Anti-psychotic Medication (Stable Dose) Weight Loss Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-01-31

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.

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control Group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

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.

Group Type EXPERIMENTAL

IHBG-10

Intervention Type DIETARY_SUPPLEMENT

500 mg IHBG-10

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.

Group Type EXPERIMENTAL

IHBG-10

Intervention Type DIETARY_SUPPLEMENT

500 mg IHBG-10

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.

Group Type EXPERIMENTAL

IHBG-10

Intervention Type DIETARY_SUPPLEMENT

500 mg IHBG-10

Interventions

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Placebo

Intervention Type OTHER

IHBG-10

500 mg IHBG-10

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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sugar pill IHBG10

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No