Trial Outcomes & Findings for Open-label Study to Compare Hospitalization Rates of Schizophrenic Patients Treated With Oral Antipsychotics Versus IM Depot Aripiprazole (NCT NCT01432444)
NCT ID: NCT01432444
Last Updated: 2015-05-07
Results Overview
The comparison of inpatient psychiatric hospitalization rates (proportion of patients with ≥ inpatient psychiatric hospitalizations) between the retrospective period months 4-6 (Weeks-12 to -24) while on oral standard of care antipsychotic treatment and the prospective period Phase B months 4-6 (Weeks 12 to 24) after the switch to aripiprazole IM depot. Open-label Aripiprazole IM Depot Treatment Phase 3-month Completer sample comprised of all participants who entered open-label aripiprazole IM depot treatment Phase and completed at least 3 months of treatment. This sample was used for the primary endpoint analysis (N=336).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
493 participants
Primary outcome timeframe
Retrospective period Months 4-6; Prospective period Months 4-6
Results posted on
2015-05-07
Participant Flow
This study assessed hospitalization rates in adults with schizophrenia treated prospectively for 6 months with aripiprazole intramuscular depot compared with 6 month retrospective treatment with oral antipsychotics. The study comprised 3 phases: Tolerability/Cross-titration (Phase A), Open-label Aripiprazole (Phase B), Extension (Phase C).
493 participants were enrolled, 325 of which had no history of tolerating oral aripiprazole entered Phase A, all participants completed Phase A combined with remainder of participants to enter Phase B. All outcome measures were assessed in Phase B.
Participant milestones
| Measure |
Tolerability/Cross-titration Phase (Phase A)
In Phase A, participants who had no history of tolerating oral aripiprazole entered a Tolerability Assessment/Cross-titration Phase in order to assess tolerability to oral aripiprazole. The recommended initial dose of oral aripiprazole in the Tolerability Assessment/Cross-titration Phase was 10 mg or 15 mg/day, depending on the participant's symptoms and the study physician's judgment. Participants were seen in the clinic at baseline and weekly thereafter for a minimum of 1 week and maximum of 4 weeks/28 days, until tolerability to oral aripiprazole had been determined, based on physician's discretion, or until the participant was terminated from the study.
|
Open-label Aripiprazole IM Depot Treatment Phase (Phase B)
In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
|
Extension Phase (Phase C)
Participants who completed the 24-Week treatment period (Phase B), and whom the study physician believes would receive benefit from continued treatment with aripiprazole IM depot, were eligible to enter Phase C. During Phase C, participants were to continue treatment with aripiprazole IM depot until approximately 400 subjects have enrolled in Phase B (in order to achieve approximately 200 Phase B completers).
|
|---|---|---|---|
|
Tolerability/Cross-titration Phase
STARTED
|
325
|
0
|
0
|
|
Tolerability/Cross-titration Phase
COMPLETED
|
265
|
0
|
0
|
|
Tolerability/Cross-titration Phase
NOT COMPLETED
|
60
|
0
|
0
|
|
Treatment Phase
STARTED
|
0
|
433
|
0
|
|
Treatment Phase
COMPLETED
|
0
|
293
|
0
|
|
Treatment Phase
NOT COMPLETED
|
0
|
140
|
0
|
|
Extension Phase
STARTED
|
0
|
0
|
192
|
|
Extension Phase
COMPLETED
|
0
|
0
|
0
|
|
Extension Phase
NOT COMPLETED
|
0
|
0
|
192
|
Reasons for withdrawal
| Measure |
Tolerability/Cross-titration Phase (Phase A)
In Phase A, participants who had no history of tolerating oral aripiprazole entered a Tolerability Assessment/Cross-titration Phase in order to assess tolerability to oral aripiprazole. The recommended initial dose of oral aripiprazole in the Tolerability Assessment/Cross-titration Phase was 10 mg or 15 mg/day, depending on the participant's symptoms and the study physician's judgment. Participants were seen in the clinic at baseline and weekly thereafter for a minimum of 1 week and maximum of 4 weeks/28 days, until tolerability to oral aripiprazole had been determined, based on physician's discretion, or until the participant was terminated from the study.
