Anti-psychotic Medication (New Use) Weight Loss Study

May 31, 2012 updated by: Avera McKennan Hospital & University Health Center

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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Avera Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control Group
Subjects will take a placebo 15 minutes prior to the three main meals of the day.
Dietary supplement: Placebo
Placebo taken 15 minutes prior to the three main meals of the day
Other Names:
  • sugar pill
Experimental: Study Group
Subjects will take 500 mg IHBG-10 15 minutes prior to the three main meals of the day.
Dietary supplement: IHBG-10
500 mg IHBG-10
Other Names:
  • IHBG10

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Body composition
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Avera McKennan Hospital & University Health Center

Investigators

  • Principal Investigator: Timothy Soundy, MD, Avera McKennan Hospital & University Health Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

January 6, 2011

First Submitted That Met QC Criteria

January 6, 2011

First Posted (Estimate)

January 10, 2011

Study Record Updates

Last Update Posted (Estimate)

June 1, 2012

Last Update Submitted That Met QC Criteria

May 31, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARI-1310-IHBG10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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