Anti-psychotic Medication (Stable Dose) Weight Loss Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Obesity

Intervention / Treatment
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* Other: Placebo
* Dietary Supplement: IHBG-10


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Group<br> | Other: Placebo<br>* Placebo<br>* Other names: sugar pill;|
| Experimental: Risperdal Group<br>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. | Dietary Supplement: IHBG-10<br>* 500 mg IHBG-10<br>* Other names: IHBG10;|
| Experimental: Seroquel Group<br>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. | Dietary Supplement: IHBG-10<br>* 500 mg IHBG-10<br>* Other names: IHBG10;|
| Experimental: Zyprexa Group<br>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. | Dietary Supplement: IHBG-10<br>* 500 mg IHBG-10<br>* Other names: IHBG10;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, weight loss, weight management, anti-psychotic medication, Zyprexa, Seroquel, Risperdal