Effect of Antipsychotics on Appetite Regulation (ADAPT)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kimberly Brownley, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00903916
First received: May 17, 2009
Last updated: April 2, 2012
Last verified: April 2012
  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

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
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)

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00903916

Locations
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
Investigators
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:
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 22, 2014