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| 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 |
| MedlinePlus related topics: | Bipolar Disorder |
| ChemIDplus related topics: | Risperidone Divalproex sodium Valproate Sodium Valproic acid Lithium carbonate Lithium citrate |
| 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 |
|
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.
Eligibility
| Ages Eligible for Study: | 6 Years to 15 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| 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 |
| First Received: | April 4, 2003 |
| Last Updated: | February 13, 2008 |
| ClinicalTrials.gov Identifier: | NCT00057681 |
| Health Authority: | United States: Federal Government |
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