Conditions: Schizophrenia
Keywords: Schizophrenia JNS007ER Positive and Negative Syndrome Scale (PANSS) Paliperidone Extended Release Osmotic Controlled-Release Oral Delivery System (OROS) paliperidone
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 394
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the effectiveness and safety of Extended Release Osmotic Controlled-Release Oral Delivery System (OROS) Paliperidone compared to placebo in patients with Schizophrenia. Olanzapine will be used as a reference drug in the study.

Detailed description:
This is a multicenter, double blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), randomized (patients are assigned different treatments based on chance), placebo- and active-controlled, parallel-group study. Patients will be randomized into 1 of 3 treatment groups to receive oral dosages of Extended Release (ER) Osmotic Controlled-Release Oral Delivery System (OROS) paliperidone 6 mg, olanzapine 10 mg, or placebo. They will receive two capsules of Paliperidone ER 3 mg, placebo or Olanzapine 5 mg once daily after breakfast for 6 weeks. The study will include a screening period, followed by double-blind treatment for 6 weeks.

Arms:
arm 1: Extended Release (ER) Osmotic Controlled-Release Oral Delivery System (OROS) paliperidone arm 2: None arm 3: None

Interventions: intervention 1: ER OROS paliperidone intervention 2: Placebo intervention 3: Olanzapine
Intervention descriptions: intervention 1: Type= exact number, unit= mg, number= 3, form= tablet, route= oral use. Two tablets once daily for 6 weeks. intervention 2: Form= tablet, route= oral use. Two tablets once daily for 6 weeks. intervention 3: Type= exact number, unit= mg, number= 2.5, form= tablet, route= oral use. Four tablets once daily for 6 weeks.

Protocol document: