Last reviewed · How we verify
A 38-week, Multicenter, Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Intramuscular Depot Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients With Schizophrenia (ASPIRE)
The purpose of the this trial is to evaluate the efficacy, safety, and tolerability of an intramuscular (IM) depot formulation of aripiprazole as maintenance treatment in patients with schizophrenia The trial is designed into three treatment phases. Phase 1 is designed to allow for a subject to be converted from the current anti-psychotic treatment to oral non-generic aripiprazole monotherapy (oral conversion phase from 4 to 6 weeks). During Phase 2 the subject will be stabilized on oral non-generic aripiprazole monotherapy. Once the subject is stabilized in Phase 2 (oral stabilization phase from minimum 8 weeks to maximum 28 weeks), they are eligible to be randomized into the double-blind IM depot maintenance phase, Phase 3. During Phase 3, the subject will be assessed for exacerbation of psychotic symptoms and impending relapse for up to 38 weeks.
Details
| Lead sponsor | Otsuka Pharmaceutical Development & Commercialization, Inc. |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 937 |
| Start date | 2008-09 |
| Completion | 2012-08 |
Conditions
- Schizophrenia
Interventions
- Aripiprazole depot 300 or 400 mg
- Aripiprazole 10-30 mg orally
- Aripiprazole depot 25 or 50 mg
- Placebo depot
- Placebo tablets
Primary outcomes
- Percentage of Patients Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria by the End of Week 26 — Baseline to Week 26
A patient had exacerbation of psychotic symptoms/impending relapse if they met any of the following 4 criteria. 1) Clinical Global Impression of Improvement score ≥ 5 and either an increase on any of the following Positive and Negative Syndrome Scale (PANSS) items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content) to a score \> 4 with an increase of ≥ 2 on that item since randomization or an increase on any of the same PANSS items to a score \> 4 and an increase of ≥ 4 on the same combined PANSS items since randomization, 2) Hospitalization due to worsening of psychotic symptoms, 3) Clinical Global Impression of Severity of Suicide (CGI-SS) score of 4 or 5 on Part 1 and/or 6 or 7 on Part 2, or 4) Violent behavior resulting in clinically significant self-injury, injury to another person, or property damage.
Countries
United States, Austria, Belgium, Bulgaria, Chile, Croatia, Estonia, France, Hungary, Italy, Poland, Puerto Rico, South Africa, South Korea, Thailand