Status:
COMPLETED
Effects of Antipsychotics on Eating and Food Craving in People With Schizophrenia
Lead Sponsor:
National Institute on Drug Abuse (NIDA)
Conditions:
Schizophrenia
Obesity
Eligibility:
All Genders
18-45 years
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 rea...
Detailed Description
Objective Some second-generation antipsychotics, such as olanzapine and clozapine, seem especially prone to induce metabolic complications and substantial increases in weight. The mechanisms of these...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 26 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 3 2012
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01222793
Start Date
September 26 2010
End Date
May 3 2012
Last Update
July 2 2017
Active Locations (1)
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1
University of Maryland, Baltimore
Baltimore, Maryland, United States, 21201-1595