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Awarded Trial: 00-032

Grant ID

00-032

Illness

Bipolar Disorder

Primary Drug/Intervention

Topiramate + Olanzapine

Primary Dosage

25-100 mg/day

Secondary Drug Intervention

Olanzapine

Secondary Dosage

2.5-20 mg/day

Other Drug/Intervention

N/A

Other Dosage

N/A

Status

Completed

Investigator

Wozniak

Sample Size

40

Duration of Study Period for Each Subject

8 weeks

Outcome Measurements

YMRS

Results

In an eight week open label study, 16 youths aged 5 to 18 years received treatment with olanzapine (2.5-20 mg per day) and 18 youths received olanzapine plus topiramate (25-100 mg per day). All patients had mania or mixed mania. Both groups showed improvement in symptoms of mania, but there was no significant benefit of adjunctive topiramate on YMRS scores. Patients who received topiramate gained less weight than those who did not, but the difference did not reach statistical significance.

Publication

Wozniak J, Mick E, Waxmonsky J, Kotarski M, Hantsoo L, Biederman J. Comparison of open-label, 8-week trials of olanzapine monotherapy and topiramate augmentation of olanzapine for the treatment of pediatric bipolar disorder. J Child Adolesc Psychopharmacol. 2009 Oct;19(5):539-45.

Link

http://www.ncbi.nlm.nih.gov/pubmed/19877978

PI Name

Janet Wozniak

Degree

MD

Center

Massachusetts General Hospital

Institution

Massachusetts General Hospital, ACC 725

Address

15 Parkman Street

City or Town

Boston

State or Province

MA

Zip or Postal Code

2114

Country

USA

Email Address

jwozniak@partners.org