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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;   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

  Participant Flow
  Hide Participant Flow

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
  Hide Baseline Characteristics

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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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
No text entered.


  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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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