A placebo-controlled superiority design was used to evaluate the efficacy of 40 mg/ day of Crisugabalin capsules in the treatment of GAD.
Able to understand and voluntarily participate in the trial, and provide written informed consent form (ICF);
Male or female aged ≥18 years (inclusive of the threshold value);
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.);
Require pharmacological treatment for psychiatric symptoms;
subjects with serious suicide risk at present, or HAMD-17 item 3-suicide score ≥3;
subjects with HAMD-17 > 17;
Those who met the DSM-5 diagnostic criteria for other mental disorders except GAD;
subjects with previous history of depression, obsessive-compulsive disorder, bipolar disorder, psychotic disorder, factitious disorder and somatoform disorder; There were severe personality disorders, especially antisocial, borderline, or histrionic personality disorder, which were judged by the investigator to affect the patient's adherence to the study protocol;