Conditions: Schizophrenia
Keywords: Schizophrenia Mental Disorders Antipsychotic Agents Iloperidone Relapse Prevention
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 635
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether Iloperidone is effective in the prevention of relapse in patients with schizophrenia

Detailed description:

Arms:
arm 1: After meeting all entry criteria, completing a 1-week open-label iloperidone titation period (up to 12 mg/day), followed by a 14-24 week open-label iloperidone flexible dose-stabilization period (up to 24 mg/day), approximately 260 patients will be randomized to one of two arms in a 1:1 ratio of iloperidone (flexible dosing 8-24 mg/day) to placebo. Post-randomization double-blind study medication will be administered orally twice daily for up to 26 weeks to evaluate relapse prevention. Subsequently, during the extension period, after a 1-week mock double-blind titration, open-label iloperidone (8-24 mg/day) is administered for up to 51 weeks to evaluate long-term safety. arm 2: Post-randomization matching placebo is administered orally bid during the double-blind period.

Interventions: intervention 1: Iloperidone intervention 2: Placebo
Intervention descriptions: intervention 1: Over-encapsulated iloperidone tablets were administered orally using a bid schedule; the strengths used include 1, 2, 4, 6, 8, 10, and 12 mg. intervention 2: Matching placebo capsules were administered orally using a bid schedule during the double-blind period.

Protocol document: