Anti-psychotic Medication (New Use) Weight Loss Study

Obesity Clinical Trial

Official title: 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

Status Withdrawn

Clinical Trial 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).

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

• NCT number: NCT01272752
• Study type: Interventional
• Source: Avera McKennan Hospital & University Health Center
• Status: Withdrawn
• Phase: Phase 2
• Start date: April 2013
• Completion date: December 2013