Cariprazine Versus Placebo for Social Anxiety Disorder (NCT05384483) | Clinical Trial Compass
CompletedPhase 4
Cariprazine Versus Placebo for Social Anxiety Disorder
United States40 participantsStarted 2022-07-18
Plain-language summary
The proposed study is a 12 week double-blind, placebo-controlled trial to examine the efficacy, safety, and tolerability of Vraylar® (cariprazine) in the treatment of patients with Social Anxiety Disorder (SAD), as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5). Subjects will be randomized to one of two treatment arms (placebo or Vraylar® 1.5 mg/day) in a 1:1 ratio. The study will be done at a single clinical research site.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Male and female adults between 18 and 65 years of age (inclusive).
* Subjects must give written informed consent prior to any study procedures.
* Diagnosis of Social Anxiety Disorder (SAD) (300.23 Social Anxiety Disorder) according to DSM-5 criteria, as determined by psychiatric evaluation with the Investigator and confirmed by the Mini-International Neuropsychiatric Interview (MINI).
* Subjects must have a minimum total score of 70 on the LSAS at both Screening and Baseline visits.
* Subjects must have a total Hamilton Depression Rating Scale (HAM-D) score of less than 16 at the Screening and Baseline visits.
* Subjects must have a Clinical Global Impression of Severity (CGI-S) score of 4 or greater at both Screening and Baseline visits.
* All subjects of childbearing potential must commit to an effective form of contraception for the duration of the trial and for at least 4 weeks after it ends. Effective forms of contraception include: condoms with spermicide, diaphragm with spermicide, hormonal contraceptive agents (oral, transdermal, or injectable), or implantable contraceptive devices. Abstinence from heterosexual intercourse will also be considered an effective form of contraception, if abstinence is part of the subject's usual lifestyle.
Exclusion Criteria:
* Subjects with any Axis I disorder other than SAD (e.g., post-traumatic stress disorder, obsessive compulsive disorder, panic disorder) within 24 weeks of the Baseline visit. Subjects with …