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

NCT07330648 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2026-01-09

No results posted yet for this study

Summary

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

Conditions

  • Generalized Anxiety Disorder

Interventions

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.

Sponsors & Collaborators

  • Anhui Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-10
Primary Completion
2027-01-31
Completion
2027-02-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07330648 on ClinicalTrials.gov