Conditions: Schizophrenia
Keywords: Schizophrenia long-acting injectable antipsychotic medication
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1221
Healthy volunteers: no

Brief summary:
The purpose of this study is to demonstrate the effectiveness of paliperidone palmitate in patients with Schizophrenia.

Detailed description:
This is a randomized (patients assigned to treatment groups by chance), double-blind (patient and study staff will not know the treatment assignment) study of paliperidone palmitate compared with RISPERDAL CONSTA (Risperidone Long-Acting Intramuscular Injection) in adult patients with schizophrenia. The total duration of the study will be approximately 14 weeks. For those patients without source documentation of tolerability to oral (by mouth) risperidone or paliperidone Extended Release (ER) tablets, injectable RISPERDAL CONSTA or paliperidone palmitate, or those patients who were not currently taking another antipsychotic, a minimum of 4 days and a maximum of 6 days of oral paliperidone ER treatment at a dosage of 6 mg/day will be administered for tolerability testing before the first injection of double-blind (DB) study drug (paliperidone palmitate or RISPERDAL CONSTA). During the DB period, study drug will be administered to patients as an intramuscular (i.m.) injection. Paliperidone palmitate (PP) 150mg equivalent (eq) (and RISPERDAL CONSTA placebo) at Baseline (BL) (Day 1), 100mg eq at Visit (V) 4 (Day 8), 50 or 100mg eq at V7 (Day 36), and 50,100,or 150mg eq at V9 (Day 64) or RISPERDAL CONSTA (RC) 25mg at V4 and V6 (Day 22), 25 or 37.5mg at V7, and 25, 37.5, or 50mg at V9 will be given as i.m. injections. Patients in the RC group will also take risperidone tablets (1-6 mg/day) at BL for 28 days and be given an injection of PP placebo at BL, V1, V7, and V9.

Arms:
arm 1: RISPERDAL CONSTA 25-50 mg eq every 2 weeks arm 2: Paliperidone Palmitate 50-150 mg eq every 4 wks

Interventions: intervention 1: RISPERDAL CONSTA intervention 2: Paliperidone palmitate
Intervention descriptions: intervention 1: RISPERDAL CONSTA: Type=exact number, unit=mg, number=25, 37.5, or 50, form=suspension for injection, route=Intramuscular use. One i.m. injection of RISPERDAL CONSTA 25-50 mg eq every 2 weeks at V4, V6, V7, V8, V9, and V10. PALIPERIDONE PALMITATE PLACEBO: Form=suspension for injection, route=Intramuscular use. One i.m. injection every 2 weeks at Baseline and at V4, V7, and V9. RISPERIDONE: Type=up to, unit=mg, number=1 to 6, form=Tablet, route=Oral Use. One tablet for the first 4 weeks (28 days) of the DB treatment period. intervention 2: PALIPERIDONE PALMITATE: Type=exact number, unit=mg, number=50, 100, or 150, form=suspension for injection, route=Intramuscular use. One i.m. injection of Paliperidone palmitate 50-150 mg eq every 4 wks at Baseline, V4, V7, and V9. RISPERDAL CONSTA PLACEBO: Form=suspension for injection, route=Intramuscular use. One i.m. injection every 4 weeks at Baseline, V4, V7, and V9.

Protocol document: