Status:
COMPLETED
Effect of Antipsychotics on Appetite Regulation
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Psychotic Disorders
Eligibility:
All Genders
18-40 years
Brief 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 antip...
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 ...
Eligibility Criteria
Inclusion
- Meets DSM IV criteria for a psychotic disorder (schizophrenia, schizophreniform, brief psychotic disorder, schizoaffective disorder), bipolar disorder, or major depression with psychotic features;
- "Drug naïve" prior to most recent psychiatric diagnosis;
- Currently prescribed one of four atypical antipsychotic medications: olanzapine, risperidone, ziprasidone, or aripiprazole;
- Between the ages of 18 and 40, any race and either gender;
- Not obese (BMI \< 30 kg/m2) (fasting and postprandial ghrelin levels are altered in obesity);
- Has negative histories for cardiovascular, metabolic, and endocrine disorders at screening;
- Is willing and able to eat animal-derived foods; and
- Is not exercising 3 or more times per week.
Exclusion
- Use of medications to treat metabolic and endocrine abnormalities, corticosteroids, over-the-counter appetite suppressants that contain phentermine or Sibutramine;
- Active involvement with a weight loss program (i.e., Weight Watchers);
- Serious or unstable medical illness which requires ongoing treatment with medication (this does not include hypertension);
- Anemia;
- At serious suicidal risk;
- Current substance abuse or dependence;
- For female subjects, pregnancy or nursing (because pregnancy may influence appetite and because the body composition procedure involves low level X-ray exposure).
- Known history of mental retardation or dementia.
- Children and adolescents under age 18 will be excluded owing to the inherent confounding effects of normal growth on body weight and appetite.
Key Trial Info
Start Date :
August 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2012
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00903916
Start Date
August 1 2007
End Date
March 1 2012
Last Update
April 3 2012
Active Locations (1)
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1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599