|
Open-label Aripiprazole IM Depot Treatment Phase (Phase B)
In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
|
Extension Phase (Phase C)
Participants who completed the 24-Week treatment period (Phase B), and whom the study physician believes would receive benefit from continued treatment with aripiprazole IM depot, were eligible to enter Phase C. During Phase C, participants were to continue treatment with aripiprazole IM depot until approximately 400 subjects have enrolled in Phase B (in order to achieve approximately 200 Phase B completers).
|
|---|---|---|---|
|
Tolerability/Cross-titration Phase
Lost to Follow-up
|
10
|
0
|
0
|
|
Tolerability/Cross-titration Phase
Adverse Event
|
16
|
0
|
0
|
|
Tolerability/Cross-titration Phase
Met Withdrawal Criteria
|
5
|
0
|
0
|
|
Tolerability/Cross-titration Phase
Physician Decision
|
8
|
0
|
0
|
|
Tolerability/Cross-titration Phase
Withdrawal by Subject
|
15
|
0
|
0
|
|
Tolerability/Cross-titration Phase
Protocol Deviation
|
1
|
0
|
0
|
|
Tolerability/Cross-titration Phase
Lack of Efficacy
|
5
|
0
|
0
|
|
Treatment Phase
Lost to Follow-up
|
0
|
33
|
0
|
|
Treatment Phase
Adverse Event
|
0
|
37
|
0
|
|
Treatment Phase
Met Withdrawal Criteria
|
0
|
11
|
0
|
|
Treatment Phase
Physician Decision
|
0
|
5
|
0
|
|
Treatment Phase
Withdrawal by Subject
|
0
|
41
|
0
|
|
Treatment Phase
Protocol Deviation
|
0
|
3
|
0
|
|
Treatment Phase
Lack of Efficacy
|
0
|
10
|
0
|
|
Extension Phase
Lost to Follow-up
|
0
|
0
|
17
|
|
Extension Phase
Adverse Event
|
0
|
0
|
10
|
|
Extension Phase
Sponsor Discontinued Trial
|
0
|
0
|
7
|
|
Extension Phase
Met Withdrawal Criteria
|
0
|
0
|
144
|
|
Extension Phase
Physician Decision
|
0
|
0
|
1
|
|
Extension Phase
Withdrawal by Subject
|
0
|
0
|
13
|
Baseline Characteristics
Open-label Study to Compare Hospitalization Rates of Schizophrenic Patients Treated With Oral Antipsychotics Versus IM Depot Aripiprazole
Baseline characteristics by cohort
| Measure |
Open-label Aripiprazole IM Depot Treatment Phase (Phase B)
n=433 Participants
In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
|
|---|---|
|
Age, Continuous
|
42.1 Years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
132 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
301 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Retrospective period Months 4-6; Prospective period Months 4-6Population: The core dataset for all efficacy analyses is the Intent-to-Treat (ITT) dataset which consisted of data from all participants who entered Phase B regardless of receiving a dose in the Open-label Aripiprazole IM Depot Treatment Phase.
The comparison of inpatient psychiatric hospitalization rates (proportion of patients with ≥ inpatient psychiatric hospitalizations) between the retrospective period months 4-6 (Weeks-12 to -24) while on oral standard of care antipsychotic treatment and the prospective period Phase B months 4-6 (Weeks 12 to 24) after the switch to aripiprazole IM depot. Open-label Aripiprazole IM Depot Treatment Phase 3-month Completer sample comprised of all participants who entered open-label aripiprazole IM depot treatment Phase and completed at least 3 months of treatment. This sample was used for the primary endpoint analysis (N=336).
