The study drug CD-008-0045 has a multi-targeted activity, i.e., able to inhibit adrenergic, dopamine, serotonin, and histamine receptors, thus allowing to assume its wide therapeutic potential. At Screening, the patients who meet the inclusion/exclusion criteria will be included into one-week single-blind Placebo Run-in period. At Week 0 the patients will be randomized to receive CD-008-0045 60 mg daily, CD-008-0045 40 mg daily or Placebo for 8 weeks. The potential withdrawal syndrome will be assessed during one-week Follow-up Period.
This is a multicenter, randomized, double-blind, placebo-controlled, dose-finding pilot study to assess the efficacy and safety of CD-008-0045 in patients with Generalized Anxiety Disorder (GAD). Each patient will participate in the study for the period of approximately 10 weeks: Screening and Run-in period: 1 week; Study Treatment period: 8 weeks; Follow-up period: 1 week.