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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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.

Enrollment:	13
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 & 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

ClinicalTrials.gov Identifier:	NCT00076115 History of Changes
Other Study ID Numbers:	CR003631
Study First Received:	January 14, 2004
Last Updated:	June 6, 2011
Health Authority:	United States: Food and Drug Administration

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

Bipolar
Mania
Manic
Depressive
Manic Depressive

Bipolar mania
risperidone
adolescents
children

Additional relevant MeSH terms:

Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on February 13, 2012