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 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT04448327
Eligibility Criteria:
Inclusion Criteria:
* Current or past diagnosis of recurrent Major Depressive Disorder
Exclusion Criteria:
* History of neuroleptic use
* Any psychiatric disorder involving a history of psychosis (e.g. schizophrenia, bipolar I disorder)
* Active suicidal ideation with intent and/or plan or history of a suicide attempt within the last year
* Moderate or severe substance use disorder within the past 12 months
* Diagnosis of significant cardiovascular or cerebrovascular disease (e.g. congestive heart failure, stroke, cardiac conduction disorders, history of asystole or non-sustained ventricular tachycardia)
* Diseases affecting the CNS (e.g. MS, epilepsy, neurodegenerative diseases, etc.)
* Traumatic brain injury with cognitive sequelae
* MRI or tVNS contraindications (e.g. claustrophobia, metallic implants or devices)
* Pregnancy (uncommon, given the age of this cohort is 50+ years) due to unknown health risks for the fetus
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
65 Years
Study:
NCT04448327
Study Brief:
Protocol Section:
NCT04448327