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 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT04732169
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-65 years old
2. Sufficient fluency in English to understand testing procedures and provide written informed consent
3. A Hamilton Depression Rating Scale total score greater than 18
4. A DSM 5 diagnosis of MDD based on the MINI.
5. No evidence of alcohol or other substance use disorder in the past 3 months
6. For females: no current pregnancy or lactation (women of reproductive potential must have a negative urine pregnancy test at screening).
7. Depressed patients who have failed at least one adequate antidepressant trial during the current depressive episode based on the ATRQ.
Exclusion Criteria:
8. No diagnosis of other primary psychiatric disorder (defined in this case as being the main focus of treatment) as determined by the MINI, such as: bipolar disorder, personality disorders, psychotic disorders, post-traumatic stress disorder, obsessive-compulsive disorder, dissociative disorders, eating disorder, or cognitive task due to neurological conditions
9. Systolic blood pressure \< 150 and/or diastolic blood pressure \< 90 at screening
10. A QTc F\< 480 as determined by an ECG
11. No post-partum state (being within 2 months of delivery or miscarriage)
12. Imminent suicide or homicide risk as determined by the investigator
13. No history of using prescription Epidiolex for any indication.
14. Not being treated with one of the following medications: benzodiazepines or other CNS depressants.
15. Not using concomitant medications that are moderate or strong CYP3A4 or CYP2C19 inhibitors.
16. None of the following clinically-significant medication condition or therapy that would preclude treatment with ketamine, to include: Recent myocardial infarction, unstable angina, malignant neoplasm in the past 6 months, immunosuppressive or corticosteroid therapy within the last month, with the following exceptions: any inhaled, intranasal, topical or vaginal corticosteroids are allowed, chemotherapy.
17. No clinically significant neurological disease based on medical history (e.g., epilepsy) or significant head injury.
18. Any of the following disorders: Rheumatoid arthritis; Lupus erythematosus; Autoimmune hepatitis; Autoimmune peripheral neuropathy; Autoimmune pancreatitis; Behcet's disease; Crohn's disease; Autoimmune glomerulonephritis; Grave's disease; Guillain-Barre syndrome; Hashimoto's thyroiditis; Autoimmune polymyositis or polymyalgia; Myasthenia gravis; Narcolepsy; Polyarteritis nodosa; Scleroderma; Sjogren's syndrome; Transverse myelitis; Wegener's granulomatosis; History of seizures (only childhood febrile seizures are allowed)
19. The presence of clinically significant laboratory findings in the opinion of the investigator including, but not limited to, clinically significant anemia or transaminase elevation.
20. If the UDS is positive, the subject would be excluded if, in the opinion of the investigator, the positive UDS meant the subject has an active substance use disorder.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04732169
Study Brief:
Protocol Section:
NCT04732169