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 @ 3:43 AM
Ignite Modification Date:
2025-12-25 @ 3:43 AM
NCT ID:
NCT02858102
Eligibility Criteria:
Inclusion Criteria:
* Meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for depression, bipolar disorder or psychosis (at least 5 years of diagnosis).
* Meet criteria for metabolic syndrome (NCEP-ATP III 2003).
* Capable of providing signed and dated written informed consent in accordance with Good Clinical Practice (GCP) and the local legislation.
* Women of child-bearing potential must be ready and able to use highly effective methods of birth control.
Exclusion Criteria:
* Dependence or severe alcohol consumers (\>300 g/week).
* Co-infection with Hepatitis B, C or HIV.
* Cirrhosis diagnosed or presence of other hepatic comorbidities.
* Patients participating in a physical intervention program at least 6 months before inclusion.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
50 Years
Study:
NCT02858102
Study Brief:
Protocol Section:
NCT02858102