Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      This was a randomized, double-blind, placebo-controlled study consisting of a screening phase
      and 4 treatment phases. Eligibility was determined during a screening phase of 2 to 42 days.
      Patients receiving oral treatment with an antipsychotic other than non-generic aripiprazole
      entered Phase 1. Patients with a lapse in aripiprazole or other antipsychotic treatment at
      the time of study entry ("lapse" defined as > 3 consecutive days without medication) entered
      directly into Phase 2. During Phase 1 (oral conversion), patients were cross-titrated during
      weekly visits from other antipsychotics to oral non-generic aripiprazole monotherapy over a
      minimum of 4 weeks and a maximum of 6 weeks. During Phase 2 (a minimum of 4 weeks and a
      maximum of 12 weeks in duration), patients were assessed bi-weekly and stabilized on an oral
      dose of aripiprazole ranging from 10 mg to 30 mg daily. After stability criteria were met in
      Phase 2, patients entered the single-blind aripiprazole intramuscular (IM) depot
      stabilization phase, Phase 3. In Phase 3, patients were stabilized on aripiprazole IM depot
      for 12 consecutive weeks. Once the patient met the stability criteria, they were eligible to
      be randomized into the double-blind phase, Phase 4. Patients were randomized in a 2:1 ratio
      (aripiprazole IM depot vs placebo IM depot) stratified by region and last aripiprazole IM
      depot injection dose level in Phase 3. During Phase 4, patients were assessed for impending
      relapse/exacerbation of psychotic symptoms. If a patient was identified with impending
      relapse/exacerbation of psychotic symptoms, they were withdrawn from the trial and given the
      opportunity to enroll into an open-label aripiprazole IM depot trial, 31-08-248. Patients
      that completed Phase 4 (up to and including Week 52) had the option to enroll into an
      open-label aripiprazole IM depot trial, 31-08-248 (NCT00731549).
    

Intervention name(s): Aripiprazole depot; Placebo depot
Intervention type(s): Drug; Drug
Intervention description(s): Aripiprazole depot was supplied in 400 mg lyophilized vials. Patients received aripiprazole 300 mg if they were unable to tolerate aripiprazole 400 mg.; Placebo depot was supplied in 400 mg lyophilized vials.
Other intervention name(s): Abilify
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Aripiprazole; Intramuscular (IM) depot; Schizophrenia