- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01272765
Anti-psychotic Medication (Stable Dose) Weight Loss Study
May 31, 2012 updated by: Avera McKennan Hospital & University Health Center
Surveillance Study of Weight Response and Body Composition in Subjects Taking a Stable Dose of Risperdal, Seroquel, and/or Zyprexa for Greater Than 3 Months 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 been taking a stable dose of certain anti-psychotic medications for longer than three months.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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 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
-
-
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
- 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 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
|
Placebo
Other Names:
|
Experimental: Risperdal Group
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.
|
500 mg IHBG-10
Other Names:
|
Experimental: Seroquel Group
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.
|
500 mg IHBG-10
Other Names:
|
Experimental: Zyprexa Group
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.
|
500 mg IHBG-10
Other Names:
|
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.
Investigators
- Principal Investigator: Edward Zawada, 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
March 1, 2012
Primary Completion (Anticipated)
January 1, 2013
Study Completion (Anticipated)
January 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
Additional Relevant MeSH Terms
Other Study ID Numbers
- ARI-1320-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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