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 @ 7:40 PM
Ignite Modification Date:
2025-12-24 @ 7:40 PM
NCT ID:
NCT04575103
Eligibility Criteria:
Inclusion Criteria:
* Patients with SMI defined according to ICD-10 as:
* F20.0-F20.9 schizophrenia
* F22.0-F22.9 paranoid psychosis
* F25.0-F25.9 schizo-affective psychosis
* F28 other non-organic psychosis
* F29 non-organic psychosis unspecified
* F31.0-F31.9 bipolar affective disorder.
* Patients treated with or initiating antipsychotics with ≥ 0.5 daily defined dosage
* \>18 years old and \<50 years.
Exclusion Criteria:
* Patients not capable to understand the aim of the study as judged by investigator.
* Current in treatment with methadone.
* Left ventricular hypertrophy (echocardiographic septal thickness ≥1.3 cm for women and ≥1.4 cm for men, or LVM/BSA ≥109 g/m2 for women or ≥132 g/m2 for men).
* Heart failure (echocardiographic LVEF \<35%).
* Ischemic heart disease (patient reported coronary bypass grafting or percutaneous coronary intervention.
* Congenital cardiovascular disease (patient reported).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT04575103
Study Brief:
Protocol Section:
NCT04575103