Clinical Trial


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


Brief description

To evaluate the overall effectiveness of aripiprazole intramuscular (IM) depot as maintenance treatment in patients with schizophrenia.

Detailed Description

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.

Keywords

  •   Schizophrenia

Sponsored By

Otsuka Pharmaceutical Development & Commercialization, Inc.

Unique Study ID

NCT00731549

Investigators and Research Sites Near You - Found( 3 )

No Investigator Listed

Bristol-Myers Squibb
85224, Chandler, Arizona, United States
Distance from Current Trial is 0 miles

No Investigator Listed

AbbVie
85224-5665, Chandler, Arizona, United States
Distance from Current Trial is 0 miles

No Investigator Listed

Orasis Pharmaceuticals Ltd.
85225, Chandler, Arizona, United States
Distance from Current Trial is 0 miles
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