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Trial record 94 of 408 for:    ARIPIPRAZOLE

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

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ClinicalTrials.gov Identifier: NCT00706654
Recruitment Status : Completed
First Posted : June 27, 2008
Results First Posted : August 14, 2013
Last Update Posted : August 14, 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 300 or 400 mg
Drug: Aripiprazole 10-30 mg orally
Drug: Aripiprazole depot 25 or 50 mg
Drug: Placebo depot
Drug: Placebo tablets
Enrollment 937
Recruitment Details  
Pre-assignment Details There were 3 phases in this study. In phases 1 and 2 (Conversion Phase and Oral Stabilization Phase), there was 1 reporting group. In phase 3 (Depot Maintenance Phase), there were 3 reporting groups. All Outcome Measures were assessed in the Depot Maintenance Phase of the study.
Arm/Group Title All Patients Aripiprazole Depot 300 or 400 mg Aripiprazole 10-30 mg Orally Aripiprazole Depot 25 or 50 mg
Hide Arm/Group Description During the Conversion Phase, patients were cross-titrated from other antipsychotics to oral non-generic aripiprazole monotherapy and during the Oral Stabilization Phase, patients were stabilized on an oral dose of aripiprazole ranging from 10 mg to 30 mg daily. Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks. Patients received aripiprazole 10-30 mg orally daily for 38 weeks. Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
Period Title: Conversion Phase
Started 709 0 [1] 0 [1] 0 [1]
Completed 614 0 0 0
Not Completed 95 0 0 0
Reason Not Completed
Lost to Follow-up             4             0             0             0
Sponsor Discontinued Trial             8             0             0             0
Met Withdrawal Criteria             2             0             0             0
Withdrawn by Investigator             14             0             0             0
Withdrew Consent             38             0             0             0
Adverse Event             18             0             0             0
Lack of Efficacy with Adverse Event             9             0             0             0
Lack of Efficacy without Adverse Event             2             0             0             0
[1]
There were no patients in this reporting group in this phase of the study.
Period Title: Oral Stabilization Phase
Started 842 [1] 0 [2] 0 [2] 0 [2]
Completed 662 0 0 0
Not Completed 180 0 0 0
Reason Not Completed
Lost to Follow-up             17             0             0             0
Sponsor Discontinue Trial             19             0             0             0
Met Withdrawal Criteria             15             0             0             0
Withdrawn by Investigator             21             0             0             0
Withdrew consent             55             0             0             0
Protocol Deviation             2             0             0             0
Adverse Event             21             0             0             0
Lack of Efficacy with Adverse Event             20             0             0             0
Lack of Efficacy without Adverse Event             10             0             0             0
[1]
228 of the 842 patients who started this phase enrolled directly into this phase of the study.
[2]
There were no patients in this reporting group in this phase of the study.
Period Title: Depot Maintenance Phase
Started 0 [1] 265 266 131
Completed 0 196 178 61
Not Completed 0 69 88 70
Reason Not Completed
Lost to Follow-up             0             4             10             6
Met Withdrawal Criteria             0             4             6             5
Withdrawn by Investigator             0             8             12             8
Withdrew Consent             0             21             29             14
Protocol Deviation             0             2             3             1
Adverse Event without Impending Relapse             0             8             7             7
Impending Relapse with Adverse Event             0             13             12             17
Impending Relapse without Adverse Event             0             9             9             12
[1]
Patients were randomized into the 3 aripiprazole treatment groups in this phase of the study.
Arm/Group Title Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase Aripiprazole 10-30 mg Orally - Depot Maintenance Phase Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase Total
Hide Arm/Group Description Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks. Patients received aripiprazole 10-30 mg orally daily for 38 weeks. Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks. Total of all reporting groups
Overall Number of Baseline Participants 265 266 131 662
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 265 participants 266 participants 131 participants 662 participants
41.7  (10.4) 41.2  (10.8) 40.2  (9.6) 40.7  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 265 participants 266 participants 131 participants 662 participants
Female
105
  39.6%
98
  36.8%
53
  40.5%
256
  38.7%
Male
160
  60.4%
168
  63.2%
78
  59.5%
406
  61.3%
1.Primary Outcome
Title Percentage of Patients Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria by the End of Week 26
Hide Description A patient had 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 to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized patients.
