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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH077117-01A2 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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).
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.
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| Measure | Description | Time Frame |
|---|---|---|
| ghrelin area under the curve | baseline, 2 and 4 months | |
| PYY area under the curve | baseline, 2 and 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| glucose area under the curve | baseline, 2 and 4 months | |
| insulin area under the curve | baseline, 2 and 4 months | |
| body composition |
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Inclusion Criteria:
Exclusion Criteria:
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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)
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| Name | Affiliation | Role |
|---|---|---|
| Kimberly A Brownley, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18255275 | Background | Graham KA, Cho H, Brownley KA, Harp JB. Early treatment-related changes in diabetes and cardiovascular disease risk markers in first episode psychosis subjects. Schizophr Res. 2008 Apr;101(1-3):287-94. doi: 10.1016/j.schres.2007.12.476. Epub 2008 Feb 5. | |
| 15625209 | Background | Graham KA, Perkins DO, Edwards LJ, Barrier RC Jr, Lieberman JA, Harp JB. Effect of olanzapine on body composition and energy expenditure in adults with first-episode psychosis. Am J Psychiatry. 2005 Jan;162(1):118-23. doi: 10.1176/appi.ajp.162.1.118. |
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| D015430 | Weight Gain |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
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whole blood, serum, plasma
| baseline, 2 and 4 months |
| subjective appetite ratings | baseline, 2 and 4 months |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |