Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia (ASPIRE)
To evaluate the overall effectiveness of aripiprazole intramuscular (IM) depot as maintenance treatment in patients with schizophrenia.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A 52-week, Multicenter, Open-label Study to Evaluate the Effectiveness of Aripiprazole Intramuscular Depot as Maintenance Treatment in Patients With Schizophrenia|
- The percentage of stable subjects at baseline who remain stable at endpoint. [ Time Frame: Weekly visits for first 4 weeks, then bi-weekly until Week 12, then visits every 4 weeks ] [ Designated as safety issue: No ]
- Proportion of subjects meeting exacerbation of psychotic symptoms/impending relapse criteria. [ Time Frame: Bi-weekly for 12 weeks and every 4 weeks for 40 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||December 2008|
|Estimated Study Completion Date:||January 2014|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Active Treatment of aripiprazole IM depot (300mg or 400mg)
Drug: Aripiprazole IM Depot
300mg or 400mg
Other Name: Oral Aripiprazole
This will be an open-label, uncontrolled study which will enroll subjects from Phase 4 of Study 31-07-246 and Phase 3 of Study 31- 07-247 and new subjects not participating in Studies 246/247. The treatment history of subjects prior to enrollment in the open-label study will vary according to the design of the pivotal double-blind study (i.e., 31-07-246 or 31-07-247).
This open-label study will be comprised of phases similar to the pivotal double-blind studies (i.e., Studies 246/247): a screening phase (if applicable), a conversion phase (Phase 1, if applicable), an oral stabilization phase (Phase 2), and an IM depot open-label maintenance phase (Phase 3). Phase 3 will be a 52-week treatment period with a 26-week follow-up period.
During Phase 3 (the open-label maintenance phase) oral aripiprazole rescue medication will be allowed for subjects who do not meet stability criteria or meet the criteria for impending relapse/exacerbation of psychotic symptoms.
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