Clinical trial

A Study to Evaluate the Efficacy and Safety of Risperidone for the Prevention of…

NCT00391222 · Janssen Pharmaceutica N.V., Belgium, Industry · Completed

Key facts

NCT number NCT00391222
Title 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
Official title A Randomized, Double Blind, Placebo and Active Controlled Parallel Group Study to Evaluate the Efficacy and Safety of Risperidone Long-acting Injectable (LAI) for the Prevention of Mood Episodes in the Treatment of Subjects With Bipolar I Disorder
Lead sponsor Janssen Pharmaceutica N.V., Belgium, Industry
Status Completed
Phase Phase 3
Study type Interventional
Conditions Bipolar Disorder
Intervention type Drug
Interventions Olanzapine, Placebo, Risperidone Long Acting Injectable (LAI)
Enrollment 585
Start date Nov 1, 2006
Primary completion Apr 1, 2009
Completion Apr 1, 2009
First posted Oct 23, 2006
Last update posted May 9, 2014
Countries China, Colombia, Germany, Greece, India, Indonesia, Jordan, Lebanon, Malaysia, Mexico, Peru, Philippines and 3 more

At a glance

  • Yes Results posted
  • None Linked FDA submissions

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date:

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