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A Study to Evaluate Effectiveness and Safety of ER OROS Paliperidone in Patients With Schizophrenia

Janssen (J&J Innovative Medicine) logo

Janssen (J&J Innovative Medicine)

Status and phase

Completed
Phase 3

Conditions

Schizophrenia

Treatments

Drug: Placebo
Drug: Olanzapine
Drug: ER OROS paliperidone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00396565
JNS007ER-JPN-S31 (Other Identifier)
CR012625

Details and patient eligibility

About

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.

Full 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.

Enrollment

394 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients who have given their own consent in writing to participate in the study
  • Patients diagnosed with schizophrenia according to the diagnostic criteria of DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 295.30, 295.10, 295.20, 295.90, 295.60)
  • Patients who have acute symptoms of schizophrenia
  • Both inpatients and outpatients are acceptable

Exclusion criteria

  • A DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) of a mental disease diagnosis other than schizophrenia
  • A DSM-IV diagnosis of substance-related disorder (except nicotine dependence and caffeine dependence) within 180 days before the screening test
  • Total PANSS (Positive and Negative Syndrome System) score at the screening test <70 or >120
  • Patients treated with three or more types of antipsychotic within 28 days before the screening test
  • Parkinson's disease (except for those with drug-induced extra pyramidal symptoms)
  • Patients with a complication of or a past history of cerebrovascular accident
  • Patients with a complication of or a past history of diabetes mellitus

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

394 participants in 3 patient groups, including a placebo group

ER OROS paliperidone
Experimental group
Description:
Extended Release (ER) Osmotic Controlled-Release Oral Delivery System (OROS) paliperidone
Treatment:
Drug: ER OROS paliperidone
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo
Olanzapine
Active Comparator group
Treatment:
Drug: Olanzapine

Trial contacts and locations

56

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Data sourced from clinicaltrials.gov

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