Anti-psychotic Medication (New Use) Weight Loss Study

Obesity Clinical Trial

Official title:

Surveillance Study of Weight Response and Body Composition in Subjects Who Are First-Time Users (Less Than 3 Months) of the Following Medications: Risperdal, Seroquel, and/or Zyprexa, in Combination With 500 mg IHBG-10 TID

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01272752
• Other study ID #: ARI-1310-IHBG10
• Status: Withdrawn
• Phase: Phase 2
• First received: January 6, 2011
• Last updated: May 31, 2012
• Start date: April 2013
• Est. completion date: December 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 just started taking (for less than three months) certain anti-psychotic medications (Risperdal, Seroquel, and/or Zyprexa).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2013
• Est. primary completion date: December 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

• 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

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

Dietary Supplement:
• IHBG-10
500 mg IHBG-10
• Placebo
Placebo taken 15 minutes prior to the three main meals of the day

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

External Links

•   Avera Research Institute website