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Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia (ASPIRE)

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ClinicalTrials.gov Identifier: NCT00705783
Recruitment Status : Completed
First Posted : June 26, 2008
Results First Posted : July 19, 2013
Last Update Posted : July 19, 2013
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Schizophrenia
Interventions Drug: Aripiprazole depot
Drug: Placebo depot
Enrollment 843
Recruitment Details  
Pre-assignment Details There were 4 phases in this study. In phases 1-3 (Conversion Phase, Oral Stabilization Phase, Depot Stabilization Phase), there was a single treatment group. In phase 4 (Depot Maintenance Phase), there were 2 treatment groups. All Outcome Measures were assessed in the Depot Maintenance Phase of the study.
Arm/Group Title All Patients Aripiprazole Depot Placebo Depot
Hide Arm/Group Description During the Conversion Phase, patients were cross-titrated from other antipsychotics to oral non-generic aripiprazole monotherapy. During the Oral Stabilization Phase, patients were stabilized on an oral dose of aripiprazole ranging from 10 mg to 30 mg daily. During the Depot Stabilization Phase, patients were stabilized on aripiprazole depot. Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks. Patients received placebo intramuscularly every 28 days for 52 weeks.
Period Title: Conversion Phase
Started 633 0 [1] 0 [1]
Received Study Medication 632 0 0
Completed 500 0 0
Not Completed 133 0 0
Reason Not Completed
Sponsor Discontinued Study             54             0             0
Lost to Follow-up             13             0             0
Met Withdrawal Criteria             4             0             0
Withdrawn by Investigator             4             0             0
Withdrew Consent             24             0             0
Protocol Deviation             2             0             0
Adverse Event             11             0             0
Lack of Efficacy with Adverse Event             13             0             0
Lack of Efficacy without Adverse Event             8             0             0
[1]
There were no patients in this reporting group in this phase of the study.
Period Title: Oral Stabilization Phase
Started 710 [1] 0 [2] 0 [2]
Received Study Medication 709 0 0
Completed 576 0 0
Not Completed 134 0 0
Reason Not Completed
Sponsor Discontinue Study             42             0             0
Lost to Follow-up             7             0             0
Met Withdrawal Criteria             19             0             0
Withdrawn by Investigator             12             0             0
Withdrew Consent             29             0             0
Adverse Event             14             0             0
Lack of Efficacy with Adverse Event             7             0             0
Lack of Efficacy without Adverse Event             4             0             0
[1]
210 of the 710 patients who started this phase enrolled in this study directly into this phase.
[2]
There were no patients in this reporting group in this phase of the study.
Period Title: Depot Stabilization Phase
Started 576 0 [1] 0 [1]
Completed 403 0 0
Not Completed 173 0 0
Reason Not Completed
Sponsor Discontinued Study             86             0             0
Lost to Follow-up             11             0             0
Met Withdrawal Criteria             8             0             0
Withdrawn by Investigator             9             0             0
Withdrew Consent             29             0             0
Adverse Event             17             0             0
Lack of Efficacy with Adverse Event             12             0             0
Lack of Efficacy without Adverse Event             1             0             0
[1]
There were no patients in this reporting group in this phase of the study.
Period Title: Depot Maintenance Phase
Started 0 [1] 269 134
Completed 0 23 3
Not Completed 0 246 131
Reason Not Completed
Sponsor Discontinued Study             0             179             58
Lost to Follow-up             0             5             3
Met Withdrawal Criteria             0             2             2
Withdrawn by Investigator             0             8             6
Withdrew Consent             0             14             4
Protocol Deviation             0             2             0
Adverse Event without Impending Relapse             0             9             5
Impending Relapse with Adverse Event             0             11             13
Impending Relapse without Adverse Event             0             16             40
[1]
Patients were randomized into the aripiprazole and placebo depot groups in this phase of the study.
Arm/Group Title Aripiprazole Depot Placebo Depot Total
Hide Arm/Group Description Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks. Patients received placebo intramuscularly every 28 days for 52 weeks. Total of all reporting groups
Overall Number of Baseline Participants 269 134 403
Hide Baseline Analysis Population Description
Baseline measures are based on the participants from the Depot Maintenance Phase.
