RecruitingPhase 3NCT06243614

Phase Ⅲ Clinical Trial of Buagafuran Capsules in the Treatment of GAD

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


Sponsor

Beijing Union Pharmaceutical Factory Ltd

Enrollment

410 participants

Start Date

Jul 24, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This is a Phase III clinical trial testing a drug called Buagafuran capsules — a new medication being studied for generalized anxiety disorder (GAD), a condition involving persistent, hard-to-control worry — to see if it is effective and safe compared to a placebo. **You may be eligible if...** - You are between 18 and 65 years old - You have been diagnosed with generalized anxiety disorder (GAD) according to established psychiatric criteria - Your anxiety is significant enough to require medication (anxiety scale score of 20 or higher) - You are an outpatient (not currently hospitalized) - You are able to give informed consent and attend follow-up visits **You may NOT be eligible if...** - You have significant depression alongside your anxiety (depression scale above 17) - You have active thoughts of suicide or a high suicide risk score - Your anxiety symptoms improved significantly between your screening and baseline visit (may indicate natural recovery) - You are currently participating in another drug trial - You have serious physical health conditions affecting heart, liver, or kidneys Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGBuagafuran capsules, 15mg/ capsule

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;

DRUGBuspirone tablets, 5mg/ tablet

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.

DRUGBuagafuran capsules mimic, 0mg/ capsule

Participants took Buagafuran capsules mimic daily. 2 to 4 capsules per time, twice per day, respectively, after breakfast and dinner for 8 weeks;

DRUGBuspirone tablets mimic, 0mg/ tablet

Participants took Buspirone tablets mimic daily. 1 to 4 tablets per time, twice per day, respectively, after breakfast and dinner for 8 weeks.


Locations(1)

Beijing Union Pharmaceutical Factory Ltd

Beijing, Beijing Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06243614


Related Trials