Arm/Group Title Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase Aripiprazole 10-30 mg Orally - Depot Maintenance Phase Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase
Hide Arm/Group Description:
Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.
Patients received aripiprazole 10-30 mg orally daily for 38 weeks.
Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
Overall Number of Participants Analyzed 265 266 131
Measure Type: Number
Unit of Measure: Percentage of patients
7.12 7.76 21.80
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase, Aripiprazole 10-30 mg Orally - Depot Maintenance Phase
Comments Sample sizes were estimated to achieve 93% power for the primary non-inferiority 2-sided comparison at 0.05 significance using large sample normal approximations for the distribution of the difference in binomial proportions. The assumed proportion of impending relapse at or before Week 26 for the oral aripiprazole 10-30 mg arm was 18% and the predefined non-inferiority margin was 11.5%. The sample size was projected to be 260 each for the IM depot 300 or 400 mg and oral 10-30 mg arms.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The test of non-inferiority of was performed using a 95% confidence interval (CI, 2-sided) for the difference in the estimated percentage of patients meeting exacerbation of psychotic symptoms/impending relapse criteria by the end of Week 26. Non-inferiority was considered confirmed if the upper bound of the 2-sided 95% CI was below the predefined margin, 11.5%.
Statistical Test of Hypothesis P-Value 0.7871
Comments [Not Specified]
Method z-statistics
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.64
Confidence Interval (2-Sided) 95%
-5.26 to 3.99
Estimation Comments The 95% CI of the difference in proportions of subjects with impending relapse events between aripiprazole IM depot 300 or 400 mg mg and oral aripiprazole were provided using the pooled SE with assumption of normality of the estimated difference.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase, Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase
Comments For the superiority comparison (assay sensitivity analysis) of IM depot 300 or 400 mg to IM depot 25 or 50 mg, on a 2:1 randomization, sample sizes of 260 and 130, respectively, were calculated to provide about 95% power at the 0.05 significance level (2-sided). A superiority margin of 17% was assumed.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments Once non-inferiority was declared, superiority of depot 300/400 mg over depot 25/50 mg was tested by the difference between the proportion of subjects experiencing impending relapse by the end of Week 26 (2-sided 0.05 significance level z-statistic).
Method z-statistics
Comments The same method was used to compare IM depot 300 or 400 mg with IM depot 25 or 50 mg in the estimated proportion of subjects with impending relapse.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -14.68
Confidence Interval (2-Sided) 95%
-23.09 to -6.27
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Time to Exacerbation of Psychotic Symptoms/Impending Relapse
Hide Description [Not Specified]
Time Frame Baseline to the end of the study (Week 38)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized patients.
Arm/Group Title Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase Aripiprazole 10-30 mg Orally - Depot Maintenance Phase Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase
Hide Arm/Group Description:
Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.
Patients received aripiprazole 10-30 mg orally daily for 38 weeks.
Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
Overall Number of Participants Analyzed 265 266 131
Median (95% Confidence Interval)
Unit of Measure: Days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Due to the low (< 50%) percentage of relapses, median time to exacerbation could not be estimated.
3.Secondary Outcome
Title Percentage of Responders up to Week 38
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 to the end of the study (Week 38)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized patients.
Arm/Group Title Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase Aripiprazole 10-30 mg Orally - Depot Maintenance Phase Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase
Hide Arm/Group Description:
Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.
Patients received aripiprazole 10-30 mg orally daily for 38 weeks.
Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
Overall Number of Participants Analyzed 264 263 129
Measure Type: Number
Unit of Measure: Percentage of patients
89.8 89.4 75.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase, Aripiprazole 10-30 mg Orally - Depot Maintenance Phase
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8750
Comments [Not Specified]
Method z-statistics
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase, Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase
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 z-statistics
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 to the end of the study (Week 38)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population: All randomized patients.
