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

A Phase 1b, Open-label, Multiple-dose, Randomized, Parallel-arm, Safety, Tolerability, and Pharmacokinetic Trial of Aripiprazole Intramuscular Depot Administered in the Gluteal Muscle in Adult Subjects With Schizophrenia or Bipolar I Disorder

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04030143

Enrollment

266

Registered

2019-07-23

Start date

2019-08-01

Completion date

2020-07-08

Last updated

2023-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar I Disorder, Schizophrenia

Keywords

Aripiprazole, Aripiprazole Intramuscular Depot, Gluteal Muscle, Long Acting Injection

Brief summary

The purpose of this trial is to determine the safety and tolerability of multiple-dose administrations of aripiprazole, to establish the similarity of aripiprazole concentrations on the last day of the dosing interval following the final administration of aripiprazole into the gluteal muscle site, and to establish the similarity of aripiprazole exposure over the dosing interval following the administration of aripiprazole into the gluteal muscle site in adult participants with schizophrenia or bipolar I disorder.

Interventions

DRUGAripiprazole

Administered as an intramuscular (IM) depot injection.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

Inclusion criteria

* A current diagnosis of schizophrenia or bipolar I disorder, as defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria. * Body mass index of 18 to 35 kilograms per meter square (kg/m\^2). * On a stable dose of an atypical oral antipsychotic medication for at least 2 months prior to screening.

Exclusion criteria

* Participants who have: * Met DSM-5 criteria for substance use disorder within the past 180 days. * A positive drug screen for drugs of abuse * Use of any psychotropic medications other than their current non-aripiprazole antipsychotic or mood stabilizer(s) medication; or participants who use more than one antipsychotic or mood stabilizer(s) medication at screening. * Females who are pregnant, breast-feeding, lactating, and/or have a positive pregnancy test result prior to receiving investigational medicinal product (IMP). A negative serum pregnancy test must be confirmed prior to the first dose of IMP for all female participants. * Any major surgery within 30 days prior to enrollment or scheduled/elective surgery during the trial. * Evidence of organ dysfunction or any clinically significant deviation from normal in the physical, electrocardiographic, or clinical laboratory examinations. * Participants currently in an acute relapse of schizophrenia. * Participants with a current DSM-5 diagnosis other than schizophrenia or bipolar I disorder, including schizoaffective disorder, major depressive disorder, delirium, dementia, amnestic, or other cognitive disorders. Also, participants with borderline, paranoid, histrionic, or antisocial personality disorder. * Participants with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia. * History of any significant drug allergy or known or suspected hypersensitivity, in particular to aripiprazole or other quinolinones. * History of or current hepatitis or acquired immunodeficiency syndrome or carriers of Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies (anti-HCV), and/or Human immunodeficiency virus (HIV) antibodies. * Participants deemed intolerant of receiving injections. * Participants who have had electroconvulsive therapy within 2 months of administration of IMP.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With One or More Treatment-Emergent Adverse Events (TEAEs)	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)	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.
Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities	From first dose of study drug up to Day 225	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.
Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities	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).
Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities	From first dose of study drug up to Day 225	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.
Mean Change From Baseline in Simpson-Angus Neurologic Rating Scale (SAS) Total Score	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.
Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Score	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.
Mean Change From Baseline in Barnes Akathisia Rating Score (BARS) Global Score	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.
Visual Analog Scale (VAS) Scores for Pain Perception of Aripiprazole 2M LAI 960 mg	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).
VAS Scores for Pain Perception of Aripiprazole IM Depot 400 mg	Day 1 (First injection) to Day 197 (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).
Number of Participants With Injection Site Evaluations (Pain, Redness, Swelling, Induration) Measured by Investigator Rating After Aripiprazole 2M LAI 960 mg Injection	Day 1 (First injection) to Day 169 (Last injection)	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.
Number of Participants With Injection Site Evaluations (Pain, Redness, Swelling, Induration) Measured by Investigator Rating After Aripiprazole IM Depot 400 mg Injection	Day 1 (First injection) to Day 197 (Last injection)	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.
Number of Participants With Suicidality as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)	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.
Plasma Concentration of Aripiprazole 56 Days Postdose (C56) of Aripiprazole 2M LAI 960 mg After the Fourth Dose	Day 225	—
Plasma Concentration of Aripiprazole 28 Days Postdose (C28) of Aripiprazole IM Depot 400 mg After the Eighth Dose	Day 225	—
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	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	—
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	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	—

