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 @ 3:51 PM
Ignite Modification Date:
2025-12-24 @ 3:51 PM
NCT ID:
NCT05095792
Eligibility Criteria:
Inclusion Criteria:
1. Primary Diagnostic and Statistical Manuel of Mental Disorders 5 (DSM-V) diagnosis of treatment-resistant Major Depressive Disorder (may have secondary diagnoses of general anxiety, substance disorder)
* Non-responders to at least 2 previous anti-depressant medications prescribed by a physician in the past five years
* Score of ≥20 on Montgomery-Asberg Depression Rating Scale (MADRS) (i.e., moderate to severe depression)
2. All genders aged 21 to 60 years of age
3. Prescribed Ketamine or currently being treated with Ketamine for treatment-resistant Major Depressive Disorder
4. Willing to wear an Electroencephalogram (EEG) headset and an eye mask
5. Willing to listen to ambient sound
6. Willing to have a genetic cheek swab
Exclusion Criteria:
1. Pregnancy
2. Traumatic Brain Injury within past 3 months
3. Body weight \< 50 kg or \> 120 kg
4. Coronary heart disease
5. Uncontrolled hypertension as defined in the American College of Cardiology/American Heart Association (ACC/AHA) Hypertension Guidelines
6. Previous contact with Ketamine (therapeutically or recreationally) outside of treatment at the study site
7. Primary psychotic disorder (e.g., schizophrenia, schizoaffective disorder)
8. Bipolar disorder with current manic, hypomanic or mixed state
9. Post-traumatic stress disorder
10. Obsessive-compulsive disorder
11. Primary substance-use disorder
12. Alcohol consumption 24 hours prior and 48 hours subsequent to treatment
13. Currently using any of the following medications:
* Benzodiazepines for 6 hours prior to treatment and 2 hours after treatment
* Lamotrigine for 6 hours prior to treatment
* Amphetamine-based stimulants for 6 hours prior to treatment
* Monoamine Oxidase Inhibitors (MAO-Is) may be taken but blood pressure must be monitored
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
60 Years
Study:
NCT05095792
Study Brief:
Protocol Section:
NCT05095792