Trial Outcomes & Findings for Trial of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in the Acute Treatment of Adults With Schizophrenia (NCT NCT01663532)
NCT ID: NCT01663532
Last Updated: 2015-02-16
Results Overview
The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 that indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. The PANSS total score was the sum of the rating scores for 7 positive subscale items, 7 negative subscale items, and 16 general psychopathology subscale items from the PANSS panel. PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome). The primary statistical comparison was performed using the Mixed Model Repeated Measure (MMRM) approach.
COMPLETED
PHASE3
340 participants
Baseline to Week 10
2015-02-16
Participant Flow
The trial was a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of aripiprazole IM (intramuscular) depot as treatment for an acute episode of schizophrenia in adult participants. The trial was conducted in 55 sites.
This trial included a 13-Day Screening phase (which includes Washout from previous antipsychotics for 7 days and/or washout from other prohibited medications), a 12-Week acute treatment phase, and a 14 (±2) Day safety follow-up.
Participant milestones
| Measure |
Aripiprazole IM Depot 400/300mg
Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
|
Placebo
Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
|
|---|---|---|
|
Overall Study
STARTED
|
168
|
172
|
|
Overall Study
COMPLETED
|
94
|
65
|
|
Overall Study
NOT COMPLETED
|
74
|
107
|
Reasons for withdrawal
| Measure |
Aripiprazole IM Depot 400/300mg
Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
|
Placebo
Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
9
|
10
|
|
Overall Study
Adverse Event
|
7
|
13
|
|
Overall Study
Met Withdrawal Criteria
|
7
|
6
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
35
|
17
|
|
Overall Study
Lack of Efficacy
|
15
|
60
|
Baseline Characteristics
Trial of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in the Acute Treatment of Adults With Schizophrenia
Baseline characteristics by cohort
| Measure |
Aripiprazole IM Depot 400/300mg
n=168 Participants
Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
|
Placebo
n=172 Participants
Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
|
Total
n=340 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.1 Years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
42.7 Years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
42.4 Years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
130 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
269 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 10Population: Efficacy sample was defined as the intent to treat (ITT) population which included randomized participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had at least one Post-Baseline efficacy assessment. Data of only 162 and 167 participants from aripiprazole and placebo groups were available.
The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 that indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. The PANSS total score was the sum of the rating scores for 7 positive subscale items, 7 negative subscale items, and 16 general psychopathology subscale items from the PANSS panel. PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome). The primary statistical comparison was performed using the Mixed Model Repeated Measure (MMRM) approach.
Outcome measures
| Measure |
Aripiprazole IM Depot 400/300mg
n=162 Participants
Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
|
Placebo
n=167 Participants
Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
|
|---|---|---|
|
Mean Change From Baseline to Endpoint in Positive and Negative Syndrome Scale (PANSS) Total Score.
Week 1 (N= 162, 167)
|
-8.9 Units on a scale
Standard Error 0.9
|
-5.0 Units on a scale
Standard Error 0.9
|
|
Mean Change From Baseline to Endpoint in Positive and Negative Syndrome Scale (PANSS) Total Score.
Week 2 (N= 144, 157)
|
-15.2 Units on a scale
Standard Error 1.2
|
-8.3 Units on a scale
Standard Error 1.2
|
|
Mean Change From Baseline to Endpoint in Positive and Negative Syndrome Scale (PANSS) Total Score.
Week 4 (N= 134, 140)
|
-19.0 Units on a scale
Standard Error 1.4
|
-9.8 Units on a scale
Standard Error 1.3
|
|
Mean Change From Baseline to Endpoint in Positive and Negative Syndrome Scale (PANSS) Total Score.
Week 6 (N= 126, 117)
|
-21.5 Units on a scale
Standard Error 1.5
|
-10.3 Units on a scale
Standard Error 1.5
|
|
Mean Change From Baseline to Endpoint in Positive and Negative Syndrome Scale (PANSS) Total Score.
Week 8 (N= 108, 96)
|
-23.7 Units on a scale
Standard Error 1.6
|
-9.7 Units on a scale
Standard Error 1.6
|
|
Mean Change From Baseline to Endpoint in Positive and Negative Syndrome Scale (PANSS) Total Score.
