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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Placebo Comparator |
| |
| Risperdal Group | Experimental | 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 | Experimental | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | Placebo |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Body composition | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward Zawada, MD | Avera McKennan Hospital & University Health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Avera Research Institute | Sioux Falls | South Dakota | 57105 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D002241 | Carbohydrates |
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| IHBG-10 |
| Dietary Supplement |
500 mg IHBG-10 |
|
|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |