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 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT00323193
Eligibility Criteria:
Inclusion Criteria:
* DSM- IV diagnosis of schizophrenia spectrum disorders OR a DSM-IV diagnosis of other severe mental disorder including bipolar disorder, major depression, or severe anxiety disorder;
* Age between 18-64;
* No psychiatric hospitalization in 3-month period prior to enrollment;
* Community residency within 30 miles of either VA facility;
* A BMI of 25 or higher;
* Voluntary consent after receiving full information about the study;
* English speaking;
* Veteran of the armed forces
Exclusion Criteria:
* Active cancer other than non-melanoma skin cancer
* end stage chronic obstructive pulmonary disease
* end stage congestive heart failure
* end-stage neurological disorder
* problematic substance abuse as defined by provider
* end stage renal disease
* moderate to severe cognitive impairment (dementia, post-stroke)
* HIV positive with a CD4 count less than or equal to 350 within the last 6 months
* anorexia
* current pregnancy, currently nursing or planning to become pregnant in the next 6 months
* those living in long-term care facilities
* use in past 3 months of prescription pharmacological agents for weight loss
* no chart documented VA delivered medical primary care or general somatic care visit within the last 18 months
* most recent chart documented hematocrit level obtained within last six months is at or below 30%
* most recent chart documented creatinine level obtained within the last six months that is at or above 2.5
* most recent chart documented liver function tests obtained within the last six months exceeds twice the normal value for ALT, AST test in the Baltimore VA laboratory
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00323193
Study Brief:
Protocol Section:
NCT00323193