Week 10 (N= 99, 81)
|
-26.8 Units on a scale
Standard Error 1.6
|
-11.7 Units on a scale
Standard Error 1.6
|
SECONDARY outcome
Timeframe: Baseline to Week 10Population: Efficacy sample was defined as the intent to treat (ITT) population which included randomized participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had at least one Post-Baseline efficacy assessment. Data of only 162 and 168 participants from aripiprazole and placebo groups were available.
The severity of illness for each participants were rated using the CGI-S scale. The study physician were to answer the following question: "Considering your total experience with this particular population, how mentally ill is the patient at this time?" Response choices included were: 0= not assessed; 1= normal; not at all ill; 2= borderline mentally ill; 3= mildly ill; 4= moderately ill; 5= markedly ill; 6= severely ill; and 7= among the most extremely ill participants.
Outcome measures
| Measure |
Aripiprazole IM Depot 400/300mg
n=162 Participants
Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
|
Placebo
n=168 Participants
Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
|
|---|---|---|
|
Mean Change From Baseline to Endpoint in Clinical Global Impression-Severity Scale (CGI-S) Score.
Week 1 (N= 162, 168)
|
-0.4 Units on a scale
Standard Error 0.1
|
-0.2 Units on a scale
Standard Error 0.1
|
|
Mean Change From Baseline to Endpoint in Clinical Global Impression-Severity Scale (CGI-S) Score.
Week 2 (N= 144, 157)
|
-0.8 Units on a scale
Standard Error 0.1
|
-0.4 Units on a scale
Standard Error 0.1
|
|
Mean Change From Baseline to Endpoint in Clinical Global Impression-Severity Scale (CGI-S) Score.
Week 4 (N= 134, 140)
|
-1.0 Units on a scale
Standard Error 0.1
|
-0.4 Units on a scale
Standard Error 0.1
|
|
Mean Change From Baseline to Endpoint in Clinical Global Impression-Severity Scale (CGI-S) Score.
Week 6 (N= 126, 117)
|
-1.2 Units on a scale
Standard Error 0.1
|
-0.5 Units on a scale
Standard Error 0.1
|
|
Mean Change From Baseline to Endpoint in Clinical Global Impression-Severity Scale (CGI-S) Score.
Week 8 (N= 108, 96)
|
-1.3 Units on a scale
Standard Error 0.1
|
-0.6 Units on a scale
Standard Error 0.1
|
|
Mean Change From Baseline to Endpoint in Clinical Global Impression-Severity Scale (CGI-S) Score.
Week 10 (N= 99, 81)
|
-1.4 Units on a scale
Standard Error 0.1
|
-0.6 Units on a scale
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Baseline to Week 10Population: Efficacy sample was defined as the intent to treat (ITT) population which included randomized participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had at least one Post-Baseline efficacy assessment. Data of only 162 and 167 participants from aripiprazole and placebo groups were available.
The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In positive subscale, the 7 positive symptom constructs were: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. PANSS Positive Subscale Score ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).
Outcome measures
| Measure |
Aripiprazole IM Depot 400/300mg
n=162 Participants
Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
|
Placebo
n=167 Participants
Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
|
|---|---|---|
|
Mean Change From Baseline to Endpoint in PANSS Positive Subscale Score.
Week 1 (N= 162, 167)
|
-3.5 Units on a scale
Standard Error 0.3
|
-2.1 Units on a scale
Standard Error 0.3
|
|
Mean Change From Baseline to Endpoint in PANSS Positive Subscale Score.
Week 2 (N= 144, 157)
|
-5.7 Units on a scale
Standard Error 0.4
|
-3.4 Units on a scale
Standard Error 0.4
|
|
Mean Change From Baseline to Endpoint in PANSS Positive Subscale Score.
Week 4 (N= 134, 140)
|
-7.0 Units on a scale
Standard Error 0.5
|
-3.9 Units on a scale
Standard Error 0.4
|
|
Mean Change From Baseline to Endpoint in PANSS Positive Subscale Score.
