Anti-psychotic Medication (New Use) Weight Loss Study
| Status: | Archived |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | April 2011 |
| End Date: | December 2011 |
Surveillance Study of Weight Response and Body Composition in Subjects Who Are First-Time Users (Less Than 3 Months) of the Following Medications: Risperdal, Seroquel, and/or Zyprexa, 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 just started
taking (for less than three months) certain anti-psychotic medications (Risperdal, Seroquel,
and/or Zyprexa).
A total of 30 subjects will be enrolled in this study. They will be randomized in to one of
two groups. One group (of 20 subjects) will take 500 mg of the investigational product
(IHBG-10) 15 minutes prior to the three main meals of the day; subjects will continue to
take their prescribed anti-psychotic medications. The other group (of 10 subjects) will take
a placebo 15 minutes prior to the three main meals of the day; subjects will continue to
take their prescribed anti-psychotic medications. Subjects will take the investigational
product or placebo for 12 weeks. Participation in this study involves 4 study visits.
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