Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): PP3M 175 mg eq.; PP3M 263 mg eq.; PP3M 350 mg eq.; PP3M 525 mg eq.; Placebo (20% Intralipid); PP1M 50 mg eq.; PP1M 75 mg eq.; PP1M 100 mg eq.; PP1M 150 mg eq.
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Type= exact number, unit= mg eq., number= 175, form= injection, route= intramuscular use. One injection every third month for 48 weeks.; Type= exact number, unit= mg eq., number= 263, form= injection, route= intramuscular use. One injection every third month for 48 weeks.; Type= exact number, unit= mg eq., number= 350, form= injection, route= intramuscular use. One injection every third month for 48 weeks.; Type= exact number, unit= mg eq., number= 525, form= injection, route= intramuscular use. One injection every third month for 48 weeks.; Form= injection, route= intramuscular use. One injection monthly when not receiving active medication for 48 weeks.; Type= exact number, unit= mg eq., number= 50, form= injection, route= intramuscular use. One injection every month for 48 weeks.; Type= exact number, unit= mg eq., number= 75, form= injection, route= intramuscular use. One injection every month for 48 weeks.; Type= exact number, unit= mg eq., number= 100, form= injection, route= intramuscular use. One injection every month for 48 weeks.; Type= exact number, unit= mg eq., number= 150, form= injection, route= intramuscular use. One injection every month for 48 weeks.
Intervention MeSH terms: Soybean oil, phospholipid emulsion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Schizophrenia; R092670; Paliperidone Palmitate; Paliperidone palmitate 1 month formulation (PP1M); Paliperidone palmitate 3 month formulation (PP3M)