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 @ 6:28 PM
Ignite Modification Date:
2025-12-24 @ 6:28 PM
NCT ID:
NCT01487668
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of serious mental illness (schizophrenia, bipolar disorder, other psychosis, major depressive disorder, or other recurrent depression or affective disorder)
* Have at least one of the following risk factors for CVD (cardiovascular disease):
* Body mass index (BMI) \>28 or waist circumference of \>35 (women) or \>40 (men) inches OR
* Self-reported diagnosis of hypertension ("high blood pressure"), dyslipidemia ("high cholesterol") or diabetes or high blood sugar OR
* Documentation in the medical record of a diagnosis of or treatment for hypertension (defined as documented diagnosis or blood pressure of \>140/90 on 2 occasions or prescription for an antihypertensive medication), dyslipidemia (documented diagnosis or LDL\>160 or prescription for a lipid-lowering medication) or diabetes mellitus (documented diagnosis or HbA1C \>7% or current prescription for oral hypoglycemic therapy)
Exclusion Criteria:
* Have unresolved substance intoxication or withdrawal, such as appearing to be intoxicated (e.g., incoherent, slurred speech), or experiencing withdrawal symptoms from substance abuse at the time of enrollment.
* Are unwilling or unable to provide informed consent or comply with study requirements at the time of enrollment (e.g., unable to complete forms or attend sessions due to substantial functional limitations).
* Active suicidal ideation at time of enrollment (focused interventions are more appropriate for this group)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT01487668
Study Brief:
Protocol Section:
NCT01487668