Treatment of Early Age Mania - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00057681

Purpose

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.

Condition	Intervention	Phase
Bipolar Disorder	Drug: Lithium carbonate Drug: Valproate Drug: Risperidone	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Treatment of Early Age Mania (TEAM) Study

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Valproic acid Lithium carbonate Valproate Sodium Lithium citrate Divalproex sodium Risperidone

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	400
Study Start Date:	February 2003
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Participants will receive treatment with lithium for 8 to 16 weeks	Drug: Lithium carbonate Titrated until blood level is 1.1 to 1.3 mEq/L
Experimental: 2 Participants will receive treatment with valproate for 8 to 16 weeks	Drug: Valproate Titrated until blood level is 111 to 125 ug/mL Other Name: Depakote
Experimental: 3 Participants will receive treatment with risperidone for 8 to 16 weeks	Drug: Risperidone Titrated by weight until dose is 2.0 mg BID to 3.0 mg BID Other Name: Risperdal

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.

Eligibility

Ages Eligible for Study:	6 Years to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00057681

Locations

United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Maryland
Johns Hopkins Medical Center
Baltimore, Maryland, United States, 21287
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110-1093
United States, Pennsylvania
University of Pittsburgh/WPIC
Pittsburgh, Pennsylvania, United States, 15208
United States, Texas
University of Texas
Galveston, Texas, United States, 77555

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Barbara Geller, MD

Washington University in St. Louis

More Information

Publications:

Tillman R, Geller B, Klages T, Corrigan M, Bolhofner K, Zimerman B. Psychotic phenomena in 257 young children and adolescents with bipolar I disorder: delusions and hallucinations (benign and pathological). Bipolar Disord. 2008 Feb;10(1):45-55.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Tillman R, Geller B. Diagnostic characteristics of child bipolar I disorder: does the "Treatment of Early Age Mania (team)" sample generalize? J Clin Psychiatry. 2007 Feb;68(2):307-14.

Responsible Party:	Barbara Geller, MD, Washington University in St. Louis
ClinicalTrials.gov Identifier:	NCT00057681 History of Changes
Other Study ID Numbers:	U01 MH64846, DDTR B4-ARM, U01 MH64851, U01 MH64911, U01 MH64868, U01 MH64887, U01 MH64850, U01 MH64869, DPTR B4-ARM
Study First Received:	April 4, 2003
Last Updated:	March 9, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Mania

Additional relevant MeSH terms:

Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Valproic Acid
Lithium Carbonate
Lithium
Risperidone
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Antidepressive Agents
Antipsychotic Agents
Serotonin Antagonists
Serotonin Agents
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on May 21, 2012