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 @ 10:04 PM
Ignite Modification Date:
2025-12-24 @ 10:04 PM
NCT ID:
NCT04825535
Eligibility Criteria:
Inclusion Criteria:
* Beck Depression Inventory-II of at least mild severity (BDI-II score ≥ 14) with no upper severity limit;
* Psychiatrist diagnosis of Major Depression Disorder;
* Mini-International Neuropsychiatric Interview (MINI)-confirmed diagnosis of Major Depression Disorder;
* fluent in English.
Exclusion Criteria:
* individuals currently receiving weekly structured psychotherapy;
* individuals who meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria for severe alcohol/substance use disorder (in the past 3 months), borderline personality disorder, schizophrenia or any other primary psychotic disorder, bipolar disorder or obsessive-compulsive disorder;
* individuals who manifest clinically significant suicidal ideation defined as imminent intent or attempted suicide (in the past 6 months);
* individuals who are judged to have treatment resistant depression (TRD), as defined by failure in at least two trials of antidepressant medications and/or a course of psychotherapy during the current depressive episode
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT04825535
Study Brief:
Protocol Section:
NCT04825535