Week 6 (N= 126, 117)
|
-8.2 Units on a scale
Standard Error 0.5
|
-4.4 Units on a scale
Standard Error 0.5
|
|
Mean Change From Baseline to Endpoint in PANSS Positive Subscale Score.
Week 8 (N= 108, 96)
|
-8.9 Units on a scale
Standard Error 0.5
|
-4.1 Units on a scale
Standard Error 0.5
|
|
Mean Change From Baseline to Endpoint in PANSS Positive Subscale Score.
Week 10 (N= 99, 81)
|
-10.0 Units on a scale
Standard Error 0.5
|
-4.9 Units on a scale
Standard Error 0.5
|
SECONDARY outcome
Timeframe: Baseline to Week 10Population: Efficacy sample was defined as the intent to treat (ITT) population which included randomized participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had at least one Post-Baseline efficacy assessment. Data of only 162 and 167 participants from aripiprazole and placebo groups were available.
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 indicated- absence of symptoms and a score of 7 indicated- extremely severe symptoms. The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs were: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation and stereotyped thinking. PANSS Negative Subscale Score ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).
Outcome measures
| Measure |
Aripiprazole IM Depot 400/300mg
n=162 Participants
Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
|
Placebo
n=167 Participants
Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
|
|---|---|---|
|
Mean Change From Baseline to Endpoint in PANSS Negative Subscale Score.
Week 1 (N= 162, 167)
|
-1.6 Units on a scale
Standard Error 0.2
|
-0.7 Units on a scale
Standard Error 0.2
|
|
Mean Change From Baseline to Endpoint in PANSS Negative Subscale Score.
Week 2 (N= 144, 157)
|
-2.4 Units on a scale
Standard Error 0.3
|
-1.2 Units on a scale
Standard Error 0.3
|
|
Mean Change From Baseline to Endpoint in PANSS Negative Subscale Score.
Week 4 (N= 134, 140)
|
-3.1 Units on a scale
Standard Error 0.4
|
-1.3 Units on a scale
Standard Error 0.4
|
|
Mean Change From Baseline to Endpoint in PANSS Negative Subscale Score.
Week 6 (N= 126, 117)
|
-3.5 Units on a scale
Standard Error 0.4
|
-1.3 Units on a scale
Standard Error 0.4
|
|
Mean Change From Baseline to Endpoint in PANSS Negative Subscale Score.
Week 8 (N= 108, 96)
|
-4.0 Units on a scale
Standard Error 0.4
|
-1.4 Units on a scale
Standard Error 0.4
|
|
Mean Change From Baseline to Endpoint in PANSS Negative Subscale Score.
Week 10 (N= 99, 81)
|
-4.5 Units on a scale
Standard Error 0.5
|
-1.6 Units on a scale
Standard Error 0.5
|
SECONDARY outcome
Timeframe: Week 10Population: Efficacy sample included participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had one Post-Baseline efficacy assessment. LOCF was used to impute the missing data with the recorded value obtained at the preceding visit.
The PSP was a validated clinician scale that measured personal and social functionining in 4 domains: socially useful activities eg, work and study), personal and social relationships, self-care, disturbing and aggressive behaviours. Impairement in each of these domains was rated as absent, mild, manifest, marked, severe, or very severe. These ratings were then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval and the study physician's judgement to determine the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 were considered to have mild functional difficulty. Scores of 31 to 70 represented varying degrees of disability (31 to 70) and ratings of 1 to 30 indicated minimal functioning that required intense support and/or supervision.
Outcome measures
| Measure |
Aripiprazole IM Depot 400/300mg
n=139 Participants
Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
|
Placebo
n=146 Participants
Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
|
|---|---|---|
|
Mean Change From Baseline to Endpoint in Personal and Social Performance Scale (PSP) Score.
|
12.3 Units on a scale
Standard Error 1.2
|
5.2 Units on a scale
Standard Error 1.2
|
SECONDARY outcome
Timeframe: Week 10Population: Efficacy sample was defined as the ITT population which included randomized participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had at least one Post-Baseline efficacy assessment. LOCF was used to impute the missing data with the recorded value obtained at the preceding visit.
