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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT00705783
First received: June 24, 2008
Last updated: June 16, 2013
Last verified: June 2013
Results First Received: March 29, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Schizophrenia
Interventions: Drug: Aripiprazole depot
Drug: Placebo depot

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
All Patients 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.
Aripiprazole Depot Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
Placebo Depot Patients received placebo intramuscularly every 28 days for 52 weeks.

Participant Flow for 4 periods

Period 1:   Conversion Phase
    All Patients     Aripiprazole Depot     Placebo Depot  
STARTED     633     0 [1]   0 [1]
Received Study Medication     632     0     0  
COMPLETED     500     0     0  
NOT COMPLETED     133     0     0  
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 2:   Oral Stabilization Phase
    All Patients     Aripiprazole Depot     Placebo Depot  
STARTED     710 [1]   0 [2]   0 [2]
Received Study Medication     709     0     0  
COMPLETED     576     0     0  
NOT COMPLETED     134     0     0  
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 3:   Depot Stabilization Phase
    All Patients     Aripiprazole Depot     Placebo Depot  
STARTED     576     0 [1]   0 [1]
COMPLETED     403     0     0  
NOT COMPLETED     173     0     0  
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 4:   Depot Maintenance Phase
    All Patients     Aripiprazole Depot     Placebo Depot  
STARTED     0 [1]   269     134  
COMPLETED     0     23     3  
NOT COMPLETED     0     246     131  
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.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline measures are based on the participants from the Depot Maintenance Phase.

Reporting Groups
  Description
Aripiprazole Depot Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 52 weeks.
Placebo Depot Patients received placebo intramuscularly every 28 days for 52 weeks.
Total Total of all reporting groups

Baseline Measures
    Aripiprazole Depot     Placebo Depot     Total  
Number of Participants  
[units: participants]
  269     134     403  
Age  
[units: years]
Mean ± Standard Deviation
  40.1  ± 11.0     41.7  ± 10.5     40.6  ± 10.8  
Gender  
[units: participants]
     
Female     107     55     162  
Male     162     79     241  



  Outcome Measures
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1.  Primary:   Time to Exacerbation of Psychotic Symptoms/Impending Relapse   [ Time Frame: Baseline of the depot maintenance phase to the end of the study (Week 52) ]

2.  Secondary:   Percentage of Patients Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria   [ Time Frame: Baseline of the depot maintenance phase to the end of the study (Week 52) ]

3.  Secondary:   Percentage of Responders   [ Time Frame: Baseline of the depot maintenance phase to the end of the study (Week 52) ]

4.  Secondary:   Percentage of Patients Achieving Remission   [ Time Frame: Baseline of the depot maintenance phase to the end of the study (Week 52) ]

5.  Secondary:   Mean Change From Baseline in the PANSS Total Score   [ Time Frame: Baseline of the depot maintenance phase to the end of the study (Week 52) ]

6.  Secondary:   Mean Change From Baseline in the Clinical Global Impression - Severity (CGI-S) Score   [ Time Frame: Baseline of the depot maintenance phase to the end of the study (Week 52) ]

7.  Secondary:   Mean Change From Baseline in the PANSS Positive Subscale Score   [ Time Frame: Baseline of the depot maintenance phase to the end of the study (Week 52) ]

8.  Secondary:   Mean Change From Baseline in the PANSS Negative Subscale Score   [ Time Frame: Baseline of the depot maintenance phase to the end of the study (Week 52) ]

9.  Secondary:   Mean Clinical Global Impression-Improvement (CGI-I) Score   [ Time Frame: Baseline of the depot maintenance phase to the end of the study (Week 52) ]

10.  Secondary:   Time to Discontinuation   [ Time Frame: Baseline of the depot maintenance phase to the end of the study (Week 52) ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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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.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Global Medical Affairs
Organization: Otsuka Pharmaceutical Development and Commercialization
phone: 800 562-3974


Publications of Results:
Publications automatically indexed to this study:

Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT00705783     History of Changes
Other Study ID Numbers: 31-07-246
Study First Received: June 24, 2008
Results First Received: March 29, 2013
Last Updated: June 16, 2013
Health Authority: United States: Food and Drug Administration
India: Drugs Controller General of India
Taiwan: Department of Health
Romania: Ministry of Public Health
Slovakia: State Institute for Drug Control
Malaysia: Ministry of Health
Bulgaria: Ministry of Health
Russia: Pharmacological Committee, Ministry of Health
Philippines: Department of Health
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Mexico: Federal Commission for Sanitary Risks Protection