RecruitingPhase 2NCT07330648

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.


Sponsor

Anhui Medical University

Enrollment

216 participants

Start Date

Oct 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called crisugabalin for the treatment of generalized anxiety disorder (GAD) — a condition where people feel persistent, hard-to-control worry and anxiety about everyday situations. Researchers are evaluating the drug's safety and effectiveness in adults. **You may be eligible if...** - You are 18 or older (male or female) - You have been diagnosed with generalized anxiety disorder (GAD) according to DSM-5 criteria, confirmed with a structured clinical interview - You need medication to manage your anxiety symptoms - Your anxiety score (HAMA) is 20 or higher and your depression score is low - Your overall clinical impression of illness severity is at least moderate **You may NOT be eligible if...** - You have significant suicidal thoughts or have scored high on suicide risk assessments - You have significant depression alongside your anxiety (HAMD-17 score above 17) - Your anxiety scores dropped significantly during the screening period (may indicate a placebo response) - You have another psychiatric condition such as bipolar disorder, OCD, psychotic disorder, or severe personality disorder - You have a history of depression, obsessive-compulsive disorder, or somatoform disorder 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.

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Interventions

DRUGCrisugabalin 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.

DRUGVenlafaxine-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.

DRUGCrisugabalin 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.


Locations(1)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

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NCT07330648


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