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Treatment of Early Age Mania
This study has been completed.
First Received: April 4, 2003   Last Updated: March 9, 2009   History of Changes
Sponsored by: 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 III

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

Resource links provided by NLM:


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
1: Experimental
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
2: Experimental
Participants will receive treatment with valproate for 8 to 16 weeks
Drug: Valproate
Titrated until blood level is 111 to 125 ug/mL
3: Experimental
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

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
Investigators
Principal Investigator: Barbara Geller, MD Washington University in St. Louis
  More Information

Publications:
Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Responsible Party: Washington University in St. Louis ( Barbara Geller, MD )
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
ClinicalTrials.gov Identifier: NCT00057681     History of Changes
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Neurotransmitter Agents
Tranquilizing Agents
Bipolar Disorder
Risperidone
Psychotropic Drugs
Central Nervous System Depressants
Lithium Carbonate
Antipsychotic Agents
Antimanic Agents
Valproic Acid
Serotonin
Affective Disorders, Psychotic
Dopamine
Mental Disorders
Mood Disorders
Dopamine Agents
Psychotic Disorders
Lithium
Antidepressive Agents

Additional relevant MeSH terms:
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Bipolar Disorder
Physiological Effects of Drugs
Risperidone
Psychotropic Drugs
Central Nervous System Depressants
Lithium Carbonate
Dopamine Antagonists
Enzyme Inhibitors
Antipsychotic Agents
Antimanic Agents
Pharmacologic Actions
Serotonin Antagonists
Affective Disorders, Psychotic
Serotonin Agents
Mental Disorders
Therapeutic Uses
Mood Disorders
Dopamine Agents
Central Nervous System Agents
Lithium
Antidepressive Agents

ClinicalTrials.gov processed this record on July 02, 2009