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 @ 12:01 PM
Ignite Modification Date:
2025-12-24 @ 12:01 PM
NCT ID:
NCT03923361
Eligibility Criteria:
Inclusion Criteria:
* Age 18-55
* Diagnosis of major depressive disorder or bipolar disorder
* Current moderate-to-severe depressive episode
* Episode duration more than 2 months and less than 5 years
* Failure of at least 2 adequate antidepressant medication trials within the past 2 years
* Body mass index \< 40
* 16-item Quick Inventory of Depressive Symptomatology, self-rated \> 10
Exclusion Criteria:
* Contraindication to propofol or midazolam
* Daily use of benzodiazepine, opioid, ACE inhibitor, or ARB medication
* Symptomatic coronary artery disease or heart failure
* Poorly controlled hypertension or diabetes
* Abnormal kidney or liver function
* Pregnant or breast feeding
* Traumatic brain injury or significant neurologic signs (past year)
* Substance use disorder (past year)
* Obsessive compulsive disorder (current)
* Post-traumatic stress disorder (current)
* Schizophrenia-spectrum disorder (lifetime)
* Neurocognitive disorder (current)
* Personality disorder as a current focus of treatment
* ECT within the past 3 months
* Inappropriate for ECT, or poor response to ECT within the past 5 years
* Incompetent to provide consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT03923361
Study Brief:
Protocol Section:
NCT03923361