The severity of illness for each participants were rated using the CGI-S scale. The study physician were to answer the following question: "Considering your total experience with this particular population, how mentally ill is the patient at this time?" Response choices included were: 0= not assessed; 1= normal; not at all ill; 2= borderline mentally ill; 3= mildly ill; 4= moderately ill; 5= markedly ill; 6= severely ill; and 7= among the most extremely ill participants.
Outcome measures
| Measure |
Aripiprazole IM Depot 400/300mg
n=162 Participants
Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
|
Placebo
n=168 Participants
Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
|
|---|---|---|
|
Mean Clinical Global Impression-Improvement Scale (CGI-I) Score at Endpoint.
|
2.7 Units on a scale
Standard Deviation 1.2
|
3.7 Units on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Week 10Population: Efficacy sample was defined as the ITT population which included randomized participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had at least one Post-Baseline efficacy assessment. LOCF was used to impute the missing data with the recorded value obtained at the preceding visit.
Responder rate was defined as ≥30% reduction from Baseline in PANSS Total Score. PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome).
Outcome measures
| Measure |
Aripiprazole IM Depot 400/300mg
n=162 Participants
Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
|
Placebo
n=168 Participants
Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
|
|---|---|---|
|
Responder Rate Based on PANSS Total Score.
|
60 participants
|
24 participants
|
Adverse Events
Aripiprazole IM Depot 400/300mg
Placebo
Serious adverse events
| Measure |
Aripiprazole IM Depot 400/300mg
n=167 participants at risk
Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
|
Placebo
n=172 participants at risk
Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.60%
1/167 • Adverse events were monitored from ICF signed untill Follow-up 14 (± 2) days.
One participant was randomly assigned to aripiprazole IM depot 400 mg/ 300 mg, but was not treated and did not have any post-randomization assessments and was not included in safety or efficacy assessments.
|
0.00%
0/172 • Adverse events were monitored from ICF signed untill Follow-up 14 (± 2) days.
One participant was randomly assigned to aripiprazole IM depot 400 mg/ 300 mg, but was not treated and did not have any post-randomization assessments and was not included in safety or efficacy assessments.
|
|
Psychiatric disorders
Agitation
|
0.60%
1/167 • Adverse events were monitored from ICF signed untill Follow-up 14 (± 2) days.
One participant was randomly assigned to aripiprazole IM depot 400 mg/ 300 mg, but was not treated and did not have any post-randomization assessments and was not included in safety or efficacy assessments.
|
0.00%
0/172 • Adverse events were monitored from ICF signed untill Follow-up 14 (± 2) days.
One participant was randomly assigned to aripiprazole IM depot 400 mg/ 300 mg, but was not treated and did not have any post-randomization assessments and was not included in safety or efficacy assessments.
|
|
Psychiatric disorders
Psychotic disorder
|
1.2%
2/167 • Adverse events were monitored from ICF signed untill Follow-up 14 (± 2) days.
One participant was randomly assigned to aripiprazole IM depot 400 mg/ 300 mg, but was not treated and did not have any post-randomization assessments and was not included in safety or efficacy assessments.
|
1.2%
2/172 • Adverse events were monitored from ICF signed untill Follow-up 14 (± 2) days.
One participant was randomly assigned to aripiprazole IM depot 400 mg/ 300 mg, but was not treated and did not have any post-randomization assessments and was not included in safety or efficacy assessments.
|
|
Psychiatric disorders
Schizophrenia
|
1.8%
3/167 • Adverse events were monitored from ICF signed untill Follow-up 14 (± 2) days.
One participant was randomly assigned to aripiprazole IM depot 400 mg/ 300 mg, but was not treated and did not have any post-randomization assessments and was not included in safety or efficacy assessments.
|
1.7%
3/172 • Adverse events were monitored from ICF signed untill Follow-up 14 (± 2) days.
One participant was randomly assigned to aripiprazole IM depot 400 mg/ 300 mg, but was not treated and did not have any post-randomization assessments and was not included in safety or efficacy assessments.
|
|
Psychiatric disorders
Substance abuse
|
0.60%
1/167 • Adverse events were monitored from ICF signed untill Follow-up 14 (± 2) days.
