Phase Ⅲ Clinical Trial of Buagafuran Capsules in the Treatment of GAD
ConditionGeneralized Anxiety Disorder
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBeijing Union Pharmaceutical Factory Ltd
About this trial
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 criteria
Qualifiers
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;
Disqualifiers
Patients with serious suicide risk at present, or HAMD-17 item 3-suicide score ≥3;
Patients with HAMD-17 > 17;
Those who met the DSM-5 diagnostic criteria for other mental disorders except GAD;
Patients 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;
Trial design
Treatments tested in this trial
- Buagafuran capsules, 15mg/ capsule
- Buspirone tablets, 5mg/ tablet
- Buagafuran capsules mimic, 0mg/ capsule
- Buspirone tablets mimic, 0mg/ tablet
Treatment groups
410 Participants
are divided into 3 treatment groupsSponsors and collaborators
Beijing Union Pharmaceutical Factory Ltd
Lead sponsor
R&G Pharma Studies Co.,Ltd.
Collaborator
Source ClinicalTrials.gov