Cannabidiol for Treatment Resistant Depression

• Status: Withdrawn
• Trial end date: 2021-07-09
• Target enrollment: 0
• Participant gender: All

Summary

With this study, the investigators will address the following scientific aims:

1. Demonstrate the antidepressant effects of CBD in human adults with treatment refractory MDD as measured by standard rating scales.

2. Confirm CBD's safety profile in human adult patients with MDD.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham

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.