One participant was randomly assigned to aripiprazole IM depot 400 mg/ 300 mg, but was not treated and did not have any post-randomization assessments and was not included in safety or efficacy assessments.
|
0.00%
0/172 • Adverse events were monitored from ICF signed untill Follow-up 14 (± 2) days.
One participant was randomly assigned to aripiprazole IM depot 400 mg/ 300 mg, but was not treated and did not have any post-randomization assessments and was not included in safety or efficacy assessments.
|
|
Psychiatric disorders
Suicidal ideation
|
0.60%
1/167 • Adverse events were monitored from ICF signed untill Follow-up 14 (± 2) days.
One participant was randomly assigned to aripiprazole IM depot 400 mg/ 300 mg, but was not treated and did not have any post-randomization assessments and was not included in safety or efficacy assessments.
|
0.00%
0/172 • Adverse events were monitored from ICF signed untill Follow-up 14 (± 2) days.
One participant was randomly assigned to aripiprazole IM depot 400 mg/ 300 mg, but was not treated and did not have any post-randomization assessments and was not included in safety or efficacy assessments.
|
|
Vascular disorders
Hypotension
|
0.00%
0/167 • Adverse events were monitored from ICF signed untill Follow-up 14 (± 2) days.
One participant was randomly assigned to aripiprazole IM depot 400 mg/ 300 mg, but was not treated and did not have any post-randomization assessments and was not included in safety or efficacy assessments.
|
0.58%
1/172 • Adverse events were monitored from ICF signed untill Follow-up 14 (± 2) days.
One participant was randomly assigned to aripiprazole IM depot 400 mg/ 300 mg, but was not treated and did not have any post-randomization assessments and was not included in safety or efficacy assessments.
|
Other adverse events
| Measure |
Aripiprazole IM Depot 400/300mg
n=167 participants at risk
Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
|
Placebo
n=172 participants at risk
Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
9.6%
16/167 • Adverse events were monitored from ICF signed untill Follow-up 14 (± 2) days.
One participant was randomly assigned to aripiprazole IM depot 400 mg/ 300 mg, but was not treated and did not have any post-randomization assessments and was not included in safety or efficacy assessments.
|
7.0%
12/172 • Adverse events were monitored from ICF signed untill Follow-up 14 (± 2) days.
One participant was randomly assigned to aripiprazole IM depot 400 mg/ 300 mg, but was not treated and did not have any post-randomization assessments and was not included in safety or efficacy assessments.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.0%
10/167 • Adverse events were monitored from ICF signed untill Follow-up 14 (± 2) days.
One participant was randomly assigned to aripiprazole IM depot 400 mg/ 300 mg, but was not treated and did not have any post-randomization assessments and was not included in safety or efficacy assessments.
|
6.4%
11/172 • Adverse events were monitored from ICF signed untill Follow-up 14 (± 2) days.
One participant was randomly assigned to aripiprazole IM depot 400 mg/ 300 mg, but was not treated and did not have any post-randomization assessments and was not included in safety or efficacy assessments.
|
|
Gastrointestinal disorders
Toothache
|
5.4%
9/167 • Adverse events were monitored from ICF signed untill Follow-up 14 (± 2) days.
One participant was randomly assigned to aripiprazole IM depot 400 mg/ 300 mg, but was not treated and did not have any post-randomization assessments and was not included in safety or efficacy assessments.
|
4.7%
8/172 • Adverse events were monitored from ICF signed untill Follow-up 14 (± 2) days.
One participant was randomly assigned to aripiprazole IM depot 400 mg/ 300 mg, but was not treated and did not have any post-randomization assessments and was not included in safety or efficacy assessments.
|
|
General disorders
Injection site pain
|
5.4%
9/167 • Adverse events were monitored from ICF signed untill Follow-up 14 (± 2) days.