Secondary

Measure	Time frame	Description
Maximum Observed Plasma Concentration (Cmax) of Aripiprazole After First and Fourth Doses of Aripiprazole 2M LAI 960 mg	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	—
Time to Reach the Maximum Plasma Concentration (Tmax) of Aripiprazole After First and Fourth Doses of Aripiprazole 2M LAI 960 mg	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	—
AUC0-56 After the First Dose of Aripiprazole 2M LAI 960 mg	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)	—
Plasma Concentration of Aripiprazole 56 Days (C56) After the First Dose of Aripiprazole 2M LAI 960 mg	Predose on Day 57	—
AUC0-28 After the Fourth Dose of Aripiprazole 2M LAI 960 mg	Days 169 (predose and 4, 8, 12 hours postdose), 170, 171, 173, 176, 178, 181, 183, 186, 190, and 197	—
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	Days 204, 211, 218, and 225	—
Peak-to-Trough Percent Fluctuation (PTF%) After the Fourth Dose of Aripiprazole 2M LAI 960 mg	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	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.
Cmax of Aripiprazole After the First, Seventh, and Eighth Doses of Aripiprazole IM Depot 400 mg	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	—
Tmax of Aripiprazole After the First, Seventh, and Eighth Doses of Aripiprazole IM Depot 400 mg	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	—
AUC0-28 After the First Dose of Aripiprazole IM Depot 400 mg	Days 1 (predose and 4, 8, and 12 hours postdose), 2, 3, 5, 8, 10, 13, 15, 18, 22 and 29 (predose)	—
Plasma Concentration of Aripiprazole 28 Days (C28) After the First Dose of Aripiprazole IM Depot 400 mg	Predose on Day 29	—
PTF% After the Eighth Dose of Aripiprazole IM Depot 400 mg	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	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 eighth dose.
Plasma Concentration of Aripiprazole 7 Days Post First Dose (C7) of Aripiprazole 2M LAI 960 mg	Day 8	—
Plasma Concentration of Aripiprazole Post First Dose (C14) of Aripiprazole IM Depot 400 mg	Day 15	—
Mean Change From Baseline in Positive and Negative Syndrome Scale Rating Criteria (PANSS) Total Score	Baseline, Week 32	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.
Mean Change From Baseline in Clinical Global Impression - Severity Scale (CGI-S) Score	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.
Mean Change From Baseline in Clinical Global Impression - Improvement Scale (CGI-I) Score	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.
Mean Change From Baseline in Subjective Well-Being Under Neuroleptic Treatment-Short Form (SWN-S) Total Score	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
Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score	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.
Mean Change From Baseline in Young Mania Rating Scale (YMRS) Total Score	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.
Mean Change From Baseline in Clinical Global Impression - Bipolar Version (CGI-BP) Severity of Illness Score	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.

Countries

United States

Participant flow

Recruitment details

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

Participants by arm

Arm	Count
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder 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.	132
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.	134
Total	266

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	5	10
Overall Study	Due to Covid-19	2	3
Overall Study	Lost to Follow-up	3	7
Overall Study	Not Due to Covid-19	1	1
Overall Study	Physician Decision	1	1
Overall Study	Protocol Deviation	2	2
Overall Study	Withdrawal by Subject	16	18

Baseline characteristics

Characteristic	Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Total
Age, Continuous	47.8 years STANDARD_DEVIATION 10.8	46.8 years STANDARD_DEVIATION 11.7	47.3 years STANDARD_DEVIATION 11.3
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants	11 Participants	23 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	119 Participants	122 Participants	241 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants	1 Participants	2 Participants
Race/Ethnicity, Customized Race Asian	3 Participants	4 Participants	7 Participants
Race/Ethnicity, Customized Race Black or African American	99 Participants	95 Participants	194 Participants
Race/Ethnicity, Customized Race Other	1 Participants	2 Participants	3 Participants
Race/Ethnicity, Customized Race White	29 Participants	33 Participants	62 Participants
Sex: Female, Male Female	42 Participants	48 Participants	90 Participants
Sex: Female, Male Male	90 Participants	86 Participants	176 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	1 / 132	0 / 134
other Total, other adverse events	92 / 132	92 / 134
serious Total, serious adverse events	6 / 132	8 / 134

Outcome results

Primary

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

Time frame: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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

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

Time frame: 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

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 2M LAI 960 mg.