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 269 participants 134 participants 403 participants
40.1  (11.0) 41.7  (10.5) 40.6  (10.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 269 participants 134 participants 403 participants
Female
107
  39.8%
55
  41.0%
162
  40.2%
Male
162
  60.2%
79
  59.0%
241
  59.8%
1.Primary Outcome
Title Time to Exacerbation of Psychotic Symptoms/Impending Relapse
Hide Description A patient experienced an exacerbation of psychotic symptoms/impending relapse if they met any of the following 4 criteria. 1) Clinical Global Impression of Improvement score ≥ 5 and either an increase on any of the following Positive and Negative Syndrome Scale (PANSS) items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content) to a score > 4 with an increase of ≥ 2 on that item since randomization or an increase on any of the same PANSS items to a score > 4 and an increase of ≥ 4 on the same combined PANSS items since randomization, 2) Hospitalization due to worsening of psychotic symptoms, 3) Clinical Global Impression of Severity of Suicide (CGI-SS) score of 4 or 5 on Part 1 and/or 6 or 7 on Part 2, or 4) Violent behavior resulting in clinically significant self-injury, injury to another person, or property damage.
Time Frame Baseline of the depot maintenance phase to the end of the study (Week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized patients.
Arm/Group Title Aripiprazole Depot Placebo Depot
Hide Arm/Group Description:
Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
Patients received placebo intramuscularly every 28 days for 52 weeks.
Overall Number of Participants Analyzed 269 134
Median (95% Confidence Interval)
Unit of Measure: Days
NA [1] 
(NA to NA)
209
(161 to 254)
[1]
The median and confidence interval were not estimable due to too few events.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aripiprazole Depot, Placebo Depot
Comments Based on 6-month IR rates of 55% for placebo and 35% for aripiprazole, sample sizes were estimated to achieve 90% power to detect a hazard ratio of 0.54 and to preserve an overall nominal alpha level of 0.05 (2-sided), allowing for 2 interim looks at 50% and 75% of events. Assuming that each subject was followed for 12 months after randomization and allowing for a 25% loss to follow-up, the projected total number of subjects to be randomly assigned to treatment in the trial was 225.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.199
Confidence Interval (2-Sided) 95%
0.125 to 0.317
Estimation Comments Aripiprazole depot/placebo depot
2.Secondary Outcome
Title Percentage of Patients Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria
Hide Description This is the key secondary Outcome Measure.
Time Frame Baseline of the depot maintenance phase to the end of the study (Week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized patients.
Arm/Group Title Aripiprazole Depot Placebo Depot
Hide Arm/Group Description:
Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
Patients received placebo intramuscularly every 28 days for 52 weeks.
Overall Number of Participants Analyzed 269 134
Measure Type: Number
Unit of Measure: Percentage of patients
10.0 39.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aripiprazole Depot, Placebo Depot
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The alpha levels for this key secondary Outcome Measure were the same as used for the primary Outcome Measure.
Method Chi-squared
Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Responders
Hide Description A patient was considered to be a responder if all of the following criteria were met. 1) Outpatient status, 2) PANSS total score ≤ 80, 3) Lack of specific psychotic symptoms on the PANSS as measured by a score of ≤ 4 on each of the following items (possible scores of 1 to 7 for each item): Conceptual disorganization, suspiciousness, hallucinatory behavior, unusual thought content, and 4) Clinical Global Impression of Severity of Illness (CGI-S) ≤ 4 (moderately ill) and 5) CGI-SS ≤ 2 (mildly suicidal) on Part 1 and ≤ 5 (minimally worsened) on Part 2.
Time Frame Baseline of the depot maintenance phase to the end of the study (Week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: All randomized patients. Two of the 269 patients in the ITT population did not attend the Last Visit at which this Outcome Measure was assessed and were not included in the analysis.
Arm/Group Title Aripiprazole Depot Placebo Depot
Hide Arm/Group Description:
Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
Patients received placebo intramuscularly every 28 days for 52 weeks.
Overall Number of Participants Analyzed 267 134
Measure Type: Number
Unit of Measure: Percentage of patients
87.6 56.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aripiprazole Depot, Placebo Depot
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Patients Achieving Remission
Hide Description A patient was considered to have achieved remission if they had a score of ≤ 3 on each of the following PANSS items, maintained for a period of 6 months: Delusions (P1), unusual thought content (G9), hallucinatory behavior (P3), conceptual disorganization (P2), mannerisms/posturing (G5), blunted affect (N1), social withdrawal (N4), and lack of spontaneity (N6).
