Study to Determine the Effectiveness of Risperidone in Bipolar Disorder in Children and Adolescents - Full Text View

Sponsor:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00076115

Purpose

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.

Condition	Intervention	Phase
Bipolar Disorder	Drug: Risperidone	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Risperidone

U.S. FDA Resources

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	162
Study Start Date:	December 2003
Study Completion Date:	December 2005

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.

Eligibility

Ages Eligible for Study:	10 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00076115

Sponsors and Collaborators

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

Investigators

Study Director:

Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial

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

More Information

Additional Information:

Study to Determine the Effectivness of Risperidone in Bipolar Disorder in Children and Adolescents This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CR003631
Study First Received:	January 14, 2004
Last Updated:	March 28, 2008
ClinicalTrials.gov Identifier:	NCT00076115 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

adolescents
risperidone
Mania
Depressive
Manic

Bipolar mania
Bipolar
Manic Depressive
children

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Disease
Molecular Mechanisms of Pharmacological Action
Bipolar Disorder
Physiological Effects of Drugs
Psychotropic Drugs
Risperidone
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents

Pharmacologic Actions
Affective Disorders, Psychotic
Serotonin Antagonists
Pathologic Processes
Serotonin Agents
Mental Disorders
Therapeutic Uses
Mood Disorders
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009