NCT00391222

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

Completed Phase 3 Results posted Last updated 24 April 2014

What this trial tests

Phase 3 trial testing Olanzapine in Bipolar Disorder in 585 participants. Completed in 1 April 2009.

Timeline

1 November 2006

Primary endpoint
1 April 2009

1 April 2009

Quick facts

Lead sponsor	Janssen Pharmaceutica N.V., Belgium
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	585
Start date	1 November 2006
Primary completion	1 April 2009
Estimated completion	1 April 2009
Sites	63 locations across China, Colombia, Germany, Greece, India, Indonesia, Jordan, Lebanon

Drugs / interventions tested

• Olanzapine (olanzapine) — full drug profile →
• Placebo
• Risperidone Long Acting Injectable (LAI) — full drug profile →

Conditions studied

• Bipolar Disorder — all drugs for Bipolar Disorder →

Sponsor

Janssen Pharmaceutica N.V., Belgium — full company profile →

Who can join

Adults 18 to 65, any sex, with Bipolar Disorder. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Time to Recurrence of a Mood Episode (Risperidone LAI Versus Placebo)
  Time frame: Assessed at every visit from the moment of randomization to a treatment arm (baseline Period III) until the end of treatment (Month 21 or earlier)
  Recurrence was estimated using the Kaplan-Meier method and defined as meeting any of the following: DSM-IV-TR criteria for a hypomanic, manic, mixed, or depressive episode; in need of mood stabilizer, antipsychotic medication, benzodiazepine or antidepressant; requiring hospitalization for mood episode; either Young Mania Rating Scale (YMRS) \>12 or Montgomery-Åsberg Depression Rating Scale (MADRS

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Depicting Risperidone Safety Profiles in Clinical Trials Across Different Diagnoses Using a Dopamine D₂-Based Pharmacological Class Effect Query Defined by FAERS.
   Hopkins SC, Ogirala A, Zeni C, Worden M, et al · · 2022 · cited 3× · PMID 36350559 · DOI 10.1007/s40261-022-01218-7