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Awarded Trial: 01-RC-310-4
Grant ID
01-RC-310-4
Illness
Bipolar Disorder
Primary Drug/Intervention
Olanzapine
Primary Dosage
4.8 mg/day
Secondary Drug Intervention
Topirimate
Secondary Dosage
117.6 mg/day
Other Drug/Intervention
N/A
Other Dosage
N/A
Status
Completed
Investigator
Vieta
Sample Size
26
Duration of Study Period for Each Subject
one year
Outcome Measurements
YMRS, HAM-D
Results
An investigator selected sample of 26 patients with various bipolar disorders who had a history of poor response to mood stabilizers were followed for one year on a combination of olanzapine and topirimate. A statistically significant reduction in manic and depressive symptoms as measured by the YMRS and HAM-D was seen. Using an intent to treat analysis with at least a 50%reduction in symptoms defined as improvement, 13 of 26 patients were considered responders. The overalll relapse rate for the study was significantly lower than the relapse rate during the previous year. At the 12 month endpoint the mean weight change was -.5 (+/- 1.1) kg. The most frequently reported side effect was somnolence (23.1%).
Publication
Vieta E, et al. Effects on weight and outcome of long-term olanzapine-topiramate combination treatment in bipolar disorder. J Clin Psychopharmacol. 2004;24:374-378.
Link
http://www.ncbi.nlm.nih.gov/pubmed/15232327
PI Name
Eduard Vieta
Degree
MD
Center
N/A
Institution
Fundacio Clinic Per A La Recerca Biomedica
Address
C/Villarroel, 170
City or Town
Barcelona
State or Province
N/A
Zip or Postal Code
8025
Country
Spain
Email Address
evieta@clinic.ub.es