Trials / Completed
CompletedNCT00903916
Effect of Antipsychotics on Appetite Regulation
Effect of Weight-increasing Psychotropic Medications on Appetite Regulation
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 45 (estimated)
- Sponsor
- University of North Carolina, Chapel Hill · Academic / Other
- Sex
- All
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate changes in appetite-regulating hormones, body composition (weight, body fat%), and hunger ratings in persons early in treatment with one of four atypical antipsychotic medications (olanzapine, risperidone, ziprasidone, aripiprazole).
Detailed description
Severe weight gain and glucose dysregulation are serious problems in patients treated with second-generation ('atypical') antipsychotics (SGA). These side effects frequently interfere with medication compliance and necessitate discontinuation of treatment. Although the causal mechanisms for weight and glucose dysregulation are not well understood, one promising area of investigation targets SGA-induced disturbances in appetite and in appetite-regulating hormones. Findings from our group (and others) demonstrate SGA treatment-related increases in fasting levels of the appetite-stimulating hormone, ghrelin, as well as increases in self-report hunger. This novel study will examine prospective changes in ghrelin and in the 'satiety-signaling' peptide YY (PYY) as measured before and after participants consume a standard mixed-macronutrient meal. Data are obtained at baseline (within 4 weeks of beginning medication), and again 2 months and 4 months later.
Conditions
Timeline
- Start date
- 2007-08-01
- Primary completion
- 2012-03-01
- Completion
- 2012-03-01
- First posted
- 2009-05-19
- Last updated
- 2012-04-03
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00903916. Inclusion in this directory is not an endorsement.