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 @ 3:48 AM
Ignite Modification Date:
2025-12-25 @ 3:48 AM
NCT ID:
NCT05772702
Eligibility Criteria:
Inclusion Criteria:
* Ages 18-70 years
* Diagnostic and Statistical Manual, 5th Edition (DSM-5) diagnosis of MDD; unipolar, non-psychotic
* Hamilton Rating Depression Rating Scale (HRDS-17) score \>8
* Low suicide risk as determined by the Columbia-Suicide Severity Rating Scale (C-SSRS) triage form (no intent or plan)
* Capacity to understand all relevant risks and potential benefits of the study (informed consent)
Exclusion Criteria:
* DSM-5 diagnosis of severe alcohol use disorder (AUD) within the last 12 months.
* DSM-5 diagnosis of moderate to severe substance use disorder (excluding tobacco) within the last 12 months.
* Lifetime history of bipolar disorder, psychotic disorder, schizophrenia, autism
* Current use of benzodiazepines \> 20mg diazepam/d equivalent
* Antidepressant dose change within the last 2 weeks
* Initiated new antidepressant within the last 4 weeks
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05772702
Study Brief:
Protocol Section:
NCT05772702