Grant ID

11T-014

Illness

bipolar

Primary Drug/Intervention

valnoctamide

Primary Dosage

1000 mg/d or 1500 mg/d

Secondary Drug Intervention

risperidone

Secondary Dosage

4 mg/d or 6 mg/d

Other Drug/Intervention

N/A

Other Dosage

N/A

Status

Terminated

Investigator

Weiser

Sample Size

323

Duration of Study Period for Each Subject

3 weeks

Outcome Measurements

N/A

Results

One hundred and seventy-three patients were randomized to monotherapy of valnoctamide, risperidone, or placebo for three weeks, in order to test the safety and efficacy of valnoctamide for the treatment of bipolar disorder. An interim analysis of the change in Young Mania Rating Scale (YMRS) from baseline to week 3 showed no significant improvement in the valnoctamide group compared to risperidone or placebo. Dropout rates were higher in the valnoctamide group compared to the other study groups. The study was terminated after the interim analysis due to lack of efficacy and high dropout rates.

Publication

N/A

Link

N/A

PI Name

Mark Weiser

Degree

MD

Center

Sheba Medical Center

Institution

Tel Aviv University

Address

City or Town

N/A

State or Province

N/A

Zip or Postal Code

N/A

Country

Israel

Email Address

mweiser@netvision.net.il