Outcome measures
| Measure |
Open-label Aripiprazole IM Depot Treatment Phase (Phase B)
n=336 Participants
In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
|
|---|---|
|
Number of Inpatient Psychiatric Hospitalization for Retrospective Period (Months 4-6) and Prospective Period (Months 4-6).
Retrospective period
|
91 participants
0.6
|
|
Number of Inpatient Psychiatric Hospitalization for Retrospective Period (Months 4-6) and Prospective Period (Months 4-6).
Prospective period
|
9 participants
0.2
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: The core dataset for all efficacy analyses is the ITT dataset which consisted of data from all participants who entered Phase B regardless of receiving a dose in the Open-label Aripiprazole IM Depot Treatment Phase.
The PANSS consists of three subscales with a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicates (absence of symptoms) and a score of 7 indicates (extremely severe symptoms). The symptom constructs for each subscale are as follows: 7 Positive subscale symptom constructs, 7 Negative subscale symptom constructs and 16 General Psychopathology subscale symptom constructs. The PANSS total score ranges from 30 to 210.
Outcome measures
| Measure |
Open-label Aripiprazole IM Depot Treatment Phase (Phase B)
n=427 Participants
In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
|
|---|---|
|
Change From Baseline in PANSS (Positive and Negative Syndrome Scale) Total Score.
Week 4 (N= 390)
|
-7.9 Units on a scale
Standard Deviation 14.0
|
|
Change From Baseline in PANSS (Positive and Negative Syndrome Scale) Total Score.
Week 12 (N= 410)
|
-8.4 Units on a scale
Standard Deviation 15.6
|
|
Change From Baseline in PANSS (Positive and Negative Syndrome Scale) Total Score.
Week 24 (N= 410)
|
-8.4 Units on a scale
Standard Deviation 17.7
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: The core dataset for all efficacy analyses is the ITT dataset which consisted of data from all participants who entered Phase B regardless of receiving a dose in the Open-label Aripiprazole IM Depot Treatment Phase.
The PANSS consists of three subscales with a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicates (absence of symptoms) and a score of 7 indicates (extremely severe symptoms). The symptom constructs for each subscale are as follows: 7 Positive subscale symptom constructs, 7 Negative subscale symptom constructs and 16 General Psychopathology subscale symptom constructs. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity suspiciousness/ persecution, and hostility. The PANSS Positive Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).
Outcome measures
| Measure |
Open-label Aripiprazole IM Depot Treatment Phase (Phase B)
n=427 Participants
In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
|
|---|---|
|
Change From Baseline in PANSS Positive Subscale Score.
Week 4 (N= 390)
|
-2.7 Units on a scale
Standard Deviation 4.4
|
|
Change From Baseline in PANSS Positive Subscale Score.
Week 12 (N= 410)
|
-2.9 Units on a scale
Standard Deviation 4.9
|
|
Change From Baseline in PANSS Positive Subscale Score.
Week 24 (N= 410)
|
-3.0 Units on a scale
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: The core dataset for all efficacy analyses is the ITT dataset which consisted of data from all participants who entered Phase B regardless of receiving a dose in the Open-label Aripiprazole IM Depot Treatment Phase.
The PANSS consists of three subscales with a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicates (absence of symptoms) and a score of 7 indicates (extremely severe symptoms). The symptom constructs for each subscale are as follows: 7 Positive subscale symptom constructs, 7 Negative subscale symptom constructs and 16 General Psychopathology subscale symptom constructs. The 7 negative symptom constructs are blunted affect, emotional withdrawal, poor rapport, passive pathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS Negative Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).
Outcome measures
| Measure |
Open-label Aripiprazole IM Depot Treatment Phase (Phase B)
n=427 Participants
In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
|
|---|---|
|
Change From Baseline in PANSS Negative Subscale Score.
Week 4
|
-1.7 Units on a scale
Standard Deviation 4.6
|
|
Change From Baseline in PANSS Negative Subscale Score.