Arm/Group Title Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase Aripiprazole 10-30 mg Orally - Depot Maintenance Phase Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase
Hide Arm/Group Description:
Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.
Patients received aripiprazole 10-30 mg orally daily for 38 weeks.
Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
Overall Number of Participants Analyzed 215 201 72
Measure Type: Number
Unit of Measure: Percentage of patients
48.8 53.2 59.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase, Aripiprazole 10-30 mg Orally - Depot Maintenance Phase
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3700
Comments [Not Specified]
Method z-statistics
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase, Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1097
Comments [Not Specified]
Method z-statistics
Comments [Not Specified]
Time Frame Adverse events were reported from the time of the signing of informed consent until the end of the study.
Adverse Event Reporting Description Safety population: All randomized subjects who received at least 1 dose of study medication.
 
Arm/Group Title All Patients - Conversion Phase All Patients - Oral Stabilization Phase Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase Aripiprazole 10-30 mg Orally - Depot Maintenance Phase Aripiprazole Depot 25 or 50 mg - 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. Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks. Patients received aripiprazole 10-30 mg orally daily for 38 weeks. Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
All-Cause Mortality
All Patients - Conversion Phase All Patients - Oral Stabilization Phase Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase Aripiprazole 10-30 mg Orally - Depot Maintenance Phase Aripiprazole Depot 25 or 50 mg - 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
All Patients - Conversion Phase All Patients - Oral Stabilization Phase Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase Aripiprazole 10-30 mg Orally - Depot Maintenance Phase Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   21/709 (2.96%)   39/842 (4.63%)   15/265 (5.66%)   15/266 (5.64%)   11/131 (8.40%) 
Cardiac disorders           
Sick sinus syndrome  1  0/709 (0.00%)  1/842 (0.12%)  0/265 (0.00%)  0/266 (0.00%)  0/131 (0.00%) 
Acute myocardial infarction  1  0/709 (0.00%)  0/842 (0.00%)  1/265 (0.38%)  1/266 (0.38%)  0/131 (0.00%) 
Cardiac arrest  1  0/709 (0.00%)  0/842 (0.00%)  0/265 (0.00%)  1/266 (0.38%)  0/131 (0.00%) 
Cardiac failure congestive  1  0/709 (0.00%)  0/842 (0.00%)  1/265 (0.38%)  0/266 (0.00%)  0/131 (0.00%) 
Gastrointestinal disorders           
Abdominal hernia  1  1/709 (0.14%)  0/842 (0.00%)  0/265 (0.00%)  0/266 (0.00%)  0/131 (0.00%) 
General disorders           
Chest pain  1  0/709 (0.00%)  0/842 (0.00%)  0/265 (0.00%)  1/266 (0.38%)  0/131 (0.00%) 
Fatigue  1  0/709 (0.00%)  0/842 (0.00%)  0/265 (0.00%)  1/266 (0.38%)  0/131 (0.00%) 
