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Effects of Antipsychotics on Eating and Food Craving in People With Schizophrenia

NCT01222793 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2017-07-02

No results posted yet for this study

Summary

Background:

\- Although second-generation antipsychotic medications have fewer serious side effects and complications than first-generation ones, they are strongly associated with weight gain for reasons that are as yet unknown. Comparing the effects of second-generation antipsychotics with a high weight-gain liability (HWGL) low weight-gain liability (LWGL) antipsychotics may provide more information on which medications are best suited for different individuals. Researchers are interested in studying how people taking various antipsychotics compare with controls in regard to food craving and eating behavior. This knowledge should help to guide practitioners when advising patients about the weight-gain effects of these medications.

Objectives:

\- To examine eating behavior and food craving in patients with schizophrenia who are taking HWGL antipsychotics compared with those taking LWGL antipsychotics and with healthy controls taking no antipsychotics.

Eligibility:

* Individuals between 18 and 45 years of age who have been diagnosed with schizophrenia or a related disorder, have a body mass index between 25 and 29.9, and have never had an eating disorder.
* Healthy individuals between 18 and 45 years of age who have a body mass index between 25 and 29.9 and have never had an eating disorder.

Design:

* This study involves an initial screening visit and four study visits.
* Participants will be screened with a medical history and physical examination, as well as questionnaires about stress levels, food cravings, smoking, exercise, and eating habits; a taste test; and saliva collection (to measure stress hormones).
* Visit 2: Participants will have an optional overnight stay, and will provide blood samples before having a breakfast beverage and answering questions about tiredness, anxiety, hunger, and alertness during a 1.5 hour session.

Visit 3: Participants will have an optional overnight stay and a light breakfast, followed by blood draws and questions about hunger and food cravings.

Visit 4: Participants will have an optional overnight stay, followed by questions about food preference. Participants will not be allowed to eat until mid-morning of the next day.

Visit 5: Participants will eat normally before arriving at the research site, and will have tests to measure food craving and questionnaires about mood and feelings.

Conditions

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    lead NIH

Principal Investigators

  • Carol Myers, Ph.D. · National Institute on Drug Abuse (NIDA)

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-09-26
Completion
2012-05-03

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01222793 on ClinicalTrials.gov