Cannabidiol for Treatment Resistant Depression (CBD)
Treatment Resistant Depression
About this trial
This is an interventional treatment trial for Treatment Resistant Depression
Eligibility Criteria
Inclusion Criteria:
- Age 18-65 years old
- Sufficient fluency in English to understand testing procedures and provide written informed consent
- A Hamilton Depression Rating Scale total score greater than 18
- A DSM 5 diagnosis of MDD based on the MINI.
- No evidence of alcohol or other substance use disorder in the past 3 months
- For females: no current pregnancy or lactation (women of reproductive potential must have a negative urine pregnancy test at screening).
Depressed patients who have failed at least one adequate antidepressant trial during the current depressive episode based on the ATRQ.
Exclusion Criteria:
- 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
- Systolic blood pressure < 150 and/or diastolic blood pressure < 90 at screening
- A QTc F< 480 as determined by an ECG
- No post-partum state (being within 2 months of delivery or miscarriage)
- Imminent suicide or homicide risk as determined by the investigator
- No history of using prescription Epidiolex for any indication.
- Not being treated with one of the following medications: benzodiazepines or other CNS depressants.
- Not using concomitant medications that are moderate or strong CYP3A4 or CYP2C19 inhibitors.
- 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.
- No clinically significant neurological disease based on medical history (e.g., epilepsy) or significant head injury.
- 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)
- The presence of clinically significant laboratory findings in the opinion of the investigator including, but not limited to, clinically significant anemia or transaminase elevation.
- 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.
Sites / Locations
- University of Alabama at Birmingham
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Epidiolex (cannabidiol) (CBD)
Placebo
During the first week after randomization, participants will receive 125mg of Epidiolex (CBD) or matching placebo taken twice daily (250mg/day). During the second week after randomization, the dosage will be increased to 250mg of Epidiolex or placebo taken twice daily (500mg/day) for one week. During the third week after randomization, the dosage will be increased to 500mg of Epidiolex (CBD) or matching placebo taken twice daily (1000mg/day). Participants will remain on 1000mg/day of Epidiolex (CBD) or matching placebo for four more weeks, at which point they will be stepped down to 500mg/day of Epidiolex (CBD) or placebo for one week, followed by 250mg/day of Epidiolex (CBD) or placebo for one week.
During the first week after randomization, participants will receive 125mg of Epidiolex (CBD) or matching placebo taken twice daily (250mg/day). During the second week after randomization, the dosage will be increased to 250mg of Epidiolex or placebo taken twice daily (500mg/day) for one week. During the third week after randomization, the dosage will be increased to 500mg of Epidiolex (CBD) or matching placebo taken twice daily (1000mg/day). Participants will remain on 1000mg/day of Epidiolex (CBD) or matching placebo for four more weeks, at which point they will be stepped down to 500mg/day of Epidiolex (CBD) or placebo for one week, followed by 250mg/day of Epidiolex (CBD) or placebo for one week.