NCT07330648

Prospective Clinical Trial of Crisugabalin Capsules in the Treatment of Generalized Anxiety Disorder

Evaluation of the Efficacy and Safety of Crisugabalin Capsules Versus Placebo and Venlafaxine Extended-Release (XR) Capsules in Chinese Patients With Generalized Anxiety Disorder: A Prospective, Multicenter, Randomized, Double-Blind, Double-Dummy, Active- and Placebo-Controlled Clinical Trial.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 216 (estimated)
• Sponsor: Anhui Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A placebo-controlled superiority design was used to evaluate the efficacy of 40 mg/ day of Crisugabalin capsules in the treatment of GAD.

Detailed description

This was a prospective, multicenter, randomized, double-blind, double-dummy, active- and placebo-controlled clinical trial. Qualified subjects, according to the ratio of 1:1:1, were randomized into Crisugabalin group, Venlafaxine-control group and placebo-control group, and received a double-blind treatment course of 8 weeks. After completing the 8-week double-blind treatment period, subjects will officially conclude the study or voluntarily enter a 4-week open-label extension treatment phase. During the open-label extension phase, all subjects will receive Crisugabalin 80 mg/day (40 mg bid). Participants were followed from baseline outpatient visit until end of the follow-up period (14 weeks and 9 visits in total).

Conditions

• Generalized Anxiety Disorder

Interventions

Type	Name	Description
DRUG	Crisugabalin 20mg bid	Crisugabalin 20mg bid Crisugabalin 20mg, orally twice a day; treatment period: 8 weeks fixed dose. Open-label extension phase: Crisugabalin 40mg, orally twice a day; treatment period: 4 weeks fixed dose.
DRUG	Venlafaxine-XR 75mg bid	Venlafaxine-XR 75mg bid Venlafaxine-XR 75mg, orally once a day and the second dose of placebo was administered; treatment period: 8 weeks fixed dose.
DRUG	Crisugabalin capsules mimic 0mg/capsule bid	Crisugabalin capsules mimic 0mg/capsule, orally twice a day; treatment period: 8 weeks fixed dose. Drug: Venlafaxine-XR capsules mimic, 0mg/capsule, bid Drug: Venlafaxine-XR capsules mimic, 0mg/capsule, bid Venlafaxine-XR capsules mimic, 0mg/capsule, orally twice a day; treatment period: 8 weeks fixed dose.

Timeline

• Start date: 2025-10-10
• Primary completion: 2027-01-31
• Completion: 2027-02-28
• First posted: 2026-01-09
• Last updated: 2026-01-09

Locations

1 site across 1 country: China