Actively Recruiting
Phase 3 Clinical Trial of Buagafuran Capsules in the Treatment of GAD
Led by Beijing Union Pharmaceutical Factory Ltd · Updated on 2024-02-06
504
Participants Needed
1
Research Sites
205 weeks
Total Duration
On this page
Sponsors
B
Beijing Union Pharmaceutical Factory Ltd
Lead Sponsor
R
R&G Pharma Studies Co.,Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Phase 3 Clinical Trial of Buagafuran Capsules in the Treatment of GAD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Outpatients aged 18-65 years old of any gender
- Diagnosed with generalized anxiety disorder according to DSM-5 and confirmed by the Brief International Neuropsychiatric Interview (M.I.N.I.)
- Require psychiatric medication for treatment
- Hamilton Anxiety Scale (HAMA) score of 20 or higher, Hamilton Depression Scale (HAMD-17) score of 2 or less, and Clinical Global Impression Scale (CGI-S) score of 4 or higher at screening and baseline
- Able to understand the study and provide signed informed consent
You will not qualify if you...
- Serious suicide risk or HAMD-17 item 3-suicide score of 3 or higher
- Hamilton Depression Scale (HAMD-17) score above 17
- Decrease in Hamilton Anxiety Scale (HAMA) score by 20% or more during baseline period compared to screening
- Diagnosis of other mental disorders besides generalized anxiety disorder
- History of depression, obsessive-compulsive disorder, bipolar disorder, psychotic disorder, factitious disorder, somatoform disorder, or severe personality disorders affecting study adherence
- Alcohol or drug abuse within 180 days before screening
- Severe or unstable significant physical illnesses including cardiovascular, cancer, kidney, respiratory, endocrine, digestive, blood, or nervous system diseases
- Abnormal physical exam or vital signs such as uncontrolled hypertension
- History of epilepsy or seizure-inducing conditions except febrile convulsions in childhood
- Significant abnormalities in lab tests including liver and kidney function
- Clinically important electrocardiographic abnormalities
- Psychiatric surgery, electroconvulsive therapy, or transcranial magnetic stimulation within 90 days before screening
- Treatment with beta-blockers within 90 days before screening
- Severe hypersensitivity or allergy to at least two drugs
- Prior use of two or more antidepressants or benzodiazepines at adequate doses for at least 4 weeks without effect
- Systemic psychotherapy or non-drug treatments within 6 weeks before baseline
- Recent benzodiazepine or monoamine oxidase inhibitor use within specified windows before screening
- Use of antipsychotics, antidepressants, or mood stabilizers with less than five half-lives washout before baseline
- Recent discontinuation of traditional Chinese medicine, melatonin, or St. John's wort within 3 days before baseline
- Inability to avoid grapefruit or grapefruit juice during drug administration
- Pregnancy or lactation without effective contraception
- Inability to take medicine as prescribed
- Participation in other clinical trials within 90 days before screening
- Any other condition judged by investigators to make participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Union Pharmaceutical Factory Ltd
Beijing, Beijing Municipality, China, 102600
Actively Recruiting
Research Team
T
Tao Sun
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
3
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