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 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 12:01 AM
NCT ID:
NCT04944758
Eligibility Criteria:
Inclusion Criteria:
* \[1\] Outpatients 19 to 65 years of age;
* \[2\] Diagnostic and Statistical Manual (DSM)-5 criteria for major depressive disorder (MDD) past or recurrent episode as determined by the Mini International Neuropsychiatric Interview;
* \[3\] taking an antidepressant for no more than six months;
* \[4\] participant desire to discontinue antidepressant treatment because of adverse effects or other reasons;
* \[5\] total score ≤10 on the clinician-rated Montgomery-Asberg Depression Rating Scale \[MADRS\];
* \[6\] Willing and able to complete self-report and online assessments including sufficient fluency in English.
Exclusion Criteria:
* \[1\] Any psychiatric diagnosis other than MDD that is considered the primary diagnosis, including Bipolar I or Bipolar-II (lifetime);
* \[2\] MDD with psychotic features (lifetime);
* \[3\] significant personality disorder diagnosis \[e.g., borderline, antisocial\];
* \[4\] High suicidal risk, defined by clinician judgment;
* \[5\] History of drug or alcohol abuse, with a severity of at least moderate or severe within 6 months before screening;
* \[6\] Significant neurological disorders, head trauma, or other unstable medical conditions;
* \[7\] regular use of psychotropic medication other than an antidepressant or benzodiazepines (e.g., antipsychotics, mood stabilizers);
* \[8\] history of severe withdrawal effects with antidepressant discontinuation;
* \[9\] retinal disease or other eye condition preventing use of bright light therapy;
* \[10\] use of photosensitizing medication within 1 week of baseline visit.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
65 Years
Study:
NCT04944758
Study Brief:
Protocol Section:
NCT04944758