Treatment of Early Age Mania - Tabular View

Tracking Information

First Received Date ^ICMJE

April 4, 2003

Last Updated Date

March 9, 2009

Start Date ^ICMJE

February 2003

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Clinical Global Impressions-Bipolar [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00057681 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Side Effects for Children and Adolescents [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: Yes ]
Mania Rating Scale [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Treatment of Early Age Mania

Official Title ^ICMJE

Treatment of Early Age Mania (TEAM) Study

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 Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Bipolar Disorder

Intervention ^ICMJE

Drug: Lithium carbonate
Drug: Valproate
Drug: Risperidone

Study Arms / Comparison Groups

Experimental: Participants will receive treatment with lithium for 8 to 16 weeks
Experimental: Participants will receive treatment with valproate for 8 to 16 weeks
Experimental: Participants will receive treatment with risperidone for 8 to 16 weeks

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

400

Completion Date

December 2008

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

6 Years to 15 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00057681

Responsible Party

Barbara Geller, MD, Washington University in St. Louis

Study ID Numbers ^ICMJE

U01 MH64846, DDTR B4-ARM, U01 MH64851, U01 MH64911, U01 MH64868, U01 MH64887, U01 MH64850, U01 MH64869, DPTR B4-ARM

Study Sponsor ^ICMJE

National Institute of Mental Health (NIMH)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Barbara Geller, MD

Washington University in St. Louis

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP