Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
National Institute of Mental Health (NIMH) University of Cincinnati |
---|---|
Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00221429 |
This study will compare the efficacy of lithium, divalproex, and placebo in treating the acute phase of symptomatic bipolar I disorder, mixed or manic episode, in children and adolescents.
Condition | Intervention | Phase |
---|---|---|
Bipolar Disorder |
Drug: lithium sodium divalproex |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Pediatric Bipolar Collaborative Mood Stabilizer Trial |
Estimated Enrollment: | 154 |
Study Start Date: | March 2001 |
Primary Aim:
To compare the efficacy of LI, DVP, and PBO in the acute phase treatment of symptomatic bipolar I disorder, mixed or manic episode, in children and adolescents. Our hypothesis is that differential efficacy will be observed with the following predicted order of response: DVP = LI > PBO.
Secondary Aims:
Ages Eligible for Study: | 7 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients who have a positive drug screen at intake, who would otherwise be eligible for the study, will be given the opportunity to repeat the drug screen 3 weeks later. They will be excluded if the second drug screen is positive.
7. Pregnancy or sexually active females not using a reliable form of contraception 8. Previous adequate trial of either LI or DVP defined as; 3 weeks of DVP at serum levels between 75-125 OR dosage of at least 20 mg/kg; Lithium for at least 4 weeks at serum levels of .8 – 1.2 or dosage of at least 30 mg/kg. 9. Allergies to LI, DVP or chlorpromazine. 10. Bipolar subjects who are currently stable on mood stabilizers or atypical neuroleptics.
11. Bipolar subjects with Bipolar I disorder and ADHD who are stable on stimulants with or without concurrent mood stabilizers.
12. Inpatient hospitalization within 6 months prior to screening. Partial hospitalization is acceptable.
United States, Ohio | |
University of Cincinnati Medical Center/Medical Sciences Building | |
Cincinnati, Ohio, United States, 45267 |
Principal Investigator: | Robert A Kowatch, MD | University of Cincinnati |
Study ID Numbers: | R01 MH63632, DSIR CT-M |
Study First Received: | September 14, 2005 |
Last Updated: | February 22, 2006 |
ClinicalTrials.gov Identifier: | NCT00221429 History of Changes |
Health Authority: | United States: Federal Government |
child adolescent |
Affective Disorders, Psychotic Tranquilizing Agents Mental Disorders Bipolar Disorder Psychotropic Drugs Mood Disorders |
Central Nervous System Depressants Lithium Carbonate Psychotic Disorders Antimanic Agents Antipsychotic Agents Lithium |
Disease Tranquilizing Agents Bipolar Disorder Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Antimanic Agents Antipsychotic Agents |
Pharmacologic Actions Affective Disorders, Psychotic Pathologic Processes Mental Disorders Therapeutic Uses Mood Disorders Central Nervous System Agents Lithium |