Clinical trial NCT01515423
Conditions: Schizophrenia
Keywords: Schizophrenia R092670 Paliperidone Palmitate Paliperidone palmitate 1 month formulation (PP1M) Paliperidone palmitate 3 month formulation (PP3M)
Sponsor: Janssen Research & Development, LLC
Start date: 2012-05-01; Completion date: 2015-03-01
Enrollment: 1429 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to demonstrate that a paliperidone palmitate 3 month formulation (PP3M) is as effective as the paliperidone palmitate 1 month formulation (PP1M) in the treatment of patients with schizophrenia who have been stabilized on PP1M.

Detailed description:
This is a randomized (the study drug is assigned by chance), double blind (neither physician nor patient knows the treatment that the patient receives), parallel group (each group of patients will be treated at the same time), multicenter non-inferiority (the effect of the new treatment is not worse than that of the comparison treatment) study. A new formulation of paliperidone palmitate with a 3-month injection interval (PP3M) is being tested for use as maintenance treatment for subjects with schizophrenia who have been first stabilized on paliperidone palmitate with a 1-month injection interval (PP1M). The study consists of 3 phases: a screening/washout/tolerability phase (up to 21 days); a 17-week open-label (all people know the identity of the intervention) stabilization phase (referred to as the Open-label Phase) and a 48-week fixed dose, randomized, double-blind controlled phase (referred to as the Double-blind Phase). After completion of the Screening Phase, all patients will receive PP1M in the Open-label Phase. During this time, flexible dosing will occur at Weeks 5 and 9. At Week 13 patients are to receive the dose of PP1M that was administered at Week 9. Patients who are clinically stable at the end of the Open-label Phase will enter the Double-blind Phase and will be randomly assigned in a 1:1 ratio to receive fixed doses of PP3M or PP1M.

Arms: arm 1: A formulation of paliperidone palmitate with a 3-month injection interval arm 2: A formulation of paliperidone palmitate with a 1-month injection interval
Interventions: intervention 1: PP3M 175 mg eq. intervention 2: PP3M 263 mg eq. intervention 3: PP3M 350 mg eq. intervention 4: PP3M 525 mg eq. intervention 5: Placebo (20% Intralipid) intervention 6: PP1M 50 mg eq. intervention 7: PP1M 75 mg eq. intervention 8: PP1M 100 mg eq. intervention 9: PP1M 150 mg eq.
Intervention descriptions: intervention 1: Type= exact number, unit= mg eq., number= 175, form= injection, route= intramuscular use. One injection every third month for 48 weeks. intervention 2: Type= exact number, unit= mg eq., number= 263, form= injection, route= intramuscular use. One injection every third month for 48 weeks. intervention 3: Type= exact number, unit= mg eq., number= 350, form= injection, route= intramuscular use. One injection every third month for 48 weeks. intervention 4: Type= exact number, unit= mg eq., number= 525, form= injection, route= intramuscular use. One injection every third month for 48 weeks. intervention 5: Form= injection, route= intramuscular use. One injection monthly when not receiving active medication for 48 weeks. intervention 6: Type= exact number, unit= mg eq., number= 50, form= injection, route= intramuscular use. One injection every month for 48 weeks. intervention 7: Type= exact number, unit= mg eq., number= 75, form= injection, route= intramuscular use. One injection every month for 48 weeks. intervention 8: Type= exact number, unit= mg eq., number= 100, form= injection, route= intramuscular use. One injection every month for 48 weeks. intervention 9: Type= exact number, unit= mg eq., number= 150, form= injection, route= intramuscular use. One injection every month for 48 weeks.

Protocol documents: