-specified in protocol and SAP, data for this OM was reported for participants with schizophrenia or bipolar I disorder who received aripiprazole 2M LAI 960 mg.

PTF% was determined as 100\*(Cmax - Cmin \[minimum plasma concentration of the drug\])/Caverage (average steady-state plasma drug concentration during multiple-dose administration) following fourth dose.

Outcome measures

Outcome measures
Measure	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder n=34 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Peak-to-Trough Percent Fluctuation (PTF%) After the Fourth Dose of Aripiprazole 2M LAI 960 mg	63.4 percentage fluctuation Standard Deviation 25.1	—

SECONDARY outcome

Timeframe: Predose [within 2 hours prior to dosing; 4,8,12h postdose] on Days 1,169,197; Predose on Days 29,57,85,113,141; and on Days 2, 3, 5, 8, 10, 13, 15, 18, 22, 170, 171, 173, 176, 178, 181, 183, 186, 190,198, 199, 201, 204, 206, 209, 211, 214, 218, 225

Population: PK sample included all dosed participants who had 1 or more evaluable aripiprazole PK parameters. Overall number analyzed is the number of participants with data available for outcome measure analysis. 'Number Analyzed' signifies number of participants with available data for this outcome measure at the specified timepoint. As pre-specified in protocol and SAP, data for this OM was reported for participants with schizophrenia or bipolar I disorder who received aripiprazole IM Depot 400 mg.

Outcome measures

Outcome measures
Measure	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder n=35 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Cmax of Aripiprazole After the First, Seventh, and Eighth Doses of Aripiprazole IM Depot 400 mg Cmax After First Dose (Day 1)	280 ng/mL Standard Deviation 123	—
Cmax of Aripiprazole After the First, Seventh, and Eighth Doses of Aripiprazole IM Depot 400 mg Cmax After Seventh Dose (Day 169)	339 ng/mL Standard Deviation 168	—
Cmax of Aripiprazole After the First, Seventh, and Eighth Doses of Aripiprazole IM Depot 400 mg Cmax After Eighth Dose (Day 197)	344 ng/mL Standard Deviation 212	—

SECONDARY outcome

Population: PK sample included all dosed participants who had 1 or more evaluable aripiprazole PK parameters. Overall number analyzed is the number of participants with data available for outcome measure analysis. 'Number Analyzed' signifies number of participants with available data for this outcome measure at the specified timepoint. As pre-specified in protocol and SAP, data for this OM was reported for participants with schizophrenia or bipolar I disorder who received aripiprazole IM Depot 400 mg.

Outcome measures

Outcome measures
Measure	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder n=35 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Tmax of Aripiprazole After the First, Seventh, and Eighth Doses of Aripiprazole IM Depot 400 mg Tmax After Eighth Dose (Day 197)	4.07 days Interval 0.0 to 28.0	—
Tmax of Aripiprazole After the First, Seventh, and Eighth Doses of Aripiprazole IM Depot 400 mg Tmax After First Dose (Day 1)	9.04 days Interval 3.83 to 27.9	—
Tmax of Aripiprazole After the First, Seventh, and Eighth Doses of Aripiprazole IM Depot 400 mg Tmax After Seventh Dose (Day 169)	6.97 days Interval 1.05 to 28.0	—

SECONDARY outcome

Timeframe: Days 1 (predose and 4, 8, and 12 hours postdose), 2, 3, 5, 8, 10, 13, 15, 18, 22 and 29 (predose)

Outcome measures

Outcome measures
Measure	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder n=35 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
AUC0-28 After the First Dose of Aripiprazole IM Depot 400 mg	5030 day*ng/mL Standard Deviation 2580	—

SECONDARY outcome

Timeframe: Predose on Day 29

Outcome measures

Outcome measures
Measure	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder n=110 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Plasma Concentration of Aripiprazole 28 Days (C28) After the First Dose of Aripiprazole IM Depot 400 mg	112 ng/mL Standard Deviation 82.9	—

SECONDARY outcome

Timeframe: Days 197 (Predose [within 2 hours prior to dosing] and 4, 8, 12 hours post dose),198, 199, 201, 204, 206, 209, 211, 214, 218, 225

Outcome measures

Outcome measures
Measure	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder n=34 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
PTF% After the Eighth Dose of Aripiprazole IM Depot 400 mg	48.3 percentage fluctuation Standard Deviation 19.0	—

SECONDARY outcome

Timeframe: Day 8

Population: PK sample included all dosed participants who have 1 or more evaluable aripiprazole PK parameters. Overall number analyzed is the number of participants with data available for outcome measure analysis. As pre-specified in protocol and SAP, data for this OM was reported for participants with schizophrenia or bipolar I disorder who received aripiprazole 2M LAI 960 mg.

