Anti-psychotic Medication (New Use) Weight Loss Study

NCT ID: NCT01272752

Last Updated: 2012-06-01

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WITHDRAWN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

2013-04-30

Study Completion Date

2013-12-31

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 just started taking (for less than three months) certain anti-psychotic medications (Risperdal, Seroquel, and/or Zyprexa).

Detailed Description

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A total of 30 subjects will be enrolled in this study. They will be randomized in to one of two groups. One group (of 20 subjects) will take 500 mg of the investigational product (IHBG-10) 15 minutes prior to the three main meals of the day; subjects will continue to take their prescribed anti-psychotic medications. The other group (of 10 subjects) will take a placebo 15 minutes prior to the three main meals of the day; subjects will continue to take their prescribed anti-psychotic medications. Subjects will take the investigational product or placebo for 12 weeks. Participation in this study involves 4 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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Study Group

Subjects will take 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

Control Group

Subjects will take a placebo 15 minutes prior to the three main meals of the day.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo taken 15 minutes prior to the three main meals of the day

Interventions

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IHBG-10

500 mg IHBG-10

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo taken 15 minutes prior to the three main meals of the day

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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IHBG10 sugar pill

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
* Have been taking Risperdal (Risperidone), Seroquel (Quetiapine), or Zyprexa (Olanzapine) for less than 3 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

Sponsors

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Avera McKennan Hospital & University Health Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Timothy Soundy, MD

Role: PRINCIPAL_INVESTIGATOR

Avera McKennan Hospital & University Health Center

Locations

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Avera Research Institute

Sioux Falls, South Dakota, United States

Site Status

Countries

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United States

Other Identifiers

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ARI-1310-IHBG10

Identifier Type: -

Identifier Source: org_study_id

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