Effect of Antipsychotics on Appetite Regulation (ADAPT)
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Purpose
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).
| Condition |
|---|
|
Psychotic Disorders |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Effect of Weight-increasing Psychotropic Medications on Appetite Regulation |
- ghrelin area under the curve [ Time Frame: baseline, 2 and 4 months ] [ Designated as safety issue: No ]
- PYY area under the curve [ Time Frame: baseline, 2 and 4 months ] [ Designated as safety issue: No ]
- glucose area under the curve [ Time Frame: baseline, 2 and 4 months ] [ Designated as safety issue: No ]
- insulin area under the curve [ Time Frame: baseline, 2 and 4 months ] [ Designated as safety issue: No ]
- body composition [ Time Frame: baseline, 2 and 4 months ] [ Designated as safety issue: No ]
- subjective appetite ratings [ Time Frame: baseline, 2 and 4 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
whole blood, serum, plasma
| Estimated Enrollment: | 45 |
| Study Start Date: | August 2007 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
patients ages 18 to 40 years of age who are early in treatment (i.e., started treatment in the past month) with 1 of 4 antipsychotic medications (olanzapine, risperidone, ziprasidone, aripiprazole)
Inclusion Criteria:
- 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 Criteria:
- 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.
Contacts and Locations| United States, North Carolina | |
| University of North Carolina at Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599 | |
| Principal Investigator: | Kimberly A Brownley, PhD | University of North Carolina, Chapel Hill |
More Information
Publications:
| Responsible Party: | Kimberly Brownley, Assistant Professor, University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT00903916 History of Changes |
| Other Study ID Numbers: | 3024-04003, 1R01MH077117-01A2 |
| Study First Received: | May 17, 2009 |
| Last Updated: | April 2, 2012 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Keywords provided by University of North Carolina, Chapel Hill:
|
antipsychotic ghrelin PYY appetite weight gain |
Additional relevant MeSH terms:
|
Psychotic Disorders Mental Disorders Schizophrenia and Disorders with Psychotic Features Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 21, 2013