Outcome measures

Outcome measures
Measure	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder n=41 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Plasma Concentration of Aripiprazole 7 Days Post First Dose (C7) of Aripiprazole 2M LAI 960 mg	221 ng/mL Standard Deviation 178	—

SECONDARY outcome

Timeframe: Day 15

Population: PK sample included all dosed participants who have 1 or more evaluable aripiprazole PK parameters. Overall number analyzed is the number of participants with data available for outcome measure analysis. As pre-specified in protocol and SAP, data for this OM was reported for participants with schizophrenia or bipolar I disorder who received aripiprazole IM Depot 400 mg.

Outcome measures

Outcome measures
Measure	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder n=39 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Plasma Concentration of Aripiprazole Post First Dose (C14) of Aripiprazole IM Depot 400 mg	229 ng/mL Standard Deviation 121	—

SECONDARY outcome

Timeframe: Baseline, Week 32

Population: Efficacy sample set included all randomized participants who received at least 1 dose of aripiprazole injection and have had at least 1 efficacy assessment. Overall number analyzed is the number of participants with data available for outcome measure analysis.

The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome). Higher scores indicate worse condition. The PANSS was assessed for schizophrenia participants only.

Outcome measures

Outcome measures
Measure	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder n=89 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder n=85 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Mean Change From Baseline in Positive and Negative Syndrome Scale Rating Criteria (PANSS) Total Score	-2.6 score on a scale Standard Deviation 11.7	-1.7 score on a scale Standard Deviation 8.5

SECONDARY outcome

Timeframe: Baseline, Week 32

The CGI-S is a standardized, clinician-administered global rating scale that measures disease severity. To assess CGI-S, the rater or investigator answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?" Response choices include: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants. The cumulative score range is 0-7. A higher score on the CGI-S represents a higher severity of disease. The CGI-S scale was assessed for schizophrenia participants only.

Outcome measures

Outcome measures
Measure	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder n=89 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder n=85 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Mean Change From Baseline in Clinical Global Impression - Severity Scale (CGI-S) Score	-0.3 score on a scale Standard Deviation 0.6	-0.1 score on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: Baseline, Week 32

The CGI-I scale is a clinician rated scale which assesses the improvement of illness for each participant. To assess CGI-I, the rater or investigator rated the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared with the participant's condition at baseline. Response choices include: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. Scores range from 0 to 7. Higher scores indicate worse condition.

Outcome measures

Outcome measures
Measure	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder n=123 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder n=117 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Mean Change From Baseline in Clinical Global Impression - Improvement Scale (CGI-I) Score	3.4 score on a scale Standard Deviation 1.1	3.5 score on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: Baseline, Week 32

The participant's feeling of their own well-being was assessed using the 20-question SWN-S. The SWN-S was a validated self-report instrument that evaluated the participant's perception of well-being while receiving antipsychotic medication. The questionnaire consisted of 20 items (10 positive and 10 negative statements) and 5 subscales (mental functioning, social integration, emotional regulation, physical functioning, self-control) whose items followed in random order. For items marked with a '+', the response choices and scoring is not at all = 1, hardly at all = 2, a little = 3, somewhat = 4, much = 5, and very much = 6. For items marked with a '- ', the scoring is reversed; response choices and scoring are as follows: not at all = 6, hardly at all = 5, a little = 4, somewhat = 3, much = 2, very much = 1. SWN-S subscale score's each item was rated on a score of 1 (none) to 6 (severe), and total score ranged from 20 to 120, with higher scores indicating stronger subjective feeling

Outcome measures

Outcome measures
Measure	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder n=125 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder n=121 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Mean Change From Baseline in Subjective Well-Being Under Neuroleptic Treatment-Short Form (SWN-S) Total Score	3.2 score on a scale Standard Deviation 15.8	0.5 score on a scale Standard Deviation 18.2

SECONDARY outcome

Timeframe: Baseline, Week 32

The MADRS is a diagnostic questionnaire used by clinician to assess the participant's severity of depression. This scale consists of 10 items each with 7 defined grades of severity on 0 to 6 scale (reported sadness, apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts). MADRS total score is sum of 10 individual item scores ranging from 0-60 categorized as: 0 to 6: normal/symptoms absent, 7 to 19: mild depression, 20 to 34: moderate depression, and 35 to 60: severe depression. Higher score indicates more depressive symptoms. The MADRS was assessed for bipolar I disorder participants only.

