Anti-psychotic Medication (New Use) Weight Loss Study

Phase 2

Withdrawn

• Conditions: Obesity
• Interventions: Dietary Supplement: IHBG-10; Dietary Supplement: Placebo

• Registration Number: NCT01272752
• Lead Sponsor: Avera McKennan Hospital & University Health Center

Brief 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).

Detailed 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 Timeline

• Study First Submitted: 2011-01-06
• Study First Submitted QC: 2011-01-06
• Study First Posted: 2011-01-10
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-31
• Last Update Posted: 2012-06-01
• Study Start: 2013-04
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Men and women, age 18 and older
• Agree to keep diet, exercise and all current health habits stable during participation in the study
• Have been taking Risperdal (Risperidone), Seroquel (Quetiapine), or Zyprexa (Olanzapine) for less than 3 months

Exclusion Criteria

• Current active acute psychotic episode
• Women who are pregnant, breastfeeding or planning to become pregnant
• Prior bariatric surgery
• Use of prescription or over-the-counter appetite suppressants, herbal products or other medications for weight loss within the past month
• Obesity as a result of a clinically-diagnosed endocrine problem

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group	IHBG-10	Subjects will take 500 mg IHBG-10 15 minutes prior to the three main meals of the day.
Control Group	Placebo	Subjects will take a placebo 15 minutes prior to the three main meals of the day.

Primary Outcome Measures

Name	Time	Method
Weight	12 weeks

Secondary Outcome Measures

Name	Time	Method
Body composition	12 weeks

Trial Locations

Locations (1)

Avera Research Institute; 🇺🇸 Sioux Falls, South Dakota, United States