Trial Evaluating Three Fixed Doses of Paliperidone Extended-Release (ER) Tablets and Olanzapine in the Treatment of Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the double-blind phase of this study is to evaluate the efficacy and
      safety of 3 fixed dosages of paliperidone ER (3, 9, and 15 mg/day) compared with placebo in
      adult patients with schizophrenia
    

Detailed description: 
      Paliperidone is being developed as a new therapeutic agent for the treatment of
      schizophrenia. The extended-release (ER) formulation of paliperidone was developed to deliver
      paliperidone at a relatively constant rate over a 24-hour period to improve the tolerability
      profile and decrease the potential for orthostatic hypotension. This study is designed to
      evaluate the efficacy and safety and tolerability of 3 dosages of paliperidone ER compared
      with placebo in adult patients with schizophrenia. This is a multicenter, double-blind,
      randomized, placebo- and active-controlled, parallel-group, dose-response study. Patients
      will be randomized into 1 of 5 treatment groups to receive oral dosages of paliperidone ER 3,
      9, or 15 mg, olanzapine 10 mg, or placebo once daily for a 6-week period. The study includes
      a screening period of up to 5 days, followed by a 6-week double-blind treatment phase.
      Following the double-blind treatment phase, eligible patients (those who have completed the
      6-week double-blind phase or who discontinue due to lack of efficacy after a minimum of 21
      days) may enter the 52-week open-label extension with paliperidone ER monotherapy. While
      patients are hospitalized, efficacy will be assessed twice during the first week and at the
      end of the second week, and after patients are discharged from the hospital, they will return
      to have efficacy and safety assessments performed on a weekly basis through the end of the
      6-week double-blind phase. Efficacy will be evaluated throughout the 6-week double-blind
      phase by completion of the Positive and Negative Syndrome Scale (PANSS), Clinical Global
      Impression Scale - Severity (CGI-S), Personal and Social Performance Scale (PSP), and
      Schizophrenia Quality of Life Scale, Revision 4 (SQLS-R4). The primary efficacy response will
      be measured by the change from baseline score to end of double-blind phase for PANSS total
      score. Safety will be monitored throughout the study and includes assessments of the
      incidence of adverse events; measurement of extrapyramidal symptoms using 3 rating scales
      (Abnormal Involuntary Movement Scale [AIMS], Barnes Akathisia Rating Scale [BARS],
      Simpson-Angus Rating Scale [SAS]); measurement of vital signs (laying down and standing blood
      pressure, pulse, temperature); electrocardiograms; and clinical laboratory tests.
      Double-blind phase: 3, 9, 15 mg of paliperidone ER, 10 mg of olanzapine or placebo taken
      orally once a day for 6 weeks.

      Open-label phase: start on paliperidone ER 9 mg orally once a day; maintained on a flexible
      oral dosage of paliperidone ER (3, 6, 9, 12, or 15 mg/day) for 52 weeks.
    

Intervention name(s): Paliperidone ER
Intervention type(s): Drug
Intervention MeSH terms: Paliperidone Palmitate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Schizophrenia; Paliperidone; Olanzapine; PANSS; Extended release; Atypical neuroleptic