Phase 3 Clinical Trial of Buagafuran Capsules in the Treatment of GAD
Trial Parameters
Brief Summary
A placebo-controlled superiority design was used to evaluate the efficacy of 60 mg/ day or 120 mg/ day of Buagafuran capsules in the treatment of GAD
Eligibility Criteria
Inclusion Criteria: 1. Outpatients aged 18-65 years old, of both sexes; 2. Met the diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for generalized anxiety disorder (GAD) and confirmed by the Brief International Neuropsychiatric Interview (M.I.N.I.); 3. The patient requires psychiatric medication; 4. Hamilton Anxiety Scale (HAMA) score ≥20, Hamilton Depression Scale (HAMD-17) score ≤2, Clinical Global Impression Scale (CGI-S) score ≥4 at screening and baseline Points; 5. Able to understand and voluntarily participate in this trial, signed informed consent. Exclusion Criteria: 1. Patients with serious suicide risk at present, or HAMD-17 item 3-suicide score ≥3; 2. Patients with HAMD-17 \> 17; 3. Patients whose HAMA scores decreased by ≥20% in the baseline period compared with the screening period: 4. Those who met the DSM-5 diagnostic criteria for other mental disorders except GAD; 5. Patients with previous history of depression, obsessive-compulsive d