Hernia  1  1/709 (0.14%)  0/842 (0.00%)  0/265 (0.00%)  0/266 (0.00%)  0/131 (0.00%) 
Hepatobiliary disorders           
Cholecystitis chronic  1  0/709 (0.00%)  0/842 (0.00%)  1/265 (0.38%)  0/266 (0.00%)  0/131 (0.00%) 
Infections and infestations           
Appendicitis perforated  1  0/709 (0.00%)  0/842 (0.00%)  1/265 (0.38%)  0/266 (0.00%)  0/131 (0.00%) 
Pneumonia  1  0/709 (0.00%)  0/842 (0.00%)  1/265 (0.38%)  1/266 (0.38%)  0/131 (0.00%) 
Sepsis  1  0/709 (0.00%)  0/842 (0.00%)  0/265 (0.00%)  0/266 (0.00%)  1/131 (0.76%) 
Bronchitis  1  1/709 (0.14%)  0/842 (0.00%)  0/265 (0.00%)  0/266 (0.00%)  0/131 (0.00%) 
Injury, poisoning and procedural complications           
Accidental overdose  1  0/709 (0.00%)  1/842 (0.12%)  0/265 (0.00%)  0/266 (0.00%)  0/131 (0.00%) 
Alcohol poisoning  1  0/709 (0.00%)  2/842 (0.24%)  0/265 (0.00%)  0/266 (0.00%)  0/131 (0.00%) 
Ankle fracture  1  0/709 (0.00%)  1/842 (0.12%)  0/265 (0.00%)  1/266 (0.38%)  0/131 (0.00%) 
Drug toxicity  1  0/709 (0.00%)  1/842 (0.12%)  0/265 (0.00%)  0/266 (0.00%)  0/131 (0.00%) 
Head injury  1  0/709 (0.00%)  1/842 (0.12%)  0/265 (0.00%)  0/266 (0.00%)  0/131 (0.00%) 
Procedural pain  1  0/709 (0.00%)  1/842 (0.12%)  0/265 (0.00%)  0/266 (0.00%)  0/131 (0.00%) 
Radius fracture  1  0/709 (0.00%)  0/842 (0.00%)  1/265 (0.38%)  0/266 (0.00%)  0/131 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Ovarian epithelial cancer  1  0/709 (0.00%)  0/842 (0.00%)  0/265 (0.00%)  1/266 (0.38%)  0/131 (0.00%) 
Ovarian fibroma  1  0/709 (0.00%)  0/842 (0.00%)  0/265 (0.00%)  1/266 (0.38%)  0/131 (0.00%) 
Nervous system disorders           
Convulsion  1  0/709 (0.00%)  0/842 (0.00%)  0/265 (0.00%)  0/266 (0.00%)  1/131 (0.76%) 
Neuroleptic malignant syndrome  1  0/709 (0.00%)  0/842 (0.00%)  0/265 (0.00%)  0/266 (0.00%)  1/131 (0.76%) 
Transient ischemic attack  1  1/709 (0.14%)  0/842 (0.00%)  0/265 (0.00%)  0/266 (0.00%)  0/131 (0.00%) 
Psychiatric disorders           
Aggression  1  0/709 (0.00%)  1/842 (0.12%)  0/265 (0.00%)  0/266 (0.00%)  0/131 (0.00%) 
Agitation  1  0/709 (0.00%)  1/842 (0.12%)  1/265 (0.38%)  0/266 (0.00%)  0/131 (0.00%) 
Anxiety  1  1/709 (0.14%)  1/842 (0.12%)  0/265 (0.00%)  0/266 (0.00%)  0/131 (0.00%) 
Hallucination, auditory  1  0/709 (0.00%)  1/842 (0.12%)  0/265 (0.00%)  0/266 (0.00%)  0/131 (0.00%) 
Insomnia  1  0/709 (0.00%)  1/842 (0.12%)  0/265 (0.00%)  0/266 (0.00%)  0/131 (0.00%) 
Psychotic disorder  1  8/709 (1.13%)  15/842 (1.78%)  4/265 (1.51%)  2/266 (0.75%)  4/131 (3.05%) 
Schizoaffective disorder  1  0/709 (0.00%)  1/842 (0.12%)  0/265 (0.00%)  0/266 (0.00%)  0/131 (0.00%) 
Schizophrenia  1  3/709 (0.42%)  9/842 (1.07%)  5/265 (1.89%)  2/266 (0.75%)  3/131 (2.29%) 
Schizophrenia, paranoid type  1  0/709 (0.00%)  1/842 (0.12%)  0/265 (0.00%)  2/266 (0.75%)  0/131 (0.00%) 
Suicidal ideation  1  2/709 (0.28%)  4/842 (0.48%)  1/265 (0.38%)  0/266 (0.00%)  1/131 (0.76%) 
