Study to Determine the Effectiveness of Risperidone in Bipolar Disorder in Children and Adolescents

June 6, 2011 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Research on the Effectiveness of Risperidone in Bipolar Disorder in Adolescents and Children (REACH): A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Risperidone for the Treatment of Acute Mania in Bipolar I Disorder

A clinical study to determine the safety and effectiveness of risperidone compared with placebo in the treatment of bipolar disorder (manic or mixed type) in children and adolescents aged 10 to 17 years.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects will be aged 10 to 17 years with a diagnosis of Bipolar I disorder and suffering from a current mixed or manic episode. On enrollment, subjects will be assigned to receive 1 of 3 treatments (oral placebo tablets, oral risperidone tablets 0.5 to 2.5 mg, or oral risperidone tablets 3 to 6 mg), which will be administered daily for 3 weeks. Study medication will be increased to the target dosage during the first 7 days, then further increased within the target dosage range reached until maximum tolerated dose is reached by day 10. The maximum tolerated dose will be given for the last 12 days of the study. Risperidone (0.5 to 2.5 mg or 3 to 6 mg doses) or placebo given orally as 0.25, 0.5, 1, 2, 3, or 4 mg tablets (or matching placebo) each day for 3 weeks.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Current primary diagnosis of bipolar I disorder, mania or mixed type
  • Aged between 10 and 17 years
  • Young Mania Rating Scale score greater than or equal to 20 at screening and baseline

Exclusion Criteria:

  • Known or suspected history of substance dependence
  • Significant risk for suicidal or violent behavior
  • Received electroconvulsive treatment within 4 weeks of baseline
  • Received a depot antipsychotic within 2 treatment cycle before baseline
  • Is unable to swallow medication taken in the form of tablets
  • Has a positive result for a urine drug screen done at baseline
  • Known or suspected seizure disorder
  • Hypothyroidism or hyperthyroidism, unless stabilized on appropriate medication for at least 3 months before screening
  • Known or suspected history of hypersensitivity or intolerance to risperidone
  • History of a poor antimanic response to risperidone when used in adequate doses for an adequate period as the sole antimanic agent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The change in the total YMRS score from baseline at the 3-week endpoint

Secondary Outcome Measures

Outcome Measure
Effects on secondary efficacy variables (YMRS response and onset of maintained response, Clinical Global Impression Scale - Bipolar Disorder [CGI-BP]), safety, tolerability, and pharmacokinetics.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

January 14, 2004

First Submitted That Met QC Criteria

January 15, 2004

First Posted (Estimate)

January 16, 2004

Study Record Updates

Last Update Posted (Estimate)

June 8, 2011

Last Update Submitted That Met QC Criteria

June 6, 2011

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR003631

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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