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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00057681 |
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 |
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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 |
Estimated Enrollment: | 400 |
Study Start Date: | February 2003 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants will receive treatment with lithium for 8 to 16 weeks
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Drug: Lithium carbonate
Titrated until blood level is 1.1 to 1.3 mEq/L
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2: Experimental
Participants will receive treatment with valproate for 8 to 16 weeks
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Drug: Valproate
Titrated until blood level is 111 to 125 ug/mL
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3: Experimental
Participants will receive treatment with risperidone for 8 to 16 weeks
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Drug: Risperidone
Titrated by weight until dose is 2.0 mg BID to 3.0 mg BID
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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.
Ages Eligible for Study: | 6 Years to 15 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Barbara Geller, MD | gellerb@medicine.wustl.edu |
United States, District of Columbia | |
Children's National Medical Center | Recruiting |
Washington, District of Columbia, United States, 20010 | |
Contact: Thalia Attinger 202-884-2681 pjoshi@cnmc.org | |
Principal Investigator: Paramjit Joshi, MD | |
United States, Maryland | |
Johns Hopkins Medical Center | Recruiting |
Baltimore, Maryland, United States, 21287 | |
Contact: Sam Walford, MA 410-955-1542 swalford@jhmi.edu | |
Principal Investigator: John Walkup, MD | |
United States, Missouri | |
Washington University School of Medicine | Recruiting |
St. Louis, Missouri, United States, 63110-1093 | |
Contact: Samantha Blankenship, MSW 314-286-2783 blankens@msnotes.wustl.edu | |
Principal Investigator: Joan Luby, MD | |
United States, Pennsylvania | |
University of Pittsburgh/WPIC | Recruiting |
Pittsburgh, Pennsylvania, United States, 15208 | |
Contact: Annette Baughman 800-518-0370 baughmanam@msx.upmc.edu | |
Principal Investigator: David Axelson, MD | |
United States, Texas | |
University of Texas | Recruiting |
Galveston, Texas, United States, 77555 | |
Contact: Jennifer Ferguson, MSW 281-335-5403 jdfergus@utmb.edu | |
Principal Investigator: Karen Wagner, MD |
Principal Investigator: | Barbara Geller, MD | Washington University in St. Louis |
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: | September 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00057681 |
Health Authority: | United States: Federal Government |
Mania |
Affective Disorders, Psychotic Dopamine Mental Disorders Bipolar Disorder Risperidone Mood Disorders |
Lithium Carbonate Psychotic Disorders Valproic Acid Serotonin Lithium |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Dopamine Antagonists Enzyme Inhibitors Antimanic Agents |
Antipsychotic Agents Pharmacologic Actions Serotonin Antagonists Serotonin Agents Therapeutic Uses Dopamine Agents Central Nervous System Agents Antidepressive Agents |