Time Frame Baseline of the depot maintenance phase to the end of the study (Week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized patients who stayed in Phase 4 for at least 6 months and had values for the specific PANSS items P1, G9, P3, P2,G5, N1, N4, and N6.
Arm/Group Title Aripiprazole Depot Placebo Depot
Hide Arm/Group Description:
Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
Patients received placebo intramuscularly every 28 days for 52 weeks.
Overall Number of Participants Analyzed 87 31
Measure Type: Number
Unit of Measure: Percentage of patients
52.9 38.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aripiprazole Depot, Placebo Depot
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1756
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
5.Secondary Outcome
Title Mean Change From Baseline in the PANSS Total Score
Hide Description The PANSS consists of 3 subscales (Positive Subscale, 7 constructs, scores ranged from 7-49, Negative Subscale, 7 constructs, scores ranged from 7-49, General Psychopathology Subscale, 16 constructs, scores ranged from 16-112) containing a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. The PANSS total score ranged from 30-210 with a higher score indicating more severe symptoms. A negative change score indicates improvement.
Time Frame Baseline of the depot maintenance phase to the end of the study (Week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized patients who had PANSS total scores at both baseline and at least 1 post-baseline time point in Phase 4. Last observation carried forward was implemented to impute the missing data at post-baseline visits. Baseline was not carried forward in imputing the missing data at post-baseline visits.
Arm/Group Title Aripiprazole Depot Placebo Depot
Hide Arm/Group Description:
Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
Patients received placebo intramuscularly every 28 days for 52 weeks.
Overall Number of Participants Analyzed 25 4
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
1.43  (0.756) 11.55  (1.066)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aripiprazole Depot, Placebo Depot
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments The ANCOVA included treatment as a term and baseline as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -10.11
Confidence Interval (2-Sided) 95%
-12.68 to -7.54
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Mean Change From Baseline in the Clinical Global Impression - Severity (CGI-S) Score
Hide Description The severity of illness for each patient was rated using the CGI-S. 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 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. The CGI-S score ranged from 0-7 with a higher score indicating greater illness. A negative change score indicates improvement.
Time Frame Baseline of the depot maintenance phase to the end of the study (Week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized patients who had CGI-S scores at both baseline and at least 1 post-baseline time point in Phase 4. Last observation carried forward was implemented to impute the missing data at post-baseline visits. Baseline was not carried forward in imputing the missing data at post-baseline visits.
Arm/Group Title Aripiprazole Depot Placebo Depot
Hide Arm/Group Description:
Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
Patients received placebo intramuscularly every 28 days for 52 weeks.
Overall Number of Participants Analyzed 266 134
Mean (Standard Error)
Unit of Measure: Units on a scale
0.14  (0.051) 0.66  (0.073)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aripiprazole Depot, Placebo Depot
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments The ANCOVA included treatment as a term and baseline as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.52
Confidence Interval (2-Sided) 95%
-0.70 to -0.35
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Mean Change From Baseline in the PANSS Positive Subscale Score
Hide Description The PANSS Positive Subscale consists of 7 symptom constructs (delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility). For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. Scores on each subscale ranged from 7-49 with a higher score indicating more severe symptoms. A negative change score indicates improvement.
Time Frame Baseline of the depot maintenance phase to the end of the study (Week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized patients who had PANSS sub-scale scores at both baseline and at least 1 post-baseline time point in Phase 4. Last observation carried forward was implemented to impute the missing data at post-baseline visits. Baseline was not carried forward in imputing the missing data at post-baseline visits.
Arm/Group Title Aripiprazole Depot Placebo Depot
Hide Arm/Group Description:
Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
Patients received placebo intramuscularly every 28 days for 52 weeks.
Overall Number of Participants Analyzed 266 134
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
0.44  (0.265) 4.25  (0.374)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aripiprazole Depot, Placebo Depot
Comments Positive Subscale Score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments The ANCOVA included treatment as a term and baseline as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.82
Confidence Interval (2-Sided) 95%
-4.72 to -2.91
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Mean Change From Baseline in the PANSS Negative Subscale Score
Hide Description The PANSS Negative Subscale consists of 7 symptom constructs (blunted affect, emotional withdrawal, poor rapport, passive pathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking). For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. Scores on each subscale ranged from 7-49 with a higher score indicating more severe symptoms. A negative change score indicates improvement.
