Back to Awarded Treatment Trials
Awarded Trial: 07TGF-1162
Grant ID
07TGF-1162
Illness
Bipolar manic or mixed
Primary Drug/Intervention
Zonisamide
Primary Dosage
100-300 mg/day
Secondary Drug Intervention
N/A
Secondary Dosage
N/A
Other Drug/Intervention
N/A
Other Dosage
N/A
Status
Completed
Investigator
Rosenthal
Sample Size
100
Duration of Study Period for Each Subject
16-17 weeks
Outcome Measurements
CGI, YMRS, MADRS, CGI-BP, Q-LES-Q
Results
One hundred and four (104) patients with BP I or II in a manic, hypomanic, or mixed state were randomized to zonisamide 300 mg for 6 weeks. There was a large placebo response. The groups did not significantly differ in outcome measure, and it is being written up as a negative study.
Publication
N/A
Link
N/A
PI Name
Norman Rosenthal
Degree
MD
Center
N/A
Institution
Capital Clinical Research Associates
Address
5515 Security Lane, Suite 525
City or Town
Rockville
State or Province
MD
Zip or Postal Code
20852
Country
USA
Email Address
norm.rosenthal@gmail.com