At a glance
ClinicalIndex Comparison RecordPhase 3Recruiting· 504 target
Drug / intervention
Buagafuran capsules, 15mg/ capsule +1 moredrug
Likely dose
Buagafuran capsules, 15mg/ capsulefrom record
Key inclusion· 5
- ✓Outpatients aged 18-65 years old
- ✓DSM-5 criteria for GAD confirmed by M.I.N.I.
- ✓Requires psychiatric medication
- ✓HAMA score ≥20, HAMD-17 ≤2, CGI-S ≥4 at screening and baseline
Key exclusion· 27
- ✕Serious suicide risk or HAMD-17 item 3 ≥3
- ✕HAMD-17 > 17
- ✕HAMA score decreased ≥20% from screening to baseline
- ✕Other DSM-5 mental disorders except 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, Fixed-dose Phase Ⅲ Clinical Trial
In Brief
A Phase 3 clinical trial evaluating Buagafuran capsules, 15mg/ capsule and Buagafuran capsules mimic, 0mg/ capsule for Generalized Anxiety Disorder. Currently recruiting, targeting 504 participants across 1 site.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGeneralized Anxiety Disorder
CountriesChina
CollaboratorsR&G Pharma Studies Co.,Ltd.
Timeline
Phase 3Recruiting
2024202520262027
Enrollment StartJul 2023
First PostedFeb 2024
Primary CompletionJun 2026
TodayJul 2026
Study CompletionJun 2027
First PostedFeb 6, 2024
Enrollment StartJul 25, 2023
Primary CompletionJun 30, 2026
Study CompletionJun 30, 2027
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 2.4 years ago
Interventions
Buagafuran capsules, 15mg/ capsuledrug
Subjects took Buagafuran capsules; twice per day, respectively, after breakfast and dinner for 8 weeks;
Buagafuran capsules mimic, 0mg/ capsuledrug
Subjects took Buagafuran capsules mimic. twice per day, respectively, after breakfast and dinner for 8 weeks;