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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:
NCT00706654
First received: June 25, 2008
Last updated: July 12, 2013
Last verified: July 2013
Results First Received: March 29, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, 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

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
All Patients 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.
Aripiprazole Depot 300 or 400 mg Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.
Aripiprazole 10-30 mg Orally Patients received aripiprazole 10-30 mg orally daily for 38 weeks.
Aripiprazole Depot 25 or 50 mg Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.

Participant Flow for 3 periods

Period 1:   Conversion Phase
    All Patients     Aripiprazole Depot 300 or 400 mg     Aripiprazole 10-30 mg Orally     Aripiprazole Depot 25 or 50 mg  
STARTED     709     0 [1]   0 [1]   0 [1]
COMPLETED     614     0     0     0  
NOT COMPLETED     95     0     0     0  
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 2:   Oral Stabilization Phase
    All Patients     Aripiprazole Depot 300 or 400 mg     Aripiprazole 10-30 mg Orally     Aripiprazole Depot 25 or 50 mg  
STARTED     842 [1]   0 [2]   0 [2]   0 [2]
COMPLETED     662     0     0     0  
NOT COMPLETED     180     0     0     0  
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 3:   Depot Maintenance Phase
    All Patients     Aripiprazole Depot 300 or 400 mg     Aripiprazole 10-30 mg Orally     Aripiprazole Depot 25 or 50 mg  
STARTED     0 [1]   265     266     131  
COMPLETED     0     196     178     61  
NOT COMPLETED     0     69     88     70  
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.



  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 300 or 400 mg - Depot Maintenance Phase Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.
Aripiprazole 10-30 mg Orally - Depot Maintenance Phase Patients received aripiprazole 10-30 mg orally daily for 38 weeks.
Aripiprazole Depot 25 or 50 mg - Depot Maintenance Phase Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
Total Total of all reporting groups

Baseline Measures
    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  
Number of Participants  
[units: participants]
  265     266     131     662  
Age  
[units: years]
Mean ± Standard Deviation
  41.7  ± 10.4     41.2  ± 10.8     40.2  ± 9.6     40.7  ± 10.4  
Gender  
[units: Participants]
       
Female     105     98     53     256  
Male     160     168     78     406  



  Outcome Measures
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1.  Primary:   Percentage of Patients Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria by the End of Week 26   [ Time Frame: Baseline to Week 26 ]

2.  Secondary:   Time to Exacerbation of Psychotic Symptoms/Impending Relapse   [ Time Frame: Baseline to the end of the study (Week 38) ]

3.  Secondary:   Percentage of Responders up to Week 38   [ Time Frame: Baseline to the end of the study (Week 38) ]

4.  Secondary:   Percentage of Patients Achieving Remission   [ Time Frame: Baseline to the end of the study (Week 38) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  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.


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


No publications provided by Otsuka Pharmaceutical Development & Commercialization, Inc.

Publications automatically indexed to this study:

Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT00706654     History of Changes
Other Study ID Numbers: 31-07-247
Study First Received: June 25, 2008
Results First Received: March 29, 2013
Last Updated: July 12, 2013
Health Authority: United States: Food and Drug Administration
Austria: Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicinal Products and Health Products
Bulgaria: Ministry of Health
Chile: Instituto de Salud Pública de Chile
Croatia: Ministry of Health and Social Care
Estonia: The State Agency of Medicine
France: Ministry of Health
Hungary: National Institute of Pharmacy
Italy: Ministry of Health
Poland: Ministry of Health
South Africa: Medicines Control Council
South Korea: Korea Food and Drug Administration (KFDA)
Thailand: Food and Drug Administration