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 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT06322420
Eligibility Criteria:
Inclusion Criteria:
1. Current major depressive episode according to the DSM-5 diagnostic criteria evaluated with the DIAMOND diagnostic interview, that is considered to be the primary diagnosis.
2. Sore of 14 or higher on Becks Depression Inventory-II (BDI-II) that measures severity of symptoms of depression past 2 weeks.
3. Participants are between 18 and 65 years of age at start of study.
4. Satisfactory understanding of the Icelandic language to complete measures in the study.
5. Completion of pre-treatment assessment that includes 2 visits to researchers and a 6-day ecological momentary assessment.
Exclusion Criteria:
1. Current or past manic or hypomanic episodes according to the DSM-5 diagnostic criteria evaluated with the DIAMOND diagnostic interview.
2. Current or past psychotic disorders according to the DSM-5 diagnostic criteria evaluated with the DIAMOND diagnostic interview.
3. Presence of substance abuse within the last 12 months according to the DSM-5 diagnostic criteria evaluated with the DIAMOND diagnostic interview.
4. Presence of active and serious suicidal thoughts or a suicidal attempt in the previous 2 months.
5. Unstable medical treatment for depression (type of drug and/or dosing) during past two months at pre-treatment assessment.
6. Recent psychotherapy within the past month at pre-treatment assessment or active psychotherapy during study participation.
7. Cognitive impairments or severe physical illness.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06322420
Study Brief:
Protocol Section:
NCT06322420