Jason Careri
The goal of this clinical trial is to learn if Caplyta works to treat Social Anxiety Disorder in adults. The main question it aims to answer is: Does Caplyta lower the frequency/severity of social anxiety symptoms in adults? Researchers will compare Caplyta to a placebo (a look-alike substance that contains no drug) to see if Caplyta works to treat Social Anxiety Disorder. Participants will: Take Caplyta or a placebo every day for 8 weeks Visit the clinic once every week for checkups and tests
Inclusion Criteria: 1. Male and female adults between 18 and 65 years of age (inclusive). 2. Written informed consent given prior to any study procedures. 3. Diagnosis of Social Anxiety Disorder (SAD) according to DSM-5 criteria, as determined by psychiatric evaluation with the Investigator and as confirmed by the MINI at Screening. 4. Minimum total score of 70 on the LSAS at Screening and Baseline visits. 5. Total Hamilton Depression Rating Scale (HAM-D) score of less than 16 at Screening and Baseline. 6. Clinical Global Impression of Severity (CGI-S) score of 4 or greater at Screening and B…
Lumateperone (Caplyta) 42 mg daily for adults with Social Anxiety Disorder
Matching placebo for lumateperone (Caplyta) 42 mg
Arctuva estimate
Verify or correct the compensation shown for this listing.