Anti-psychotic Medication (Stable Dose) Weight Loss Study

Avera McKennan Hospital & University Health Center

Status and phase: Withdrawn; Phase 2

Conditions: Obesity

Treatments: Other: Placebo; Dietary Supplement: IHBG-10

Study type: Interventional

Funder types: Other

Identifiers

NCT01272765

ARI-1320-IHBG10

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 4 patient groups, including a placebo group

Control Group

Placebo Comparator group

Treatment:

Other: Placebo

Risperdal Group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: IHBG-10

Seroquel Group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: IHBG-10

Zyprexa Group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: IHBG-10