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

• The primary efficacy endpoint of this study is time to exacerbation of psychotic symptoms/impending relapse, in schizophrenic patients who have maintained stability on aripiprazole IM depot for at least 12 weeks. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  

• Mean change from baseline to endpoint in PANSS Total Score [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  
• Percentage of subjects meeting exacerbation of psychotic symptoms/impending relapse criteria [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  
• Mean change from baseline to endpoint in CGI-S [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  
• AEs will be examined by frequency, severity, seriousness, and discontinuation from study due to AEs. [ Time Frame: 138 weeks ] [ Designated as safety issue: Yes ]
  
• Suicidality will be summarized by change from baseline in CGI-SS (Part 1) and mean CGI-SS score (Part 2) [ Time Frame: 12 weeks, 36 weeks and 52 weeks ] [ Designated as safety issue: Yes ]
  
• Injection site pain will be evaluated by mean VAS scores as reported by the subject before and after each injection and at each study visit. [ Time Frame: 36 weeks, and 52 weeks ] [ Designated as safety issue: Yes ]
  
• The incidence of clinically significant changes will be calculated for vital signs and routine laboratory tests. [ Time Frame: 106 weeks ] [ Designated as safety issue: Yes ]
  
• The investigator rating of localized pain, redness, swelling, and induration at the injection site will also be tabulated for pre- and post-injection site evaluations at each visit [ Time Frame: 36 weeks and 52 weeks ] [ Designated as safety issue: Yes ]
  
• Mean change from baseline and incidence of clinically significant changes will be calculated for ECG parameters, prolactin concentrations, and body weight. [ Time Frame: 106 weeks ] [ Designated as safety issue: Yes ]
  
• EPS will be evaluated by calculating mean change from baselines in SAS, AIMS, and BARS. [ Time Frame: 106 weeks ] [ Designated as safety issue: Yes ]
  

This will be a randomized, double-blind, placebo-controlled study consisting of a screening phase and four treatment phases. Eligibility will be determined during a screening phase of 2 to 42 days. Subjects currently receiving oral treatment with an antipsychotic other than non-generic aripiprazole will enter Phase 1. Subjects with a lapse in aripiprazole or other antipsychotic treatment at the time of study entry ("lapse" defined as > 3 consecutive days without medication) will enter directly into Phase 2. During Phase 1 (oral conversion), subjects will be 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 (that will be a minimum of 4 weeks and a maximum of 12 weeks in duration), subjects will be assessed bi-weekly and stabilized on an oral dose of aripiprazole ranging from 10 mg to 30 mg daily. After stability criteria are met at Phase 2, subjects will enter the single-blind aripiprazole IM depot stabilization phase, Phase 3. At Phase 3 subjects will need to be stabilized on aripiprazole IM depot for 6 consecutive visits. Once the subjects meet the stability criteria, they are eligible to be randomized into the double-blind phase, Phase 4. Subjects will be randomized with a 2:1 ratio (aripiprazole IM depot vs placebo IM depot). During Phase 4, subjects will be assessed for impending relapse/exacerbation of psychotic symptoms. If a subject is identified with impending relapse/exacerbation of psychotic symptoms, they will be withdrawn from the trial and given the opportunity to enroll into an open-label aripiprazole IM depot trial, 31-08-248. Alternatively, subjects that complete Phase 4 (up to and including week-52) will have the option to enroll into an open-label aripiprazole IM depot trial, 31-08-248.