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Awarded Trial: 97-RC-301-2
Grant ID
97-RC-301-2
Illness
Bipolar Disorder
Primary Drug/Intervention
Divalproex
Primary Dosage
N/A
Secondary Drug Intervention
Lithium
Secondary Dosage
N/A
Other Drug/Intervention
N/A
Other Dosage
N/A
Status
Completed
Investigator
Findling
Sample Size
53
Duration of Study Period for Each Subject
up to 5 months
Outcome Measurements
YMRS, CDRS-R, CGAS
Results
Fifty-three offspring of a parent with bipolar disorder (aged 5-17) and meeting diagnostic criteria for cyclothymia or bipolar disorder not otherwise specified were randomized to receive divalproex or placebo for up to 5 years. There was no significant difference between the two groups for time to relapse. In a post-hoc analysis, patients with the greatest degree of genetic risk tended to respond better to divalproex than to placebo.
Publication
Findling RL, Frazier TW, Youngstrom EA, McNamara NK, Stansbrey RJ, Gracious BL, Reed MD, Demeter CA, Calabrese JR. Double-Blind, Placebo-Controlled Trial of Divalproex Monotherapy in the Treatment of Symptomatic Youth at High Rish for Developing Bipolar Disorder. Journal of Clinical Psychiatry 68:5, 781-788, 2007.
Link
http://www.ncbi.nlm.nih.gov/pubmed/17503990
PI Name
Robert Findling
Degree
MD
Center
Case Western Reserve University, Child and Adolescent Psychiatry
Institution
University Hospitals of Cleveland
Address
11100 Euclid Avenue
City or Town
Cleveland
State or Province
OH
Zip or Postal Code
44106
Country
USA
Email Address
robert.findling@uhhs.com