Safety and Efficacy of Buagafuran Capsules in the Treatment of Generalized Anxiety Disorder: a Multi-center, Randomized, Double-blind, Double-dummy, Placebo-controlled, Positive-controlled, Flexible-dose Phase Ⅲ Clinical Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
A placebo-controlled superiority design was used to evaluate the efficacy of 60-120 mg/ day of Buagafuran capsules in the treatment of GAD.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Outpatients aged 18-65 years old, of both sexes;
• 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.);
• The patient requires psychiatric medication;
• 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;
• Able to understand and voluntarily participate in this trial, signed informed consent.
Locations
Other Locations
China
Beijing Union Pharmaceutical Factory Ltd
RECRUITING
Beijing
Contact Information
Primary
Tao Sun
sunny.suntao@aliyun.com
13621169498
Time Frame
Start Date: 2023-07-24
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 410
Treatments
Experimental: Experimental group
Participants took 60-120 mg/day Buagafuran capsules and Buspirone tablets mimic; 2 times per day, after breakfast and dinner, consecutively for 8 weeks; The dose can be adjusted according to treatment needs and tolerance in the follow-up period( at week 1, week 2 and week 4).
Active_comparator: Positive-control group
Participants took 10-20mg/day Buspirone tablets and Buagafuran capsules mimic; 2 times per day, after breakfast and dinner, consecutively for 8 weeks; The dose can be adjusted according to treatment needs and tolerance in the follow-up period( at week 1, week 2 and week 4).
Placebo_comparator: Placebo-control group
Participants took Buagafuran capsules mimic and Buspirone tablets mimic; 2 times per day, after breakfast and dinner, consecutively for 8 weeks; The dose can be adjusted according to treatment needs and tolerance in the follow-up period( at week 1, week 2 and week 4).
Related Therapeutic Areas
Sponsors
Collaborators: R&G Pharma Studies Co.,Ltd.
Leads: Beijing Union Pharmaceutical Factory Ltd