Outcome measures

Outcome measures
Measure	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder n=39 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder n=40 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score	-3.5 score on a scale Standard Deviation 9.1	-3.3 score on a scale Standard Deviation 12.5

SECONDARY outcome

Timeframe: Baseline, Week 32

The YMRS is an 11-item, multiple-choice diagnostic questionnaire which psychiatrists use to assess the core symptoms of mania and is based on the participants subjective report of their condition. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. Total score is summed of 11 items. Total score range is from 0 to 60 and the higher score represent a worse outcome. The YMRS was assessed for bipolar I disorder participants only.

Outcome measures

Outcome measures
Measure	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder n=39 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder n=40 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Mean Change From Baseline in Young Mania Rating Scale (YMRS) Total Score	-1.9 score on a scale Standard Deviation 7.1	-4.7 score on a scale Standard Deviation 7.7

SECONDARY outcome

Timeframe: Baseline, Week 32

The CGI-BP scale refers to the global impression of the participants with respect to bipolar disorder. The scale rates the participant's severity of illness (CGI-BP-Severity: mania, depression, and overall bipolar illness) and change from preceding phase (CGI-BP change from preceding phase: mania, depression, and overall bipolar illness) based on a 7-point scale ranging from 1 (normal, not ill) to 7 (very severely ill). A negative change score signifies improvement. The CGI-BP was assessed for bipolar I disorder participants only.

Outcome measures

Outcome measures
Measure	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder n=39 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder n=40 Participants Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Mean Change From Baseline in Clinical Global Impression - Bipolar Version (CGI-BP) Severity of Illness Score	-0.2 score on a scale Standard Deviation 1.0	-0.6 score on a scale Standard Deviation 1.2

