Treatment of Early Age Mania (TEAM) Study
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 379
- Locations
- 5
- Primary Endpoint
- Clinical Global Impressions-Bipolar Mania Improvement
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 15 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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
Arms & Interventions
1
Participants will receive treatment with lithium for 8 to 16 weeks
Intervention: Lithium carbonate (Drug)
2
Participants will receive treatment with valproate for 8 to 16 weeks
Intervention: Valproate (Drug)
3
Participants will receive treatment with risperidone for 8 to 16 weeks
Intervention: Risperidone (Drug)
Outcomes
Primary Outcomes
Clinical Global Impressions-Bipolar Mania Improvement
Time Frame: 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 Outcomes
- Modified Side Effects Form for Children and Adolescents(Measured at Week 8)
- K-SADS Mania Rating Scale(Measured at Week 8)