Anti-psychotic Medication (New Use) Weight Loss Study
NCT01272752 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2012-06-01
Summary
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).
Conditions
Interventions
- DIETARY_SUPPLEMENT
-
IHBG-10
500 mg IHBG-10
- DIETARY_SUPPLEMENT
-
Placebo
Placebo taken 15 minutes prior to the three main meals of the day
Sponsors & Collaborators
-
Avera McKennan Hospital & University Health Center
lead OTHER
Principal Investigators
-
Timothy Soundy, MD · Avera McKennan Hospital & University Health Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-04-30
- Primary Completion
- 2013-12-31
- Completion
- 2013-12-31
Countries
- United States
Study Locations
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