Obesity Clinical Trial
Official title:
Effects of Antipsychotics on Eating and Food Craving in People With Schizophrenia
Verified date | May 3, 2012 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | May 3, 2012 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility |
- INCLUSION CRITERIA: All participants must: - be between age 18 and 45. - have a BMI between 25 or above. Participants in the antipsychotic-medication groups must: 1. 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: 1. have no DSM IV Axis I disorder (Schizophrenia or schizoaffective disorder, Depression, Bipolar Disorder) based on a SCID interview. EXCLUSION CRITERIA: 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Maryland, Baltimore | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute on Drug Abuse (NIDA) |
United States,
Addington D, Addington J, Maticka-Tyndale E. Assessing depression in schizophrenia: the Calgary Depression Scale. Br J Psychiatry Suppl. 1993 Dec;(22):39-44. — View Citation
Andreasen NC. Negative symptoms in schizophrenia. Definition and reliability. Arch Gen Psychiatry. 1982 Jul;39(7):784-8. — View Citation
Baptista T, De Mendoza S, Beaulieu S, Bermúdez 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. — View Citation
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