Study of Outcome and Safety of Lithium, Divalproex and Risperidone for Mania in Children and Adolescents
- Conditions
- Bipolar Disorder
- Interventions
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 379
- 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
- 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
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 worse, 7=very much worse.
- 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 (functioning is significantly impaired because of side effects). Items for cardiovascular, gastrointestinal, central nervous system, ocular, mouth and nose, genito urinary, dermatology, musculo-skeletal, and other side effects are included. For analyses, side effects that were reported at any frequency and a severity of 2 or greater were considered present.
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 worse mania. The maximum possible score is 64.
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