Week 12
|
-1.6 Units on a scale
Standard Deviation 5.1
|
|
Change From Baseline in PANSS Negative Subscale Score.
Week 24
|
-1.6 Units on a scale
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: The core dataset for all efficacy analyses is the ITT dataset which consisted of data from all participants who entered Phase B regardless of receiving a dose in the Open-label Aripiprazole IM Depot Treatment Phase.
The severity of illness for each participant were rated using the CGI-S scale. To assess CGI-S, study physician were to answer the following question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" Response choices included: 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 patients.
Outcome measures
| Measure |
Open-label Aripiprazole IM Depot Treatment Phase (Phase B)
n=425 Participants
In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
|
|---|---|
|
Change From Baseline in Clinical Global Impression-Severity Score (CGI-S).
Week 4 (N= 391)
|
-0.3 Units on a scale
Standard Deviation 0.8
|
|
Change From Baseline in Clinical Global Impression-Severity Score (CGI-S).
Week 12 (N= 410)
|
-0.4 Units on a scale
Standard Deviation 0.9
|
|
Change From Baseline in Clinical Global Impression-Severity Score (CGI-S).
Week 24 (N= 410)
|
-0.5 Units on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Week 4, 12 and 24Population: The core dataset for all efficacy analyses is the ITT dataset which consisted of data from all participants who entered Phase B regardless of receiving a dose in the Open-label Aripiprazole IM Depot Treatment Phase.
The efficacy of trial medication was rated for each participant using the CGI-I scale. The study physician would rate the participants total improvement whether or not it was entirely due to drug treatment. All responses were compared to the participants condition at Baseline of the appropriate phase. The CGI-I during Phase B were assessed relative to the participants condition at the Phase B Baseline visit. Response choices included: 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.
Outcome measures
| Measure |
Open-label Aripiprazole IM Depot Treatment Phase (Phase B)
n=425 Participants
In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
|
|---|---|
|
Mean Clinical Global Impression-Improvement Score (CGI-I) by Week.
Week 4 (N= 283)
|
2.9 Units on a scale
Standard Deviation 0.9
|
|
Mean Clinical Global Impression-Improvement Score (CGI-I) by Week.
Week 12 (N= 293)
|
2.7 Units on a scale
Standard Deviation 1.0
|
|
Mean Clinical Global Impression-Improvement Score (CGI-I) by Week.
Week 24 (N= 293)
|
2.5 Units on a scale
Standard Deviation 1.0
|
Adverse Events
Open-label Aripiprazole IM Depot Treatment Phase (Phase B)
Serious events: 61 serious events
Other events: 60 other events
Deaths: 0 deaths
Extension Phase (Phase C)
Serious events: 19 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Open-label Aripiprazole IM Depot Treatment Phase (Phase B)
n=431 participants at risk
In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
|
Extension Phase (Phase C)
n=192 participants at risk
Participants who completed the 24-Week treatment period (Phase B), and whom the study physician believed would benefit from continued treatment with aripiprazole IM depot, were eligible to enter Phase C. During Phase C, participants were to continue treatment with aripiprazole IM depot until approximately 400 subjects have enrolled in Phase B (in order to achieve approximately 200 Phase B completers).
