Effect of Antipsychotics on Appetite Regulation
Completed
Conditions studied: Psychotic Disorders
In brief
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).
Key facts
- Study ID
- NCT00903916
- Run by
- University of North Carolina, Chapel Hill
- People needed
- 45
- Starts
- 2007-08-01
- Expected to finish
- 2012-03-01
- Last updated by the study team
- 2012-04-03
Who can join
Age: 18 and older, up to 40. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
Full record on ClinicalTrials.gov
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