Anti-psychotic Medication (Stable Dose) Weight Loss Study

Phase 2

Withdrawn

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

• Registration Number: NCT01272765
• 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 been taking a stable dose of certain anti-psychotic medications for longer than three months.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2011-01-06
• Study First Submitted QC: 2011-01-06
• Study First Posted: 2011-01-10
• Study Start: 2012-03
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-31
• Last Update Posted: 2012-06-01
• Primary Completion: 2013-01
• Study Completion: 2013-01

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• Status: WITHDRAWN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
• Currently on a stable dose of Risperdal (Risperidone), Seroquel (Quetiapine) and/or Zyprexa (Olanzapine) for at least three 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
Control Group	Placebo	-
Risperdal Group	IHBG-10	Subjects who are on a stable dose of Ripserdal and taking 500 mg IHBG-10 15 minutes prior to the three main meals of the day.
Seroquel Group	IHBG-10	Subjects who are on a stable dose of Seroquel and taking 500 mg of IHBG-10 15 minutes before the three main meals of the day.
Zyprexa Group	IHBG-10	Subjects who are on a stable dose of Zyprexa and taking 500 mg of IHBG-10 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