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.23%
1/431 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
0.00%
0/192 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/431 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
0.52%
1/192 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/431 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
0.52%
1/192 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
|
Cardiac disorders
Myocardial infarction
|
0.23%
1/431 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
0.00%
0/192 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
|
Cardiac disorders
Sinus tachycardia
|
0.23%
1/431 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
0.00%
0/192 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.23%
1/431 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
0.00%
0/192 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
|
General disorders
Asthenia
|
0.23%
1/431 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
0.00%
0/192 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
|
General disorders
Chest pain
|
0.23%
1/431 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
0.00%
0/192 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
|
General disorders
Non-cardiac chest pain
|
0.23%
1/431 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
0.00%
0/192 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.23%
1/431 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
0.00%
0/192 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/431 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
0.52%
1/192 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
|
Infections and infestations
Lobar pneumonia
|
0.23%
1/431 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
0.00%
0/192 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
|
Infections and infestations
Pneumonia
|
0.23%
1/431 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
0.00%
0/192 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.46%
2/431 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
0.00%
0/192 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.23%
1/431 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
0.00%
0/192 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
|
Investigations
Blood glucose increased
|
0.23%
1/431 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
0.00%
0/192 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.23%
1/431 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
0.00%
0/192 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.23%
1/431 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
0.00%
0/192 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.23%
1/431 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
0.00%
0/192 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.23%
1/431 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
0.00%
0/192 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.23%
1/431 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
0.00%
0/192 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
|
Metabolism and nutrition disorders
Type 2 diabetis mellitus
|
0.23%
1/431 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
0.52%
1/192 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.46%
2/431 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
0.00%
0/192 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.23%
1/431 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
0.00%
0/192 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
|
Nervous system disorders
Akathisia
|
0.23%
1/431 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
0.00%
0/192 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
|
Nervous system disorders
Convulsion
|
0.93%
4/431 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
0.52%
1/192 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.00%
0/431 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
0.52%
1/192 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
|
Nervous system disorders
Sedation
|
0.23%
1/431 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
0.00%
0/192 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.46%
2/431 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
0.00%
0/192 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
|
Psychiatric disorders
Acute psychosis
|
0.23%
1/431 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
0.00%
0/192 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
|
Psychiatric disorders
Anxiety
|
0.23%
1/431 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
0.00%
0/192 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
|
Psychiatric disorders
Depression
|
0.46%
2/431 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
0.52%
1/192 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
|
Psychiatric disorders
Psychotic disorder
|
1.9%
8/431 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
1.6%
3/192 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
|
Psychiatric disorders
Schizophrenia
|
2.6%
11/431 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
3.1%
6/192 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
|
Psychiatric disorders
Schizophrenia, paranoid type
|
3.2%
14/431 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
1.6%
3/192 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
|
Psychiatric disorders
Schizophrenia, undifferentiated type
|
0.00%
0/431 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
0.52%
1/192 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
|
Psychiatric disorders
Suicidal ideation
|
1.4%
6/431 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
0.52%
1/192 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
|
Psychiatric disorders
Suicide attempt
|
0.70%
3/431 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
0.52%
1/192 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
|
Reproductive system and breast disorders
Penile oedema
|
0.23%
1/431 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
0.00%
0/192 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.23%
1/431 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
0.00%
0/192 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.23%
1/431 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
0.00%
0/192 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/431 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
0.52%
1/192 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.23%
1/431 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
0.00%
0/192 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
|
Vascular disorders
Hypertension
|
0.46%
2/431 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
0.00%
0/192 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
Other adverse events
| Measure |
Open-label Aripiprazole IM Depot Treatment Phase (Phase B)
n=431 participants at risk
In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
|
Extension Phase (Phase C)
n=192 participants at risk
Participants who completed the 24-Week treatment period (Phase B), and whom the study physician believed would benefit from continued treatment with aripiprazole IM depot, were eligible to enter Phase C. During Phase C, participants were to continue treatment with aripiprazole IM depot until approximately 400 subjects have enrolled in Phase B (in order to achieve approximately 200 Phase B completers).
|
|---|---|---|
|
Nervous system disorders
Akathisia
|
6.3%
27/431 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
4.7%
9/192 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
|
Psychiatric disorders
Insomnia
|
6.7%
29/431 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
3.1%
6/192 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
|
Investigations
Weight increased
|
2.3%
10/431 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
5.7%
11/192 • Adverse events were monitored from ICF signed until Follow-up 30 (± 3) days after last visit.
431 participants who had received at least one dose of study medication in the corresponding trial phase were included in the safety analysis.
|
Additional Information
Global Medical Affairs
Otsuka Pharmaceutical Development and Commercialization, Inc.
Phone: 800 562-3974
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place