Anti-psychotic Medication (Stable Dose) Weight Loss Study
| Status: | Archived |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | March 2011 |
| End Date: | January 2012 |
Surveillance Study of Weight Response and Body Composition in Subjects Taking a Stable Dose of Risperdal, Seroquel, and/or Zyprexa for Greater Than 3 Months in Combination With 500 mg IHBG-10 TID
This is a pilot study to determine the safety and efficacy of an investigational product
(IHBG-10) on weight change and changes in body composition in subjects who have been taking
a stable dose of certain anti-psychotic medications for longer than three months.
A total of 80 subjects will be enrolled in this study: 20 subjects will be randomized to
receive placebo, and 60 will be randomized to receive the investigational product (20 who
are on a stable dose of Seroquel, 20 who are on a stable dose of Risperdal, and 20 who are
on a stable dose of Zyprexa). The investigational product or placebo will be taken 15
minutes prior to the three main meals of the day. Subjects will continue to take their
prescribed anti-psychotic medications. Participation in this study involves four study
visits.
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