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A Study of the Safety and Efficacy of Injectable Risperidone in the Prevention of Bipolar Mood Episodes

NCT00132678 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 559

Last updated 2013-07-29

Study results available
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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.

Conditions

Interventions

DRUG

Risperdal Consta

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

DRUG

Placebo

Matching placebo intramuscular (IM) injection every 2 weeks

Sponsors & Collaborators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2007-10-31
Completion
2007-12-31

Countries

  • United States
  • Austria
  • India
  • Malaysia
  • Poland
  • Russia
  • Slovakia
  • Spain
  • Taiwan
  • Ukraine

Study Locations

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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 NCT00132678 on ClinicalTrials.gov