Cannabidiol (CBD) for the Treatment of Social Anxiety Disorder
Social Anxiety Disorder
About this trial
This is an interventional treatment trial for Social Anxiety Disorder
Eligibility Criteria
Inclusion Criteria: Clinically predominant diagnosis of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) SAD LSAS score of 70 or higher Females of childbearing potential must test negative for pregnancy and agree to use a reliable birth control method. Male subjects must also agree to use highly effective methods of contraception. Read, understand, and sign the informed consent form. No significant physical health abnormalities based on physical exam, ECG and laboratory tests. Exclusion Criteria: Other current psychiatric disorder as the clinically predominant diagnosis. Lifetime diagnosis of schizophrenia or any other psychosis, MDD with psychotic features, intellectual disability, autism spectrum disorders, bipolar disorder type 1, and cannabis use disorder Previous 6 months diagnosis of Post-traumatic stress disorder, obsessive compulsive disorder, moderate to severe alcohol use disorder, and substance abuse disorder (except tobacco use disorder or mild alcohol use disorder) Severe MDD Use of oral psychoactive medications or beta adrenergic antagonists in the past 4 weeks, or depot neuroleptics within 12 weeks Electroconvulsive therapy within 6 months, psychotherapy or transcranial magnetic stimulation within 3 months Clinically significant abnormality or clinically significant unstable medical condition Impaired liver function Significant risk of suicide or homicide Pregnancy/lactation Sensitivity to CBD or excipients Current cannabis use; past frequent cannabis use Illegal drug use
Sites / Locations
- EPI-CBD-001 Site
- EPI-CBD-001 Site
- EPI-CBD-001 Site
- EPI-CBD-001-Site
- EPI-CBD-001 site
- EPI-CBD-001 Site
- EPI-CBD-001 Site
- EPI-CBD-001 Site
- EPI-CBD-001 Site
- EPI-CBD-001 Site
- EPI-CBD-001 Site
- EPI-CBD-001-Site
- EPI-CBD-001-Site
- EPI-CBD-001 Site
- EPI-CBD-001 Site
- EPI-CBD-001 site
- EPI-CBD-001 Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Cannabidiol (CBD) Oral Solution 300 mg/day
Cannabidiol (CBD) Oral Solution 600 mg/day
Placebo Oral Solution