Arm	Measure	Value (MEAN)	Dispersion
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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

Primary

Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Score

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.

Time frame: Baseline, Week 32

Arm	Measure	Group	Value (MEAN)	Dispersion
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Score	Baseline	0.1 score on a scale	Standard Deviation 1
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Score	Baseline	0.1 score on a scale	Standard Deviation 0.7
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Score	Change from Baseline at Week 32	-0.1 score on a scale	Standard Deviation 0.6

Primary

Mean Change From Baseline in Barnes Akathisia Rating Score (BARS) Global Score

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.

Time frame: Baseline, Week 32

Arm	Measure	Group	Value (MEAN)	Dispersion
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Mean Change From Baseline in Barnes Akathisia Rating Score (BARS) Global Score	Baseline	0.1 score on a scale	Standard Deviation 0.3
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Mean Change From Baseline in Barnes Akathisia Rating Score (BARS) Global Score	Baseline	0.1 score on a scale	Standard Deviation 0.3
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	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 0.4

Primary

Mean Change From Baseline in Simpson-Angus Neurologic Rating 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 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.

Time frame: Baseline, Week 32

Arm	Measure	Group	Value (MEAN)	Dispersion
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Mean Change From Baseline in Simpson-Angus Neurologic Rating Scale (SAS) Total Score	Baseline	0.2 score on a scale	Standard Deviation 0.6
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Mean Change From Baseline in Simpson-Angus Neurologic Rating Scale (SAS) Total Score	Baseline	0.2 score on a scale	Standard Deviation 0.4
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Mean Change From Baseline in Simpson-Angus Neurologic Rating Scale (SAS) Total Score	Change From Baseline at Week 32	0.1 score on a scale	Standard Deviation 0.6

Primary

Number of Participants With Injection Site Evaluations (Pain, Redness, Swelling, Induration) Measured by Investigator Rating After Aripiprazole 2M LAI 960 mg Injection

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.

Time frame: 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.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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

Number of Participants With Injection Site Evaluations (Pain, Redness, Swelling, Induration) Measured by Investigator Rating After Aripiprazole IM Depot 400 mg Injection

Time frame: 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.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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

Number of Participants With One or More Treatment-Emergent Adverse Events (TEAEs)

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.

Time frame: 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.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With One or More Treatment-Emergent Adverse Events (TEAEs)	94 Participants
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With One or More Treatment-Emergent Adverse Events (TEAEs)	95 Participants

Primary

Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities

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.

Time frame: 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.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities	High Glucose (mg/dL)	7 Participants
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities	Low Hematocrit (%)	7 Participants
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities	High Aspartate Aminotransferase (U/L)	0 Participants
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities	Low Hemoglobin (g/dL)	4 Participants
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities	High Potassium (mEq/L)	5 Participants
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities	Low Leukocytes (10^9/L)	0 Participants
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities	High Creatinine (mg/dL)	2 Participants
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities	High Platelets (10^9/L)	0 Participants
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities	High Urate (mg/dL)	2 Participants
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities	High Glucose, Urine	5 Participants
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities	High Creatine Kinase (U/L)	12 Participants
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities	High Protein, Urine	1 Participants
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities	High Eosinophils/Leukocytes (%)	2 Participants
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities	High Prolactin (ng/mL)	2 Participants
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities	High Alanine Aminotransferase (U/L)	1 Participants
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities	High Prolactin (ng/mL)	4 Participants
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities	High Alanine Aminotransferase (U/L)	2 Participants
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities	High Aspartate Aminotransferase (U/L)	2 Participants
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities	High Creatine Kinase (U/L)	1 Participants
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities	High Creatinine (mg/dL)	1 Participants
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities	High Glucose (mg/dL)	3 Participants
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities	High Potassium (mEq/L)	4 Participants
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities	High Urate (mg/dL)	0 Participants
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities	High Eosinophils/Leukocytes (%)	0 Participants
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities	Low Hematocrit (%)	8 Participants
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities	Low Hemoglobin (g/dL)	9 Participants
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities	Low Leukocytes (10^9/L)	3 Participants
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities	High Platelets (10^9/L)	1 Participants
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities	High Glucose, Urine	6 Participants
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities	High Protein, Urine	2 Participants

