Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia
Status:
Completed
Trial end date:
2011-02-01
Target enrollment:
Participant gender:
Summary
The purpose of the trial was to evaluate the efficacy, safety, and tolerability of an
intramuscular depot formulation of aripiprazole as maintenance treatment in patients with
schizophrenia.
The trial was designed into 4 treatment phases. Phase 1 was designed to allow for a patient
to be converted from their current antipsychotic treatment to oral non-generic aripiprazole
monotherapy (oral conversion phase from 4 to 6 weeks). During Phase 2, the patient was
stabilized on oral non-generic aripiprazole monotherapy (oral stabilization phase from a
minimum of 4 weeks to a maximum of 12 weeks). Once the patient was stabilized in Phase 2,
they entered Phase 3, the single-blind intramuscular (IM) depot aripiprazole stabilization
phase. The goal of the phase was to stabilize the patient on the IM depot aripiprazole
formulation for a minimum of 12 weeks to a maximum of 36 weeks. When the patient was
stabilized, they were eligible to be randomized into the double-blind IM depot maintenance
phase (Phase 4). During Phase 4, the patient was assessed for exacerbation of psychotic
symptoms and/or impending relapse for up to 52 weeks.
Phase:
Phase 3
Details
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.