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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