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Trial record 39 of 401 for:    PYY

Effect of Antipsychotics on Appetite Regulation (ADAPT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00903916
Recruitment Status : Completed
First Posted : May 19, 2009
Last Update Posted : April 3, 2012
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Kimberly Brownley, University of North Carolina, Chapel Hill

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 antipsychotic medications (olanzapine, risperidone, ziprasidone, aripiprazole).

Condition or disease
Psychotic Disorders

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.

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Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effect of Weight-increasing Psychotropic Medications on Appetite Regulation
Study Start Date : August 2007
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. ghrelin area under the curve [ Time Frame: baseline, 2 and 4 months ]
  2. PYY area under the curve [ Time Frame: baseline, 2 and 4 months ]

Secondary Outcome Measures :
  1. glucose area under the curve [ Time Frame: baseline, 2 and 4 months ]
  2. insulin area under the curve [ Time Frame: baseline, 2 and 4 months ]
  3. body composition [ Time Frame: baseline, 2 and 4 months ]
  4. subjective appetite ratings [ Time Frame: baseline, 2 and 4 months ]

Biospecimen Retention:   Samples With DNA
whole blood, serum, plasma

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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:

  1. Meets DSM IV criteria for a psychotic disorder (schizophrenia, schizophreniform, brief psychotic disorder, schizoaffective disorder), bipolar disorder, or major depression with psychotic features;
  2. "Drug naïve" prior to most recent psychiatric diagnosis;
  3. Currently prescribed one of four atypical antipsychotic medications: olanzapine, risperidone, ziprasidone, or aripiprazole;
  4. Between the ages of 18 and 40, any race and either gender;
  5. Not obese (BMI < 30 kg/m2) (fasting and postprandial ghrelin levels are altered in obesity);
  6. Has negative histories for cardiovascular, metabolic, and endocrine disorders at screening;
  7. Is willing and able to eat animal-derived foods; and
  8. Is not exercising 3 or more times per week.

Exclusion Criteria:

  1. Use of medications to treat metabolic and endocrine abnormalities, corticosteroids, over-the-counter appetite suppressants that contain phentermine or Sibutramine;
  2. Active involvement with a weight loss program (i.e., Weight Watchers);
  3. Serious or unstable medical illness which requires ongoing treatment with medication (this does not include hypertension);
  4. Anemia;
  5. At serious suicidal risk;
  6. Current substance abuse or dependence;
  7. For female subjects, pregnancy or nursing (because pregnancy may influence appetite and because the body composition procedure involves low level X-ray exposure).
  8. Known history of mental retardation or dementia.
  9. Children and adolescents under age 18 will be excluded owing to the inherent confounding effects of normal growth on body weight and appetite.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00903916

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United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute of Mental Health (NIMH)
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Principal Investigator: Kimberly A Brownley, PhD University of North Carolina, Chapel Hill

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Responsible Party: Kimberly Brownley, Assistant Professor, University of North Carolina, Chapel Hill Identifier: NCT00903916     History of Changes
Other Study ID Numbers: 3024-04003
1R01MH077117-01A2 ( U.S. NIH Grant/Contract )
First Posted: May 19, 2009    Key Record Dates
Last Update Posted: April 3, 2012
Last Verified: April 2012

Keywords provided by Kimberly Brownley, University of North Carolina, Chapel Hill:
weight gain

Additional relevant MeSH terms:
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Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs