Not Signed In -
Bipolar Disorder |
Manic-Depressive Illness |
Clinical Trial: Treatment of Early Age Mania
This study is currently recruiting patients.
|
Purpose
The purpose of this study is to evaluate the effectiveness of the drugs lithium, valproate, and risperidone in treating children and adolescents with bipolar disorder or symptoms of mania.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Bipolar Disorder Manic Disorder | Drug: Lithium Drug: Valproate Drug: Risperidone | Phase III |
MedlinePlus related topics: Bipolar Disorder
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Treatment of Early Age Mania (TEAM) Study
Expected Total Enrollment: 540
Study start: February 2003; Expected completion: December 2007
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.
Eligibility
Ages Eligible for Study: 6 Years - 14 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- DSM-IV criteria for bipolar I (manic or mixed) or mania for at least 4 weeks
- CGAS <= 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 < 70
- Pregnancy or breast-feeding
- Unacceptable methods of contraception
- In-patient care at baseline
Location and Contact Information
District of Columbia
Children's National Medical Center, Washington, District of Columbia, 20010, United States; Recruiting
Paramjit Joshi, MD, Principal Investigator
Maryland
Johns Hopkins Medical Center, Baltimore, Maryland, United States; Recruiting
John Walkup, MD, Principal Investigator
Missouri
Washington University School of Medicine, St. Louis, Missouri, United States; Recruiting
Joan Luby, MD, Principal Investigator
Pennsylvania
University of Pittsburgh/WPIC, Pittsburgh, Pennsylvania, United States; Recruiting
David Axelson, MD, Principal Investigator
Texas
University of Texas, Galveston, Texas, United States; Recruiting
Cheryl Pierce, MA 281.335.4764 crpierce@utmb.edu
Karen Wagner, MD, Principal Investigator
More Information
Record last reviewed: March 2005
Last Updated: March 24, 2005
Record first received: April 4, 2003
ClinicalTrials.gov Identifier: NCT00057681
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- About Early-Onset Bipolar Disorder (Child & Adolescent Bipolar Foundation)
- Accommodating Workers with Bipolar Disorder (Job Accommodation Network)
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