Effect of Antipsychotics on Appetite Regulation

Psychotic Disorders Clinical Trial

— ADAPT  

Official title:

Effect of Weight-increasing Psychotropic Medications on Appetite Regulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00903916
• Other study ID #: 3024-04003
• Secondary ID: 1R01MH077117-01A
• Status: Completed
• Phase: N/A
• First received: May 17, 2009
• Last updated: April 2, 2012
• Start date: August 2007
• Est. completion date: March 2012

Study information

• Verified date: April 2012
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ghrelin area under the curve		baseline, 2 and 4 months	No
Primary	PYY area under the curve		baseline, 2 and 4 months	No
Secondary	glucose area under the curve		baseline, 2 and 4 months	No
Secondary	insulin area under the curve		baseline, 2 and 4 months	No
Secondary	body composition		baseline, 2 and 4 months	No
Secondary	subjective appetite ratings		baseline, 2 and 4 months	No