At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 559 enrolled

Drug / intervention

Risperdal Consta +1 moredrug

Likely dose

Risperidone (Risperdal Consta) 12.5–50 mg intramuscular injection every 2 weeksAI-extracted

Key inclusion· 3

✓Diagnosis of bipolar 1 disorder, currently experiencing a mixed or manic episode or in a stable state
✓At least two or more bipolar mood episodes in the last 2 years (excluding the current episode)
✓Negative pregnancy test at baseline

Key exclusion· 5

✕History of more than 4 mood episodes per year during the last two years
✕Currently experiencing a depressive episode
✕History of antisocial or borderline personality disorder
✕Unstable or serious general medical illness

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00132678

NCT00132678Phase 3Completed

Compare CT.gov

A Randomized, Double-blind, Placebo-controlled Study to Explore the Efficacy and Safety of Risperidone Long-acting Intramuscular Injectable in the Prevention of Mood Episodes in Bipolar 1 Disorder, With Open-label Extension

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·interventional·Posted Aug 22, 2005·Updated Jul 29, 2013

In Brief

A Phase 3 clinical trial evaluating Risperdal Consta and Placebo for Bipolar Disorder. Completed, enrolled 559 participants across 51 sites in 10 countries.

Detailed Summary

The purpose of this study is to determine if risperidone is effective and safe in the prevention of mood episodes in patients with bipolar 1 disorder.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsBipolar Disorder

CountriesAustria, India, Malaysia, Poland, Russia, Slovakia, Spain, Taiwan, Ukraine, United States

Collaborators--

Timeline

Phase 3CompletedFinished

20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartFeb 2005

First PostedAug 2005

Primary CompletionOct 2007

Study CompletionDec 2007

TodayJul 2026

First PostedAug 22, 2005

Enrollment StartFeb 1, 2005

Primary CompletionOct 1, 2007

Study CompletionDec 1, 2007

TodayJul 2, 2026

Enrollment to primary: 2.7 yearsPosted 20.9 years ago

Interventions

Risperdal Constadrug

12.5, 25, 37.5 or 50mg intramuscular (IM) injection every 2 weeks

Placebodrug

Matching placebo intramuscular (IM) injection every 2 weeks