Anti-psychotic Medication (New Use) Weight Loss Study

Avera McKennan Hospital & University Health Center

Status and phase

Withdrawn

Phase 2

Conditions

Obesity

Treatments

Dietary Supplement: IHBG-10

Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01272752

ARI-1310-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 just started taking (for less than three months) certain anti-psychotic medications (Risperdal, Seroquel, and/or Zyprexa).

Full description

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.

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
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