Conditions: Schizophrenia
Keywords: Aripiprazole IM Depot Schizophrenia Intramuscular
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 1081
Healthy volunteers: no

Brief summary:
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.

Arms:
arm 1: Active Treatment of aripiprazole IM depot (300mg or 400mg)

Interventions: intervention 1: Aripiprazole IM Depot
Intervention descriptions: intervention 1: 300mg or 400mg

Protocol document: