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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