At a glance
ClinicalIndex Comparison Record- ✓Outpatients aged 18-65 years old, of both sexes
- ✓Met DSM-5 criteria for GAD confirmed by M.I.N.I.
- ✓Requires psychiatric medication
- ✓HAMA score ≥20, HAMD-17 score ≤2, CGI-S score ≥4 at screening and baseline
- ✕Serious suicide risk present or HAMD-17 item 3-suicide score ≥3
- ✕HAMD-17 > 17
- ✕HAMA scores decreased by ≥20% from screening to baseline period
- ✕DSM-5 diagnosis of mental disorders other than GAD
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Buagafuran capsules, 15mg/ capsule, Buspirone tablets, 5mg/ tablet, and 2 other interventions for Generalized Anxiety Disorder. Currently recruiting, targeting 410 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Participants took 60-120 mg Buagafuran capsules daily. The initial dose was 60mg/ day, 2 to 4 capsules per time, twice per day, respectively, after breakfast and dinner for 8 weeks;
Participants took 10-20mg Buspirone tablets daily. The initial dose was 10mg/ day, 1 to 4 tablets per time, twice per day, respectively, after breakfast and dinner for 8 weeks.
Participants took Buagafuran capsules mimic daily. 2 to 4 capsules per time, twice per day, respectively, after breakfast and dinner for 8 weeks;
Participants took Buspirone tablets mimic daily. 1 to 4 tablets per time, twice per day, respectively, after breakfast and dinner for 8 weeks.