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Treatment of Early Age Mania

This study is currently recruiting participants.
Information provided by National Institute of Mental Health (NIMH)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Treatment of Early Age Mania

Official Title ^†

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 ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

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 ]

Condition ^†

Bipolar Disorder

Intervention ^†

Drug: Lithium carbonate
Drug: Valproate
Drug: Risperidone

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

400

Start Date ^†

February 2003

Completion Date

December 2008

Eligibility Criteria ^†

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 ^††

Contact: Barbara Geller, MD

gellerb@medicine.wustl.edu

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00057681

Organization ID

U01 MH64846

Secondary IDs ^††

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

Study Sponsor ^†

National Institute of Mental Health (NIMH)

Collaborators ^††

Investigators ^†

Principal Investigator:

Barbara Geller, MD

Washington University in St. Louis

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

February 2008

First Received Date ^†

April 4, 2003

Last Updated Date

February 13, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.