Schizophrenia Clinical Trial
Official title:
A 52-week, Multicenter, Open-label Study to Evaluate the Effectiveness of Aripiprazole Intramuscular Depot as Maintenance Treatment in Patients With Schizophrenia
To evaluate the overall effectiveness of aripiprazole intramuscular (IM) depot as maintenance treatment in patients with schizophrenia.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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