Time Frame Baseline of the depot maintenance phase to the end of the study (Week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized patients who had PANSS sub-scale scores at both baseline and at least 1 post-baseline time point in Phase 4. Last observation carried forward was implemented to impute the missing data at post-baseline visits. Baseline was not carried forward in imputing the missing data at post-baseline visits.
Arm/Group Title Aripiprazole Depot Placebo Depot
Hide Arm/Group Description:
Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
Patients received placebo intramuscularly every 28 days for 52 weeks.
Overall Number of Participants Analyzed 266 134
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
0.19  (0.201) 1.55  (0.284)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aripiprazole Depot, Placebo Depot
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method ANCOVA
Comments The ANCOVA included treatment as a term and baseline as a covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.36
Confidence Interval (2-Sided) 95%
-2.04 to -0.67
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Mean Clinical Global Impression-Improvement (CGI-I) Score
Hide Description The efficacy of the study medication was rated for each patient using the CGI-I scale. The rater or investigator rated the patient’s total improvement whether or not it was due entirely to drug treatment. All responses were compared to the patient’s condition at Baseline. 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. The CGI-I score ranged from 0-7 with a higher score indicating less improvement/worsening.
Time Frame Baseline of the depot maintenance phase to the end of the study (Week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized patients who had CGI-I scores at both baseline and at least 1 post-baseline time point in Phase 4. Last observation carried forward was implemented to impute the missing data at post-baseline visits. Baseline was not carried forward in imputing the missing data at post-baseline visits.
Arm/Group Title Aripiprazole Depot Placebo Depot
Hide Arm/Group Description:
Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
Patients received placebo intramuscularly every 28 days for 52 weeks.
Overall Number of Participants Analyzed 266 133
Mean (Standard Deviation)
Unit of Measure: Units on a scale
3.70  (1.05) 4.53  (1.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aripiprazole Depot, Placebo Depot
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
10.Secondary Outcome
Title Time to Discontinuation
Hide Description Time to discontinuation was defined as the date of randomization to the date of study discontinuation.
Time Frame Baseline of the depot maintenance phase to the end of the study (Week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized patients.
Arm/Group Title Aripiprazole Depot Placebo Depot
Hide Arm/Group Description:
Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
Patients received placebo intramuscularly every 28 days for 52 weeks.
Overall Number of Participants Analyzed 269 134
Median (95% Confidence Interval)
Unit of Measure: Days
NA [1] 
(364 to NA)
162
(98 to 211)
[1]
The median and the upper limit of the confidence interval were not estimable due to too few events.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aripiprazole Depot, Placebo Depot
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Time Frame Adverse events were reported from the time of the signing of informed consent until the end of the study (up to 106 weeks).
Adverse Event Reporting Description Safety population: All subjects who received at least 1 dose of study medication.
 
Arm/Group Title Conversion Phase Oral Stabilization Phase Depot Stabilization Phase Aripiprazole Depot - Depot Maintenance Phase Placebo Depot - Depot Maintenance Phase
Hide Arm/Group Description During the Conversion Phase, patients were cross-titrated from other antipsychotics to oral non-generic aripiprazole monotherapy. During the Oral Stabilization Phase, patients were stabilized on an oral dose of aripiprazole ranging from 10 mg to 30 mg daily. During the IM Depot Stabilization Phase, patients were stabilized on aripiprazole IM depot. Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks. Patients received placebo intramuscularly every 28 days for 52 weeks.
All-Cause Mortality
Conversion Phase Oral Stabilization Phase Depot Stabilization Phase Aripiprazole Depot - Depot Maintenance Phase Placebo Depot - Depot Maintenance Phase
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Conversion Phase Oral Stabilization Phase Depot Stabilization Phase Aripiprazole Depot - Depot Maintenance Phase Placebo Depot - Depot Maintenance Phase
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   13/632 (2.06%)   10/709 (1.41%)   25/576 (4.34%)   11/269 (4.09%)   9/134 (6.72%) 
Blood and lymphatic system disorders           
Anaemia  1  0/632 (0.00%)  0/709 (0.00%)  1/576 (0.17%)  0/269 (0.00%)  0/134 (0.00%) 
Cardiac disorders           
Acute myocardial infarction  1  0/632 (0.00%)  0/709 (0.00%)  1/576 (0.17%)  0/269 (0.00%)  0/134 (0.00%) 
Cardiac failure congestive  1  0/632 (0.00%)  0/709 (0.00%)  1/576 (0.17%)  0/269 (0.00%)  0/134 (0.00%) 
Coronary artery insufficiency  1  0/632 (0.00%)  0/709 (0.00%)  1/576 (0.17%)  0/269 (0.00%)  0/134 (0.00%) 
Myocardial ischaemia  1  0/632 (0.00%)  0/709 (0.00%)  1/576 (0.17%)  0/269 (0.00%)  0/134 (0.00%) 
Sinus bradycardia  1  0/632 (0.00%)  0/709 (0.00%)  0/576 (0.00%)  0/269 (0.00%)  1/134 (0.75%) 
Gastrointestinal disorders           
Diarrhoea  1  0/632 (0.00%)  0/709 (0.00%)  0/576 (0.00%)  0/269 (0.00%)  1/134 (0.75%) 
General disorders           
Chest pain  1  0/632 (0.00%)  0/709 (0.00%)  1/576 (0.17%)  0/269 (0.00%)  0/134 (0.00%) 
Hepatobiliary disorders           
Biliary colic  1  0/632 (0.00%)  0/709 (0.00%)  0/576 (0.00%)  0/269 (0.00%)  1/134 (0.75%) 
Infections and infestations           
Cholecystitis infective  1  0/632 (0.00%)  0/709 (0.00%)  1/576 (0.17%)  0/269 (0.00%)  0/134 (0.00%) 
Gastroenteritis  1  0/632 (0.00%)  0/709 (0.00%)  1/576 (0.17%)  0/269 (0.00%)  0/134 (0.00%) 
Lobar pneumonia  1  0/632 (0.00%)  0/709 (0.00%)  1/576 (0.17%)  0/269 (0.00%)  0/134 (0.00%) 
Injury, poisoning and procedural complications           
Rib fracture  1  1/632 (0.16%)  0/709 (0.00%)  0/576 (0.00%)  0/269 (0.00%)  0/134 (0.00%) 
Wrist fracture  1  1/632 (0.16%)  1/709 (0.14%)  0/576 (0.00%)  0/269 (0.00%)  0/134 (0.00%) 
Femur fracture  1  0/632 (0.00%)  0/709 (0.00%)  1/576 (0.17%)  0/269 (0.00%)  0/134 (0.00%) 
Gun shot wound  1  0/632 (0.00%)  0/709 (0.00%)  0/576 (0.00%)  1/269 (0.37%)  0/134 (0.00%) 
Injury  1  0/632 (0.00%)  0/709 (0.00%)  0/576 (0.00%)  1/269 (0.37%)  0/134 (0.00%) 
Multiple injuries  1  0/632 (0.00%)  0/709 (0.00%)  0/576 (0.00%)  1/269 (0.37%)  0/134 (0.00%) 
Investigations           
Blood creatine phosphokinase increased  1  0/632 (0.00%)  0/709 (0.00%)  1/576 (0.17%)  0/269 (0.00%)  0/134 (0.00%) 
Metabolism and nutrition disorders           
Diabetes mellitus  1  0/632 (0.00%)  0/709 (0.00%)  0/576 (0.00%)  1/269 (0.37%)  0/134 (0.00%) 
Hyperglycaemia  1  0/632 (0.00%)  0/709 (0.00%)  0/576 (0.00%)  1/269 (0.37%)  0/134 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Ovarian cancer  1  0/632 (0.00%)  0/709 (0.00%)  1/576 (0.17%)  0/269 (0.00%)  0/134 (0.00%) 
Pancreatic carcinoma  1  0/632 (0.00%)  0/709 (0.00%)  0/576 (0.00%)  1/269 (0.37%)  0/134 (0.00%) 
Nervous system disorders           
