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 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT02994433
Eligibility Criteria:
Inclusion Criteria:
* Adults 18-65 years of age
* Right-handed
* Controls: Not meet The Fourth Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for major depressive disorder (MDD) by scoring ≤7 on the Hamilton Depression Rating Scale (HDRS), 17-item; Treatment-Resistant Major Depression (TRMD) patients: Must meet a ≥17 score on the HDRS.
* Controls: Must not have any history of depression as determined by reported history and medical record review; TRMD: Documented (chart review) failure to respond to ≥3-4 adequate dose/duration antidepressant treatments; ≥1 in the current depressive episode.
* Good command of the English language
Exclusion Criteria:
* Meets criteria for any DSM-IV Axis I diagnosis as documented in medical records and as determined by structured clinical interview (except MDD for the TRMD group)
* Known primary neurological disorders or medical disorders including dementia, stroke, encephalopathy Parkinson's Disease, brain tumors, multiple sclerosis, seizure disorder, severe cardiac or pulmonary disease
* Any central nervous system active medication as determined by study investigator
* Any known disease affecting drug metabolism and excretion (e.g. renal or liver disease) as determined by study investigator
* Left-handedness
* Not eligible for MRI scans (e.g. history of claustrophobia/implanted metal as per MRI Screening Tool)
* Current use of psychotropic medications, antidepressants, or prescription or non-prescription drugs/herbals intended to treat depression or anxiety (control group only)
* Any recent (within past 12 months) history of substance dependence or abuse, determined by reported history or urine drug screen
* Ability to become pregnant and not using effective contraception
* Contraindication against the use of nitrous oxide:
1. Pneumothorax
2. Bowel obstruction
3. Middle ear occlusion
4. Elevated intracranial pressure
5. Chronic cobalamin and/or folate deficiency treated with folic acid or vitamin B12
6. Pregnant patients
7. Breastfeeding women
* Inability to provide informed consent
* Any other factor that in the investigators' judgment may affect patient safety or compliance (e.g. distance greater than 100 miles from clinic).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02994433
Study Brief:
Protocol Section:
NCT02994433