Effect of Antipsychotics on Appetite Regulation

NCT00903916 | Completed

• 2 other identifiers: 3024-040031R01MH077117-01A2
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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).

Conditions

Psychotic Disorders

Keywords

antipsychotic; ghrelin; PYY; appetite; weight gain

Outcome Measures

Primary Outcomes (2)

• ghrelin area under the curve

  baseline, 2 and 4 months

• PYY area under the curve

  baseline, 2 and 4 months

Secondary Outcomes (4)

• glucose area under the curve

  baseline, 2 and 4 months

• insulin area under the curve

  baseline, 2 and 4 months

• body composition

  baseline, 2 and 4 months

• subjective appetite ratings

  baseline, 2 and 4 months

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related 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.

  PMID: 18255275 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.

  PMID: 15625209 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, plasma

MeSH Terms

Conditions

Psychotic Disorders; Weight Gain

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kimberly A Brownley, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 17, 2009
• First Posted: May 19, 2009
• Study Start: August 1, 2007
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: April 3, 2012

Record last verified: 2012-04

Locations

US (1)