Convulsion  1  1/632 (0.16%)  0/709 (0.00%)  0/576 (0.00%)  0/269 (0.00%)  0/134 (0.00%) 
Syncope  1  1/632 (0.16%)  0/709 (0.00%)  0/576 (0.00%)  0/269 (0.00%)  0/134 (0.00%) 
Paraesthesia  1  0/632 (0.00%)  0/709 (0.00%)  1/576 (0.17%)  0/269 (0.00%)  0/134 (0.00%) 
Grand mal convulsion  1  0/632 (0.00%)  0/709 (0.00%)  0/576 (0.00%)  0/269 (0.00%)  1/134 (0.75%) 
Psychiatric disorders           
Psychotic disorder  1  2/632 (0.32%)  1/709 (0.14%)  2/576 (0.35%)  4/269 (1.49%)  4/134 (2.99%) 
Schizophrenia  1  6/632 (0.95%)  6/709 (0.85%)  9/576 (1.56%)  2/269 (0.74%)  2/134 (1.49%) 
Schizophrenia, paranoid type  1  2/632 (0.32%)  1/709 (0.14%)  2/576 (0.35%)  0/269 (0.00%)  0/134 (0.00%) 
Suicidal ideation  1  2/632 (0.32%)  0/709 (0.00%)  0/576 (0.00%)  2/269 (0.74%)  0/134 (0.00%) 
Delusion  1  0/632 (0.00%)  0/709 (0.00%)  1/576 (0.17%)  0/269 (0.00%)  0/134 (0.00%) 
Hallucination  1  0/632 (0.00%)  0/709 (0.00%)  1/576 (0.17%)  0/269 (0.00%)  0/134 (0.00%) 
Paranoia  1  0/632 (0.00%)  0/709 (0.00%)  1/576 (0.17%)  0/269 (0.00%)  0/134 (0.00%) 
Psychiatric symptom  1  0/632 (0.00%)  1/709 (0.14%)  0/576 (0.00%)  0/269 (0.00%)  0/134 (0.00%) 
Schizoaffective disorder  1  0/632 (0.00%)  0/709 (0.00%)  1/576 (0.17%)  0/269 (0.00%)  0/134 (0.00%) 
Hallucination, auditory  1  0/632 (0.00%)  0/709 (0.00%)  0/576 (0.00%)  1/269 (0.37%)  0/134 (0.00%) 
Suicide attempt  1  0/632 (0.00%)  0/709 (0.00%)  0/576 (0.00%)  1/269 (0.37%)  0/134 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Conversion Phase Oral Stabilization Phase Depot Stabilization Phase Aripiprazole Depot - Depot Maintenance Phase Placebo Depot - Depot Maintenance Phase
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   113/632 (17.88%)   50/709 (7.05%)   184/576 (31.94%)   103/269 (38.29%)   43/134 (32.09%) 
General disorders           
Injection site pain  1  0/632 (0.00%)  2/709 (0.28%)  34/576 (5.90%)  8/269 (2.97%)  5/134 (3.73%) 
Infections and infestations           
Nasopharyngitis  1  14/632 (2.22%)  6/709 (0.85%)  11/576 (1.91%)  10/269 (3.72%)  7/134 (5.22%) 
Investigations           
Weight increased  1  8/632 (1.27%)  16/709 (2.26%)  40/576 (6.94%)  26/269 (9.67%)  13/134 (9.70%) 
Nervous system disorders           
Headache  1  45/632 (7.12%)  23/709 (3.24%)  34/576 (5.90%)  16/269 (5.95%)  7/134 (5.22%) 
Akathisia  1  30/632 (4.75%)  33/709 (4.65%)  36/576 (6.25%)  15/269 (5.58%)  8/134 (5.97%) 
Tremor  1  16/632 (2.53%)  14/709 (1.97%)  21/576 (3.65%)  16/269 (5.95%)  2/134 (1.49%) 
Psychiatric disorders           
Insomnia  1  76/632 (12.03%)  50/709 (7.05%)  46/576 (7.99%)  27/269 (10.04%)  12/134 (8.96%) 
Anxiety  1  27/632 (4.27%)  29/709 (4.09%)  38/576 (6.60%)  16/269 (5.95%)  10/134 (7.46%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Medical Affairs
Organization: Otsuka Pharmaceutical Development and Commercialization
Phone: 800 562-3974
Layout table for additonal information
Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT00705783     History of Changes
Other Study ID Numbers: 31-07-246
First Submitted: June 24, 2008
First Posted: June 26, 2008
Results First Submitted: March 29, 2013
Results First Posted: July 19, 2013
Last Update Posted: July 19, 2013