One participant was randomly assigned to aripiprazole IM depot 400 mg/ 300 mg, but was not treated and did not have any post-randomization assessments and was not included in safety or efficacy assessments.
|
0.58%
1/172 • Adverse events were monitored from ICF signed untill Follow-up 14 (± 2) days.
One participant was randomly assigned to aripiprazole IM depot 400 mg/ 300 mg, but was not treated and did not have any post-randomization assessments and was not included in safety or efficacy assessments.
|
|
Investigations
Weight increased
|
16.8%
28/167 • Adverse events were monitored from ICF signed untill Follow-up 14 (± 2) days.
One participant was randomly assigned to aripiprazole IM depot 400 mg/ 300 mg, but was not treated and did not have any post-randomization assessments and was not included in safety or efficacy assessments.
|
7.0%
12/172 • Adverse events were monitored from ICF signed untill Follow-up 14 (± 2) days.
One participant was randomly assigned to aripiprazole IM depot 400 mg/ 300 mg, but was not treated and did not have any post-randomization assessments and was not included in safety or efficacy assessments.
|
|
Nervous system disorders
Akathisia
|
11.4%
19/167 • Adverse events were monitored from ICF signed untill Follow-up 14 (± 2) days.
One participant was randomly assigned to aripiprazole IM depot 400 mg/ 300 mg, but was not treated and did not have any post-randomization assessments and was not included in safety or efficacy assessments.
|
3.5%
6/172 • Adverse events were monitored from ICF signed untill Follow-up 14 (± 2) days.
One participant was randomly assigned to aripiprazole IM depot 400 mg/ 300 mg, but was not treated and did not have any post-randomization assessments and was not included in safety or efficacy assessments.
|
|
Nervous system disorders
Headache
|
14.4%
24/167 • Adverse events were monitored from ICF signed untill Follow-up 14 (± 2) days.
One participant was randomly assigned to aripiprazole IM depot 400 mg/ 300 mg, but was not treated and did not have any post-randomization assessments and was not included in safety or efficacy assessments.
|
16.3%
28/172 • Adverse events were monitored from ICF signed untill Follow-up 14 (± 2) days.
One participant was randomly assigned to aripiprazole IM depot 400 mg/ 300 mg, but was not treated and did not have any post-randomization assessments and was not included in safety or efficacy assessments.
|
|
Nervous system disorders
Sedation
|
5.4%
9/167 • Adverse events were monitored from ICF signed untill Follow-up 14 (± 2) days.
One participant was randomly assigned to aripiprazole IM depot 400 mg/ 300 mg, but was not treated and did not have any post-randomization assessments and was not included in safety or efficacy assessments.
|
1.2%
2/172 • Adverse events were monitored from ICF signed untill Follow-up 14 (± 2) days.
One participant was randomly assigned to aripiprazole IM depot 400 mg/ 300 mg, but was not treated and did not have any post-randomization assessments and was not included in safety or efficacy assessments.
|
|
Psychiatric disorders
Agitation
|
5.4%
9/167 • Adverse events were monitored from ICF signed untill Follow-up 14 (± 2) days.
One participant was randomly assigned to aripiprazole IM depot 400 mg/ 300 mg, but was not treated and did not have any post-randomization assessments and was not included in safety or efficacy assessments.
|
6.4%
11/172 • Adverse events were monitored from ICF signed untill Follow-up 14 (± 2) days.
One participant was randomly assigned to aripiprazole IM depot 400 mg/ 300 mg, but was not treated and did not have any post-randomization assessments and was not included in safety or efficacy assessments.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.0%
10/167 • Adverse events were monitored from ICF signed untill Follow-up 14 (± 2) days.
One participant was randomly assigned to aripiprazole IM depot 400 mg/ 300 mg, but was not treated and did not have any post-randomization assessments and was not included in safety or efficacy assessments.
|
5.8%
10/172 • Adverse events were monitored from ICF signed untill Follow-up 14 (± 2) days.
One participant was randomly assigned to aripiprazole IM depot 400 mg/ 300 mg, but was not treated and did not have any post-randomization assessments and was not included in safety or efficacy assessments.
|
Additional Information
Global Medical Affairs
Otsuka Pharmaceutical Development and Commercialization, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place