Primary

Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities

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).

Time frame: 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.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities	Bradycardia	0 Participants
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities	Sinus Bradycardia	0 Participants
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities	Supraventricular Premature Beat	13 Participants
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities	Ventricular Premature Beat	17 Participants
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities	Right Bundle Branch Block	1 Participants
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities	Myocardial Ischemia	3 Participants
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities	Symmetrical T-Wave Inversion	12 Participants
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities	QTcB	1 Participants
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities	QTcF	0 Participants
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities	QTcN	0 Participants
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities	QTcB	1 Participants
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities	Bradycardia	2 Participants
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities	Myocardial Ischemia	7 Participants
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities	Sinus Bradycardia	2 Participants
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities	QTcN	1 Participants
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities	Supraventricular Premature Beat	10 Participants
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities	Symmetrical T-Wave Inversion	12 Participants
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities	Ventricular Premature Beat	12 Participants
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities	QTcF	1 Participants
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities	Right Bundle Branch Block	0 Participants

Primary

Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities

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.

Time frame: From first dose of study drug up to Day 225

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities	Heart Rate Supine: Low	0 Participants
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities	Heart Rate Supine: High	2 Participants
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities	Systolic Blood Pressure Supine: Low	1 Participants
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities	Systolic Blood Pressure Supine: High	0 Participants
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities	Diastolic Blood Pressure Supine: Low	1 Participants
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities	Diastolic Blood Pressure Supine: High	1 Participants
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities	Heart Rate Standing: High	4 Participants
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities	Systolic Blood Pressure Standing: Low	1 Participants
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities	Systolic Blood Pressure Standing: High	0 Participants
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities	Diastolic Blood Pressure Standing: High	2 Participants
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities	Weight: Low	12 Participants
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities	Weight: High	52 Participants
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities	Temperature: High	4 Participants
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities	Orthostatic Hypotension: Low	2 Participants
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities	Weight: Low	11 Participants
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities	Heart Rate Supine: Low	1 Participants
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities	Systolic Blood Pressure Standing: Low	4 Participants
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities	Heart Rate Supine: High	1 Participants
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities	Temperature: High	4 Participants
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities	Systolic Blood Pressure Supine: Low	2 Participants
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities	Systolic Blood Pressure Standing: High	2 Participants
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities	Systolic Blood Pressure Supine: High	1 Participants
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities	Weight: High	54 Participants
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities	Diastolic Blood Pressure Supine: Low	1 Participants
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities	Diastolic Blood Pressure Standing: High	3 Participants
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities	Diastolic Blood Pressure Supine: High	1 Participants
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities	Orthostatic Hypotension: Low	2 Participants
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities	Heart Rate Standing: High	6 Participants

Primary

Number of Participants With Suicidality as Assessed by 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. Suicidality was defined as reporting any suicidal ideation or behavior.

Time frame: Baseline to Day 225

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Suicidality as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)	4 Participants
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Number of Participants With Suicidality as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)	4 Participants

Primary

Plasma Concentration of Aripiprazole 28 Days Postdose (C28) of Aripiprazole IM Depot 400 mg After the Eighth Dose

Time frame: 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.

Arm	Measure	Value (MEAN)	Dispersion
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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

Plasma Concentration of Aripiprazole 56 Days Postdose (C56) of Aripiprazole 2M LAI 960 mg After the Fourth Dose

Time frame: 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.

