Study of Outcome and Safety of Lithium, Divalproex and Risperidone for Mania in Children and Adolescents

Phase 3

Completed

• Conditions: Bipolar Disorder
• Interventions: Drug: Lithium carbonate; Drug: Valproate; Drug: Risperidone

• Registration Number: NCT00057681
• Lead Sponsor: Washington University School of Medicine

Brief Summary

This study will evaluate the effectiveness of the medications, lithium (Eskalith®), valproate (Depakote®), and risperidone (Risperdal®) in treating children and adolescents with bipolar disorder or symptoms of mania.

Detailed Description

Patients are randomly assigned to receive lithium (Eskalith), valproate (Depakote), or risperidone (Risperdal) for 8 to 16 weeks. They will have weekly visits to monitor their response to the medication. When the study is complete, care will be transferred to the child's treating psychiatrist.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2003-02
• Study First Submitted: 2003-04-04
• Study First Submitted QC: 2003-04-04
• Study First Posted: 2003-04-08
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Results First Submitted: 2012-05-29
• Results First Submitted QC: 2013-02-13
• Status Verified: 2013-03
• Results First Posted: 2013-03-27
• Last Update Submitted: 2013-03-27
• Last Update Posted: 2013-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 379

Inclusion Criteria

• DSM-IV criteria for bipolar I (manic or mixed) or mania for at least 4 weeks
• CGAS less than or equal to 60
• Good physical health

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Exclusion Criteria

• Schizophrenia or any pervasive developmental disorder
• Major medical or neurological disease
• History of addiction to illicit substances or alcohol or drug abuse within the last 4 weeks
• IQ less than 70
• Pregnancy or breast-feeding
• Unacceptable methods of contraception
• In-patient care at baseline

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Lithium carbonate	Participants will receive treatment with lithium for 8 to 16 weeks
2	Valproate	Participants will receive treatment with valproate for 8 to 16 weeks
3	Risperidone	Participants will receive treatment with risperidone for 8 to 16 weeks

Primary Outcome Measures

Name	Time	Method
Clinical Global Impressions-Bipolar Mania Improvement	Measured at Week 8	The Clinical Global Impressions-Bipolar (CGI-BP) assessment instrument measured improvement in mania, depression, and overall bipolar illness. The primary outcome measure was mania improvement, which measured the change in mania from baseline. Scores were 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much wors...

Secondary Outcome Measures

Name	Time	Method
Modified Side Effects Form for Children and Adolescents	Measured at Week 8	The Modified Side Effects Form for Children and Adolescents includes 62 potential side effects, with measures of frequency and severity for each item. Frequencies are 0=not present, 1=1-2 days, 2=3-4 days, 3=5-7 days. Severity scores are 0=not present, 1=mild (does not interfere with functioning), 2=moderate (some interference with functioning), 3=severe (fu...
K-SADS Mania Rating Scale	Measured at Week 8	The K-SADS Mania Rating Scale (KMRS) is comprised of 15 items modified from WASH-U-KSADS items. The individual items are scored on a 1-6 severity scale and then these item scores are summed to create an overall KMRS score. Guidelines for interpretation are as follows: 0-11 = no or minimal mania, 12-17 = mild mania, 18-25 = moderate mania, 26+ = marked or wor...

Trial Locations

Locations (5)

University of Pittsburgh/WPIC; 🇺🇸 Pittsburgh, Pennsylvania, United States

Johns Hopkins Medical Center; 🇺🇸 Baltimore, Maryland, United States

Children's National Medical Center; 🇺🇸 Washington, District of Columbia, United States

University of Texas; 🇺🇸 Galveston, Texas, United States

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States