SPDS 09052014 - page 218

Sensoril® - Clinical Study - Mental Cognition in Stable
Bipolar Patients – University of Pittsburgh
Study Design
: As per IND with US FDA
Double blind, randomized, parallel group, adjunctive treatment, 30
subjects in each group.
Sensoril® vs. Placebo, added to ongoing maintenance bipolar
medications
Dosage Regimen
250 mg first week, once a day, increased to 250 mg twice daily, for rest
of the study
Total Duration: 8 weeks
Funded by
NARSAD (NY based sponsor of studies in bipolar and schizophrenic
patients)
Accepted for publication in the Journal of
Clinical Psychiatry
23
CONFIDENTIAL
Sensoril® - Cognition Study - Demographics
Group 1 (n=30)
Group 2 (n=30)
Age (years)
Mean
SD
Mean
SD
46.9
10.38
45.93
10.40
Gender
Male
Female
Male
Female
13
17
10
20
Race
White
African
American
Other
White
African
American
Other
21
9
0
18
11
1
Education
High School
or Less
University Other
High School
or Less
University
Other
7
22
1
8
20
2
Marital Status
Single
Married
Divorced/Separated
13
6
10
13
7
10
24
CONFIDENTIA
L
1...,208,209,210,211,212,213,214,215,216,217 219,220,221,222,223,224,225,226,227,228,...277
Powered by FlippingBook