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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