Adverse Events

Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder

Serious events: 6 serious events

Other events: 92 other events

Deaths: 1 deaths

Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder

Serious events: 8 serious events

Other events: 92 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder n=132 participants at risk Participants with schizophrenia or bipolar I disorder received aripiprazole 2M LAI 960 mg, for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder n=134 participants at risk Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.
Cardiac disorders Cardiac Arrest	0.76% 1/132 • From first dose of study drug up to 56 days (2M LAI 960 mg) or 28 days (IM depot 400 mg) post last dose of study drug (up to approximately 11 months) Safety sample included all randomized participants who received at least 1 dose of aripiprazole injection, regardless of any protocol violation.	0.00% 0/134 • From first dose of study drug up to 56 days (2M LAI 960 mg) or 28 days (IM depot 400 mg) post last dose of study drug (up to approximately 11 months) Safety sample included all randomized participants who received at least 1 dose of aripiprazole injection, regardless of any protocol violation.
Hepatobiliary disorders Cholecystitis Acute	0.00% 0/132 • From first dose of study drug up to 56 days (2M LAI 960 mg) or 28 days (IM depot 400 mg) post last dose of study drug (up to approximately 11 months) Safety sample included all randomized participants who received at least 1 dose of aripiprazole injection, regardless of any protocol violation.	0.75% 1/134 • From first dose of study drug up to 56 days (2M LAI 960 mg) or 28 days (IM depot 400 mg) post last dose of study drug (up to approximately 11 months) Safety sample included all randomized participants who received at least 1 dose of aripiprazole injection, regardless of any protocol violation.
Infections and infestations Cellulitis	0.76% 1/132 • From first dose of study drug up to 56 days (2M LAI 960 mg) or 28 days (IM depot 400 mg) post last dose of study drug (up to approximately 11 months) Safety sample included all randomized participants who received at least 1 dose of aripiprazole injection, regardless of any protocol violation.	0.00% 0/134 • From first dose of study drug up to 56 days (2M LAI 960 mg) or 28 days (IM depot 400 mg) post last dose of study drug (up to approximately 11 months) Safety sample included all randomized participants who received at least 1 dose of aripiprazole injection, regardless of any protocol violation.
Infections and infestations Septic Shock	0.00% 0/132 • From first dose of study drug up to 56 days (2M LAI 960 mg) or 28 days (IM depot 400 mg) post last dose of study drug (up to approximately 11 months) Safety sample included all randomized participants who received at least 1 dose of aripiprazole injection, regardless of any protocol violation.	0.75% 1/134 • From first dose of study drug up to 56 days (2M LAI 960 mg) or 28 days (IM depot 400 mg) post last dose of study drug (up to approximately 11 months) Safety sample included all randomized participants who received at least 1 dose of aripiprazole injection, regardless of any protocol violation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of Colon	0.00% 0/132 • From first dose of study drug up to 56 days (2M LAI 960 mg) or 28 days (IM depot 400 mg) post last dose of study drug (up to approximately 11 months) Safety sample included all randomized participants who received at least 1 dose of aripiprazole injection, regardless of any protocol violation.	0.75% 1/134 • From first dose of study drug up to 56 days (2M LAI 960 mg) or 28 days (IM depot 400 mg) post last dose of study drug (up to approximately 11 months) Safety sample included all randomized participants who received at least 1 dose of aripiprazole injection, regardless of any protocol violation.
Nervous system disorders Akathisia	0.76% 1/132 • From first dose of study drug up to 56 days (2M LAI 960 mg) or 28 days (IM depot 400 mg) post last dose of study drug (up to approximately 11 months) Safety sample included all randomized participants who received at least 1 dose of aripiprazole injection, regardless of any protocol violation.	0.75% 1/134 • From first dose of study drug up to 56 days (2M LAI 960 mg) or 28 days (IM depot 400 mg) post last dose of study drug (up to approximately 11 months) Safety sample included all randomized participants who received at least 1 dose of aripiprazole injection, regardless of any protocol violation.
Psychiatric disorders Depression	0.00% 0/132 • From first dose of study drug up to 56 days (2M LAI 960 mg) or 28 days (IM depot 400 mg) post last dose of study drug (up to approximately 11 months) Safety sample included all randomized participants who received at least 1 dose of aripiprazole injection, regardless of any protocol violation.	0.75% 1/134 • From first dose of study drug up to 56 days (2M LAI 960 mg) or 28 days (IM depot 400 mg) post last dose of study drug (up to approximately 11 months) Safety sample included all randomized participants who received at least 1 dose of aripiprazole injection, regardless of any protocol violation.
Psychiatric disorders Depressive Symptom	0.00% 0/132 • From first dose of study drug up to 56 days (2M LAI 960 mg) or 28 days (IM depot 400 mg) post last dose of study drug (up to approximately 11 months) Safety sample included all randomized participants who received at least 1 dose of aripiprazole injection, regardless of any protocol violation.	0.75% 1/134 • From first dose of study drug up to 56 days (2M LAI 960 mg) or 28 days (IM depot 400 mg) post last dose of study drug (up to approximately 11 months) Safety sample included all randomized participants who received at least 1 dose of aripiprazole injection, regardless of any protocol violation.
Psychiatric disorders Hallucination, auditory	1.5% 2/132 • From first dose of study drug up to 56 days (2M LAI 960 mg) or 28 days (IM depot 400 mg) post last dose of study drug (up to approximately 11 months) Safety sample included all randomized participants who received at least 1 dose of aripiprazole injection, regardless of any protocol violation.	0.00% 0/134 • From first dose of study drug up to 56 days (2M LAI 960 mg) or 28 days (IM depot 400 mg) post last dose of study drug (up to approximately 11 months) Safety sample included all randomized participants who received at least 1 dose of aripiprazole injection, regardless of any protocol violation.
Psychiatric disorders Psychotic Disorder	0.76% 1/132 • From first dose of study drug up to 56 days (2M LAI 960 mg) or 28 days (IM depot 400 mg) post last dose of study drug (up to approximately 11 months) Safety sample included all randomized participants who received at least 1 dose of aripiprazole injection, regardless of any protocol violation.	0.75% 1/134 • From first dose of study drug up to 56 days (2M LAI 960 mg) or 28 days (IM depot 400 mg) post last dose of study drug (up to approximately 11 months) Safety sample included all randomized participants who received at least 1 dose of aripiprazole injection, regardless of any protocol violation.
Psychiatric disorders Schizophrenia	0.00% 0/132 • From first dose of study drug up to 56 days (2M LAI 960 mg) or 28 days (IM depot 400 mg) post last dose of study drug (up to approximately 11 months) Safety sample included all randomized participants who received at least 1 dose of aripiprazole injection, regardless of any protocol violation.	0.75% 1/134 • From first dose of study drug up to 56 days (2M LAI 960 mg) or 28 days (IM depot 400 mg) post last dose of study drug (up to approximately 11 months) Safety sample included all randomized participants who received at least 1 dose of aripiprazole injection, regardless of any protocol violation.
Psychiatric disorders Suicide Attempt	0.00% 0/132 • From first dose of study drug up to 56 days (2M LAI 960 mg) or 28 days (IM depot 400 mg) post last dose of study drug (up to approximately 11 months) Safety sample included all randomized participants who received at least 1 dose of aripiprazole injection, regardless of any protocol violation.	0.75% 1/134 • From first dose of study drug up to 56 days (2M LAI 960 mg) or 28 days (IM depot 400 mg) post last dose of study drug (up to approximately 11 months) Safety sample included all randomized participants who received at least 1 dose of aripiprazole injection, regardless of any protocol violation.

Other adverse events

Additional Information

Global Clinical Development

Otsuka Pharmaceutical Development & Commercialization, Inc.

Phone: 1-609-524-6788

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place