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

NCT01222793 | Completed

• 2 other identifiers: 99991046010-DA-N460
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Schizophrenia; Obesity

Keywords

High Weight Gain Liability (HWLA); Antipsychotic; Obesity; Low Weight Gain; Schizophrenia; Food Craving

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All participants must:
• be between age 18 and 45.
• have a BMI between 25 or above.
• Participants in the antipsychotic-medication groups must:
• \. meet DSM-IV criteria for schizophrenia or schizoaffective disorder, and have been stabilized on an antipsychotic medication for the past 3 months. Antipsychotics include olanzapine, clozapine, aripiprazole, ziprasidone, and first-generation antipsychotics (mid to high potency). Polypharmacy is allowed as long as both medications fit into the same grouping (HWGL or LWGL).
• Healthy controls must:
• \. have no DSM IV Axis I disorder (Schizophrenia or schizoaffective disorder, Depression, Bipolar Disorder) based on a SCID interview.

You may not qualify if:

• Participants will be excluded if they:
• meet DSM-IV criteria for a past and/or current eating disorder via the SCID, or if they have a past medical history of an eating disorder, received treatment/counseling for an eating disorder and/or required hospitalization for an eating disorder. (If an otherwise undiagnosed eating disorder is detected during screening, referral to treatment will be provided.)
• are taking risperidone, quetiapine, paliperidone, iloperidone, or low-potency first-generation antipsychotics (see Appendix A for complete list of excluded medications).
• are taking weight-loss medications, whether over-the-counter (i.e. Hydroxycut, Stacker products, Metabo-Plus, CortiSlim), or prescribed, including appetite suppressants (Didrex, Tenuate, Sanorex, Mazanor, Adipex-P, Meridia, and Phentermine) and fat-absorption inhibitors (Xenical).
• are currently enrolled in a nutrition-based weight-loss program (i.e. Weight Watchers, Jenny Craig, Nutri-System).
• have undergone weight-loss surgery (i.e. banding, gastric bypass surgery, sleeve gastrectomy, liposuction).
• have Cushing's syndrome, polycystic-ovary syndrome, hyperthyroidism, hypothyroidism, or a DSM-IV diagnosis of depression.
• have Type I or Type II diabetes, defined as a fasting blood glucose level of greater than or equal to 99.
• have cognitive impairment severe enough to preclude informed consent or valid responses on questionnaires. This is defined an as a score of less than 10 on the Evaluation to Sign Consent (ESC) and judged by the treating clinician. Participants obtaining a 10 on the ESC are re-briefed on the item that they missed, and are asked the question again until they get it correct to ensure their understanding.
• have a medical illness that, in the view of the investigators, would compromise participation.
• have dietary restrictions or food allergies that, in the view of the investigators, would compromise participation.
• are pregnant (as this might alter appetite or cravings).
• have begun or stopped smoking in the previous 3 months
• Also, participants will be excluded from the control group if they:
• are taking antipsychotics, antidepressants or mood stabilizers.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (1)

University of Maryland, Baltimore

Baltimore, Maryland, 21201-1595, United States

Location

Related Publications (3)

• Addington D, Addington J, Maticka-Tyndale E. Assessing depression in schizophrenia: the Calgary Depression Scale. Br J Psychiatry Suppl. 1993 Dec;(22):39-44.

  PMID: 8110442 BACKGROUND

• Andreasen NC. Negative symptoms in schizophrenia. Definition and reliability. Arch Gen Psychiatry. 1982 Jul;39(7):784-8. doi: 10.1001/archpsyc.1982.04290070020005.

  PMID: 7165477 BACKGROUND

• Baptista T, De Mendoza S, Beaulieu S, Bermudez A, Martinez M. The metabolic syndrome during atypical antipsychotic drug treatment: mechanisms and management. Metab Syndr Relat Disord. 2004 Fall;2(4):290-307. doi: 10.1089/met.2004.2.290.

  PMID: 18370698 BACKGROUND

MeSH Terms

Conditions

Schizophrenia; Obesity; Weight Gain

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Carol Myers, Ph.D.

  National Institute on Drug Abuse (NIDA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 15, 2010
• First Posted: October 18, 2010
• Study Start: September 26, 2010
• Study Completion: May 3, 2012
• Last Updated: July 2, 2017

Record last verified: 2012-05-03

Locations

US (1)