Arm	Measure	Value (MEAN)	Dispersion
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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

VAS Scores for Pain Perception of Aripiprazole IM Depot 400 mg

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).

Time frame: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	VAS Scores for Pain Perception of Aripiprazole IM Depot 400 mg	First Injection: Predose	1.6 score on a scale	Standard Deviation 2.37
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	VAS Scores for Pain Perception of Aripiprazole IM Depot 400 mg	Second Injection: Predose	1.5 score on a scale	Standard Deviation 2.66
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	VAS Scores for Pain Perception of Aripiprazole IM Depot 400 mg	Third Injection: Predose	0.8 score on a scale	Standard Deviation 1.1
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	VAS Scores for Pain Perception of Aripiprazole IM Depot 400 mg	Fourth Injection: Predose	0.7 score on a scale	Standard Deviation 0.79
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	VAS Scores for Pain Perception of Aripiprazole IM Depot 400 mg	Fifth Injection: Predose	0.7 score on a scale	Standard Deviation 0.82
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	VAS Scores for Pain Perception of Aripiprazole IM Depot 400 mg	Sixth Injection: Predose	0.8 score on a scale	Standard Deviation 1.11
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	VAS Scores for Pain Perception of Aripiprazole IM Depot 400 mg	Sixth Injection: Post dose	0.8 score on a scale	Standard Deviation 1.2
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	VAS Scores for Pain Perception of Aripiprazole IM Depot 400 mg	Seventh Injection: Predose	0.6 score on a scale	Standard Deviation 0.77
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	VAS Scores for Pain Perception of Aripiprazole IM Depot 400 mg	Seventh Injection: Post dose	1.0 score on a scale	Standard Deviation 2.3
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	VAS Scores for Pain Perception of Aripiprazole IM Depot 400 mg	Eighth Injection: Predose	0.6 score on a scale	Standard Deviation 0.69
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	VAS Scores for Pain Perception of Aripiprazole IM Depot 400 mg	Last Injection: Predose	0.9 score on a scale	Standard Deviation 1
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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

Primary

Visual Analog Scale (VAS) Scores for Pain Perception of Aripiprazole 2M LAI 960 mg

Time frame: Day 1 (First injection) to Day 169 (Last injection)

Arm	Measure	Group	Value (MEAN)	Dispersion
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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

Secondary

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

Time frame: 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.

Arm	Measure	Value (MEAN)	Dispersion
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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

AUC0-28 After the First Dose of Aripiprazole IM Depot 400 mg

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

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.

Arm	Measure	Value (MEAN)	Dispersion
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	AUC0-28 After the First Dose of Aripiprazole IM Depot 400 mg	5030 day*ng/mL	Standard Deviation 2580

Secondary

AUC0-28 After the Fourth Dose of Aripiprazole 2M LAI 960 mg

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

Arm	Measure	Value (MEAN)	Dispersion
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	AUC0-28 After the Fourth Dose of Aripiprazole 2M LAI 960 mg	7190 day*ng/mL	Standard Deviation 3470

Secondary

AUC0-56 After the First Dose of Aripiprazole 2M LAI 960 mg

Time frame: 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)

Arm	Measure	Value (MEAN)	Dispersion
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	AUC0-56 After the First Dose of Aripiprazole 2M LAI 960 mg	9180 day*ng/mL	Standard Deviation 4940

Secondary

Cmax of Aripiprazole After the First, Seventh, and Eighth Doses of Aripiprazole IM Depot 400 mg

Time frame: 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

Arm	Measure	Group	Value (MEAN)	Dispersion
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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

Maximum Observed Plasma Concentration (Cmax) of Aripiprazole After First and Fourth Doses of Aripiprazole 2M LAI 960 mg

Time frame: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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

Secondary

Mean Change From Baseline in Clinical Global Impression - Bipolar Version (CGI-BP) Severity of Illness Score

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.

Time frame: 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.

Arm	Measure	Value (MEAN)	Dispersion
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Mean Change From Baseline in Clinical Global Impression - Bipolar Version (CGI-BP) Severity of Illness Score	-0.6 score on a scale	Standard Deviation 1.2

Secondary

Mean Change From Baseline in Clinical Global Impression - Improvement Scale (CGI-I) Score

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.

