A Randomized, Active-controlled, Double-blind, Parallel-Goup Study of the Efficacy and Safety of Extended Release(ER) Paliperidone in the Treatment of Schizophrenia
Condition: Acute Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized (patients are assigned different treatments based on chance),
      double-blind (neither the patient nor the physician knows whether drug or placebo is being
      taken, or at what dosage), active-controlled, flexible-dose, parallel group, multicenter
      study. The study consists of a screening phase, a double-blind treatment phase (6 weeks) and
      a safety follow-up phase (1 week).

      The patients in this study will be randomized to 1 of 2 treatment groups to receive extended
      release OROS paliperidone or Olanzapine once daily for the 6-week double-blind treatment
      phase. Randomization will occur in a ratio of 1 (extended release OROS paliperidone) to 1
      (Olanzapine). Patients must be hospitalized at least 14 days after entry. Those who receive
      extended release OROS paliperidone will start at a dosage of 6 mg taken daily, dose may be
      titrated up by 3mg/day every 7 days, or down rapidly based on the balance of efficacy
      (effectiveness of drug) and safety/tolerability assessed by the investigator. After the
      initial 7 days, dose could be flexible within 3-12mg/day. Those who receive olanzapine will
      start at a dosage of 5mg taken daily, dose may be titrated up by 5mg/day every 7 days, or
      down rapidly based on the balance of efficacy and safety/tolerability assessed by the
      investigator. After the initial 7 days, dose could be flexible within 5-15mg/day.

      Efficacy parameters include Positive and Negative Symptom Scale (PANSS) score, Clinical
      Global Impression-Severity (CGI-S) and Personal and Social Performance (PSP) score per
      assessment visit. The primary efficacy is the change in PANSS from baseline to the last
      post-randomization assessment. Safety assessments include the adverse events, changes in
      physical examination, vital signs, laboratory tests at pretreatment and posttreatment.
    

Detailed description: 
      The study hypothesis is that the effect of extended release OROS paliperidone is not worse
      than that of Olanzapine in the treatment of schizophrenia as measured by the change in PANSS
      from baseline to the last post-randomization assessment. A flexible dose range is used in
      this study. The flexible dose of paliperidone is ranged from 3 to 12mg/day. The flexible dose
      of olanzapine is ranged from 5-15mg/day.The study medication is capsulized to maintain blind.
      Study medication must be taken orally once daily before 10 AM with or without food in a
      consistent manner throughout the study. Medication can not be chewed, divided, dissolved, or
      crushed. Treatment duration is 6 week each subject.
    

Intervention name(s): ER OROS paliperidone and Olanzapine
Intervention type(s): Drug
Intervention MeSH terms: Olanzapine; Paliperidone Palmitate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Schizophrenia; DSM-IV; PANSS; informed consent