RecruitingPhase 3NCT05970510

A Study to Evaluate Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets in Generalized Anxiety Disorder.

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase Ⅲ Study to Evaluate the Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets in Participants With Generalized Anxiety Disorder.


Sponsor

Luye Pharma Group Ltd.

Enrollment

555 participants

Start Date

Jul 12, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The study aims to evaluate the efficacy and safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets compared to placebo in adults participants with generalized anxiety disorder over a period of 8 weeks.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a drug called toludesvenlafaxine hydrochloride sustained-release tablets for the treatment of generalized anxiety disorder (GAD). GAD is a condition where a person experiences persistent and difficult-to-control worry and anxiety that interferes with daily life. The study is testing whether this medication is effective and safe for adults with moderate to severe GAD. **You may be eligible if...** - You are between 18 and 65 years old - You have been diagnosed with generalized anxiety disorder (GAD) based on standard diagnostic criteria (DSM-5) - Your anxiety is moderate to severe, as measured by standard clinical scales (HAMA score ≥ 21 and CGI-S score ≥ 4) - You have significant anxious mood and tension as key symptoms **You may NOT be eligible if...** - You have another major psychiatric disorder such as depression (within the last 6 months), schizophrenia, bipolar disorder, OCD, PTSD, or an eating disorder - You have a history of substance or alcohol abuse in the last 6 months - Your anxiety is caused by a physical illness or another mental health condition - You are currently taking certain psychiatric medications without an adequate washout period - You have had brain surgery for psychiatric conditions - You are pregnant or planning to become pregnant 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

DRUGToludesvenlafaxine Hydrochloride Sustained-release Tablet 80mg

orally once a day

DRUGToludesvenlafaxine Hydrochloride Sustained-release Tablet 160mg

orally once a day

DRUGplacebo

orally once a day


Locations(1)

Peking University Sixth Hospital

Beijing, China

View Full Details on ClinicalTrials.gov

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NCT05970510


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