Time frame: Baseline, Week 32

Arm	Measure	Value (MEAN)	Dispersion
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Mean Change From Baseline in Clinical Global Impression - Improvement Scale (CGI-I) Score	3.4 score on a scale	Standard Deviation 1.1
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Mean Change From Baseline in Clinical Global Impression - Improvement Scale (CGI-I) Score	3.5 score on a scale	Standard Deviation 1.1

Secondary

Mean Change From Baseline in Clinical Global Impression - Severity Scale (CGI-S) Score

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.

Time frame: Baseline, Week 32

Arm	Measure	Value (MEAN)	Dispersion
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Mean Change From Baseline in Clinical Global Impression - Severity Scale (CGI-S) Score	-0.3 score on a scale	Standard Deviation 0.6
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Mean Change From Baseline in Clinical Global Impression - Severity Scale (CGI-S) Score	-0.1 score on a scale	Standard Deviation 0.7

Secondary

Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

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.

Time frame: Baseline, Week 32

Arm	Measure	Value (MEAN)	Dispersion
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score	-3.5 score on a scale	Standard Deviation 9.1
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score	-3.3 score on a scale	Standard Deviation 12.5

Secondary

Mean Change From Baseline in Positive and Negative Syndrome Scale Rating Criteria (PANSS) Total Score

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.

Time frame: Baseline, Week 32

Arm	Measure	Value (MEAN)	Dispersion
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Mean Change From Baseline in Positive and Negative Syndrome Scale Rating Criteria (PANSS) Total Score	-1.7 score on a scale	Standard Deviation 8.5

Secondary

Mean Change From Baseline in Subjective Well-Being Under Neuroleptic Treatment-Short Form (SWN-S) Total Score

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

Time frame: Baseline, Week 32

Arm	Measure	Value (MEAN)	Dispersion
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Mean Change From Baseline in Subjective Well-Being Under Neuroleptic Treatment-Short Form (SWN-S) Total Score	0.5 score on a scale	Standard Deviation 18.2

Secondary

Mean Change From Baseline in Young Mania Rating Scale (YMRS) Total Score

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.

Time frame: Baseline, Week 32

Arm	Measure	Value (MEAN)	Dispersion
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Mean Change From Baseline in Young Mania Rating Scale (YMRS) Total Score	-1.9 score on a scale	Standard Deviation 7.1
Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder	Mean Change From Baseline in Young Mania Rating Scale (YMRS) Total Score	-4.7 score on a scale	Standard Deviation 7.7

Secondary

Peak-to-Trough Percent Fluctuation (PTF%) After the Fourth Dose of 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.

Time frame: 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

Arm	Measure	Value (MEAN)	Dispersion
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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

Plasma Concentration of Aripiprazole 28 Days (C28) After the First Dose of Aripiprazole IM Depot 400 mg

Time frame: Predose on Day 29

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.

Arm	Measure	Value (MEAN)	Dispersion
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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

Plasma Concentration of Aripiprazole 56 Days (C56) After the First Dose of Aripiprazole 2M LAI 960 mg

Time frame: Predose on Day 57

Arm	Measure	Value (MEAN)	Dispersion
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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

Plasma Concentration of Aripiprazole 7 Days Post First Dose (C7) of Aripiprazole 2M LAI 960 mg

Time frame: Day 8

Arm	Measure	Value (MEAN)	Dispersion
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Plasma Concentration of Aripiprazole 7 Days Post First Dose (C7) of Aripiprazole 2M LAI 960 mg	221 ng/mL	Standard Deviation 178

Secondary

Plasma Concentration of Aripiprazole Post First Dose (C14) of Aripiprazole IM Depot 400 mg

Time frame: Day 15

Arm	Measure	Value (MEAN)	Dispersion
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	Plasma Concentration of Aripiprazole Post First Dose (C14) of Aripiprazole IM Depot 400 mg	229 ng/mL	Standard Deviation 121

Secondary

PTF% After the Eighth Dose of Aripiprazole IM Depot 400 mg

Time frame: 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

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.