Completed suicide  1  0/709 (0.00%)  0/842 (0.00%)  0/265 (0.00%)  0/266 (0.00%)  1/131 (0.76%) 
Drug abuse  1  1/709 (0.14%)  0/842 (0.00%)  0/265 (0.00%)  1/266 (0.38%)  0/131 (0.00%) 
Suicide attempt  1  2/709 (0.28%)  0/842 (0.00%)  1/265 (0.38%)  1/266 (0.38%)  0/131 (0.00%) 
Psychotic behaviour  1  1/709 (0.14%)  0/842 (0.00%)  0/265 (0.00%)  0/266 (0.00%)  0/131 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Acute respiratory distress syndrome  1  0/709 (0.00%)  0/842 (0.00%)  1/265 (0.38%)  0/266 (0.00%)  0/131 (0.00%) 
Asthma  1  0/709 (0.00%)  0/842 (0.00%)  0/265 (0.00%)  1/266 (0.38%)  0/131 (0.00%) 
Organising pneumonia  1  0/709 (0.00%)  0/842 (0.00%)  0/265 (0.00%)  0/266 (0.00%)  1/131 (0.76%) 
Aspiration pneumonia  1  1/709 (0.14%)  0/842 (0.00%)  0/265 (0.00%)  0/266 (0.00%)  0/131 (0.00%) 
Chronic obstructive pulmonary disease  1  1/709 (0.14%)  0/842 (0.00%)  0/265 (0.00%)  0/266 (0.00%)  0/131 (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%
All Patients - Conversion Phase All Patients - Oral Stabilization Phase Aripiprazole Depot 300 or 400 mg - Depot Maintenance Phase Aripiprazole 10-30 mg Orally - Depot Maintenance Phase Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   140/709 (19.75%)   177/842 (21.02%)   161/265 (60.75%)   142/266 (53.38%)   74/131 (56.49%) 
General disorders           
Injection site pain  1  0/709 (0.00%)  1/842 (0.12%)  20/265 (7.55%)  6/266 (2.26%)  1/131 (0.76%) 
Infections and infestations           
Influenza  1  9/709 (1.27%)  10/842 (1.19%)  11/265 (4.15%)  11/266 (4.14%)  7/131 (5.34%) 
Nasopharyngitis  1  17/709 (2.40%)  18/842 (2.14%)  21/265 (7.92%)  25/266 (9.40%)  9/131 (6.87%) 
Upper respiratory tract infection  1  14/709 (1.97%)  12/842 (1.43%)  18/265 (6.79%)  11/266 (4.14%)  5/131 (3.82%) 
Investigations           
Weight decreased  1  10/709 (1.41%)  25/842 (2.97%)  26/265 (9.81%)  16/266 (6.02%)  12/131 (9.16%) 
Weight increased  1  5/709 (0.71%)  23/842 (2.73%)  24/265 (9.06%)  35/266 (13.16%)  7/131 (5.34%) 
Musculoskeletal and connective tissue disorders           
Back pain  1  1/709 (0.14%)  14/842 (1.66%)  10/265 (3.77%)  14/266 (5.26%)  15/131 (11.45%) 
Nervous system disorders           
Akathisia  1  36/709 (5.08%)  63/842 (7.48%)  28/265 (10.57%)  18/266 (6.77%)  11/131 (8.40%) 
Headache  1  39/709 (5.50%)  44/842 (5.23%)  26/265 (9.81%)  30/266 (11.28%)  7/131 (5.34%) 
Psychiatric disorders           
Anxiety  1  28/709 (3.95%)  35/842 (4.16%)  19/265 (7.17%)  13/266 (4.89%)  10/131 (7.63%) 
Schizophrenia  1  5/709 (0.71%)  7/842 (0.83%)  3/265 (1.13%)  3/266 (1.13%)  8/131 (6.11%) 
Insomnia  1  78/709 (11.00%)  87/842 (10.33%)  31/265 (11.70%)  37/266 (13.91%)  18/131 (13.74%) 
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: NCT00706654     History of Changes
Other Study ID Numbers: 31-07-247
First Submitted: June 25, 2008
First Posted: June 27, 2008
Results First Submitted: March 29, 2013
Results First Posted: August 14, 2013
Last Update Posted: August 14, 2013