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A Study to Evaluate the Efficacy and Safety of Risperidone for the Prevention of Mood Episodes in the Treatment of Patients With Bipolar I Disorder

NCT00391222 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 585

Last updated 2014-05-09

Study results available
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Summary

The purpose of this randomized, double blind, double dummy, multicenter study was to evaluate the efficacy of risperidone long-acting injectable (LAI) monotherapy in comparison with placebo in the prevention of a mood episode in treatment of patients with bipolar I disorder. Oral olanzapine was used to assess the validity of the study design. The primary objective of this study is to evaluate the efficacy of risperidone LAI versus placebo in the prevention of a mood episode (recurrence event) in patients with bipolar I disorder after a 12-week (3 month) stabilization period on risperidone LAI, as measured by the time to recurrence of any mood episode. Risperidone LAI has been approved by the FDA in the USA for the treatment of patients with schizophrenia and for the prevention of mood recurrences in bipolar I disorder, as monotherapy or add-on treatment. It is approved at EMEA and other European and non-European health authorities for the treatment of patients with schizophrenia, too.

Conditions

Interventions

DRUG

Olanzapine

Intramuscular injections of placebo every 2 weeks and oral olanzapine 10 mg daily

DRUG

Placebo

Intramuscular injections of placebo every 2 weeks and oral placebo daily

DRUG

Risperidone Long Acting Injectable (LAI)

Intramuscular injections of risperidone LAI (25, 37.5, or 50 mg) every 2 weeks and oral placebo daily

Sponsors & Collaborators

  • Janssen Pharmaceutica N.V., Belgium

    lead INDUSTRY

Principal Investigators

  • Janssen Pharmaceutica N.V. Clinical Trial · Janssen Pharmaceutica N.V.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • China
  • Colombia
  • Germany
  • Greece
  • India
  • Indonesia
  • Jordan
  • Lebanon
  • Malaysia
  • Mexico
  • Peru
  • Philippines
  • Russia
  • South Africa
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00391222 on ClinicalTrials.gov