Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2025-12-25 @ 1:12 AM
NCT ID:
NCT01222793
Eligibility Criteria:
* 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01222793
Study Brief:
Protocol Section:
NCT01222793