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:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2025-12-24 @ 10:29 PM
NCT ID:
NCT02090335
Eligibility Criteria:
Inclusion Criteria:
* age 21 or older
* serious mental illness defined by an axis I diagnosis of major depression, bipolar disorder, schizoaffective disorder, or schizophrenia
* persistent impairment in multiple areas of functioning (e.g., work, school, self-care)
* body mass index (BMI) greater than 25
* able and willing to provide informed consent
* on stable pharmacological treatment (same psychiatric medications over prior 2 months)
Exclusion Criteria:
* residing in nursing home or other institution
* diagnosis of dementia or significant cognitive impairment (MMSE\<24)
* unable to walk one city block
* pregnant or planning to become pregnant within the next 18 months
* unable to speak English
* terminal illness with life expectancy\<1 year
* current diagnosis of an active substance dependence disorder
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT02090335
Study Brief:
Protocol Section:
NCT02090335