Social Anxiety Disorder Clinical Trial
Official title:
A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study, Evaluating the Efficacy, Safety, and Tolerability of Cannabidiol Oral Solution in Subjects With Social Anxiety Disorder
Verified date | September 2023 |
Source | EmpowerPharm Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A phase 2, multicenter, double-blind, parallel group, placebo-controlled, randomized clinical study, designed to compare the efficacy, safety, and tolerability of 2 dose levels of CBD and a matching placebo for the treatment of subjects with Social Anxiety Disorder (SAD).
Status | Active, not recruiting |
Enrollment | 225 |
Est. completion date | December 2023 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | EPI-CBD-001 Site | Bellevue | Washington |
United States | EPI-CBD-001 Site | Cedarhurst | New York |
United States | EPI-CBD-001 Site | Chicago | Illinois |
United States | EPI-CBD-001 Site | Encino | California |
United States | EPI-CBD-001 Site | Jacksonville | Florida |
United States | EPI-CBD-001 Site | Lauderhill | Florida |
United States | EPI-CBD-001 Site | Lemon Grove | California |
United States | EPI-CBD-001 Site | Los Alamitos | California |
United States | EPI-CBD-001 Site | Maitland | Florida |
United States | EPI-CBD-001-Site | New York | New York |
United States | EPI-CBD-001-Site | Oceanside | California |
United States | EPI-CBD-001 Site | Oklahoma City | Oklahoma |
United States | EPI-CBD-001 Site | Orlando | Florida |
United States | EPI-CBD-001 Site | Portland | Oregon |
United States | EPI-CBD-001-Site | Rochester | New York |
United States | EPI-CBD-001 site | San Jose | California |
United States | EPI-CBD-001 site | Wichita Falls | Texas |
Lead Sponsor | Collaborator |
---|---|
EmpowerPharm Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean change from baseline to endpoint in the Liebowitz Social Anxiety Scale (LSAS) | 10 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
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