Anti-psychotic Medication (Stable Dose) Weight Loss Study

Obesity Clinical Trial

Official title:

Surveillance Study of Weight Response and Body Composition in Subjects Taking a Stable Dose of Risperdal, Seroquel, and/or Zyprexa for Greater Than 3 Months in Combination With 500 mg IHBG-10 TID

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01272765
• Other study ID #: ARI-1320-IHBG10
• Status: Withdrawn
• Phase: Phase 2
• First received: January 6, 2011
• Last updated: May 31, 2012
• Start date: March 2012
• Est. completion date: January 2013

Study information

• Verified date: May 2012
• Source: Avera McKennan Hospital & University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• Placebo
Placebo

Dietary Supplement:
• IHBG-10
500 mg IHBG-10

Locations

Country	Name	City	State
United States	Avera Research Institute	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Avera McKennan Hospital & University Health Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight		12 weeks	No
Secondary	Body composition		12 weeks	No