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 @ 2:55 PM
Ignite Modification Date:
2025-12-24 @ 2:55 PM
NCT ID:
NCT05616559
Eligibility Criteria:
Inclusion Criteria:
* Age between 18 and 65 years
* Fulfilment of International Classification of Diseases version 10 diagnostic criteria for a primary depressive episode (i.e., not secondary to known organic or other psychiatric disorder).
* Referral to a treatment package for single-episode depression.
Exclusion Criteria:
* Psychosis or psychotic symptoms
* History of severe head trauma
* Somatic disease associated with morphological brain changes (e.g., brain tumour)
* Insufficient Danish language skills to complete questionnaires and cognitive testing
Additional exclusion criteria for Cohort II:
* Severe somatic disease
* Contraindications for MRI (e.g., metal implants, claustrophobia or back problems)
Additional exclusion criteria for Cohort III:
* Severe somatic disease
* Contraindications for MRI
* Exposure to radioactivity \>10 mSv within the last year
* Pregnancy or breastfeeding
* Use of psychotropic drugs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05616559
Study Brief:
Protocol Section:
NCT05616559