Arm	Measure	Value (MEAN)	Dispersion
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	PTF% After the Eighth Dose of Aripiprazole IM Depot 400 mg	48.3 percentage fluctuation	Standard Deviation 19

Secondary

Time to Reach the Maximum Plasma Concentration (Tmax) of Aripiprazole After First and Fourth Doses of Aripiprazole 2M LAI 960 mg

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.

Arm	Measure	Group	Value (MEDIAN)
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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

Secondary

Tmax of Aripiprazole After the First, Seventh, and Eighth Doses of Aripiprazole IM Depot 400 mg

Arm	Measure	Group	Value (MEDIAN)
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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
Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder	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

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026

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

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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

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

Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Score

Mean Change From Baseline in Barnes Akathisia Rating Score (BARS) Global Score

Mean Change From Baseline in Simpson-Angus Neurologic Rating Scale (SAS) Total Score

Number of Participants With Injection Site Evaluations (Pain, Redness, Swelling, Induration) Measured by Investigator Rating After Aripiprazole 2M LAI 960 mg Injection

Number of Participants With Injection Site Evaluations (Pain, Redness, Swelling, Induration) Measured by Investigator Rating After Aripiprazole IM Depot 400 mg Injection

Number of Participants With One or More Treatment-Emergent Adverse Events (TEAEs)

Number of Participants With Potentially Clinically Relevant Clinical Laboratory Abnormalities

Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities

Number of Participants With Potentially Clinically Relevant Vital Signs Abnormalities

Number of Participants With Suicidality as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)

Plasma Concentration of Aripiprazole 28 Days Postdose (C28) of Aripiprazole IM Depot 400 mg After the Eighth Dose

Plasma Concentration of Aripiprazole 56 Days Postdose (C56) of Aripiprazole 2M LAI 960 mg After the Fourth Dose

VAS Scores for Pain Perception of Aripiprazole IM Depot 400 mg

Visual Analog Scale (VAS) Scores for Pain Perception of Aripiprazole 2M LAI 960 mg

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

AUC0-28 After the First Dose of Aripiprazole IM Depot 400 mg

AUC0-28 After the Fourth Dose of Aripiprazole 2M LAI 960 mg

AUC0-56 After the First Dose of Aripiprazole 2M LAI 960 mg

Cmax of Aripiprazole After the First, Seventh, and Eighth Doses of Aripiprazole IM Depot 400 mg

Maximum Observed Plasma Concentration (Cmax) of Aripiprazole After First and Fourth Doses of Aripiprazole 2M LAI 960 mg

Mean Change From Baseline in Clinical Global Impression - Bipolar Version (CGI-BP) Severity of Illness Score

Mean Change From Baseline in Clinical Global Impression - Improvement Scale (CGI-I) Score

Mean Change From Baseline in Clinical Global Impression - Severity Scale (CGI-S) Score

Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

Mean Change From Baseline in Positive and Negative Syndrome Scale Rating Criteria (PANSS) Total Score

Mean Change From Baseline in Subjective Well-Being Under Neuroleptic Treatment-Short Form (SWN-S) Total Score

Mean Change From Baseline in Young Mania Rating Scale (YMRS) Total Score

Peak-to-Trough Percent Fluctuation (PTF%) After the Fourth Dose of Aripiprazole 2M LAI 960 mg

Plasma Concentration of Aripiprazole 28 Days (C28) After the First Dose of Aripiprazole IM Depot 400 mg

Plasma Concentration of Aripiprazole 56 Days (C56) After the First Dose of Aripiprazole 2M LAI 960 mg

Plasma Concentration of Aripiprazole 7 Days Post First Dose (C7) of Aripiprazole 2M LAI 960 mg

Plasma Concentration of Aripiprazole Post First Dose (C14) of Aripiprazole IM Depot 400 mg

PTF% After the Eighth Dose of Aripiprazole IM Depot 400 mg

Time to Reach the Maximum Plasma Concentration (Tmax) of Aripiprazole After First and Fourth Doses of Aripiprazole 2M LAI 960 mg

Tmax of Aripiprazole After the First, Seventh, and Eighth Doses of Aripiprazole IM Depot 400 mg