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Prospective Clinical Trial of Crisugabalin Capsules in the Treatment of Generalized Anxiety Disorder | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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.

NCT07330648•Anhui Medical University

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Able to understand and voluntarily participate in the trial, and provide written informed consent form (ICF);
•Male or female aged ≥18 years (inclusive of the threshold value);
•Met the diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for generalized anxiety disorder (GAD) and confirmed by the Brief International Neuropsychiatric Interview (M.I.N.I.);
•Require pharmacological treatment for psychiatric symptoms;
•Hamilton Anxiety Scale (HAMA) score ≥20, Hamilton Depression Scale (HAMD-17) score ≤2, Clinical Global Impression Scale (CGI-S) score ≥4 at screening and baseline Points;

Exclusion Criteria

•subjects with serious suicide risk at present, or HAMD-17 item 3-suicide score ≥3;
•subjects with HAMD-17 \> 17;
•subjects whose HAMA scores decreased by ≥20% in the baseline period compared with the screening period:
•Those who met the DSM-5 diagnostic criteria for other mental disorders except GAD;
•subjects with previous history of depression, obsessive-compulsive disorder, bipolar disorder, psychotic disorder, factitious disorder and somatoform disorder; There were severe personality disorders, especially antisocial, borderline, or histrionic personality disorder, which were judged by the investigator to affect the patient's adherence to the study protocol;
•Alcohol or drug abuse or dependence within 180 days before screening;
•With severe or unstable has clinical significance of somatic disease, including any cardiovascular, cancer, kidney, respiratory, endocrine (including abnormal thyroid function), digestion, blood (such as with bleeding tendency) or nervous system diseases;
•History of inadequate response to at least two prior antidepressant drugs and/or benzodiazepines after adequate dose and duration of treatment (i.e., at least 4 weeks at a clinically appropriate dose), or failure to achieve sufficient clinical efficacy with pregabalin ≥300 mg/day (i.e., subject-reported insufficient response or lack of meaningful clinical improvement).
•History of severe hypersensitivity reactions (e.g., anaphylaxis) or allergies to at least two classes of drugs (including photosensitivity), or known hypersensitivity to pregabalin, the investigational drug, structurally related compounds, or any of their excipients.
•subjects whose physical examination or vital signs were abnormal and clinically significant (e.g. inadequately controlled hypertension, systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg);
+14 more criteria

Locations (1)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Key Dates

Start Date

October 10, 2025

Primary Completion Date

January 31, 2027

Completion Date

February 28, 2027

Last Updated

January 9, 2026

Enrollment

216

ESTIMATED participants

Conditions

Generalized Anxiety Disorder

Interventions

Crisugabalin 20mg bid

DRUG

Venlafaxine-XR 75mg bid

DRUG

Crisugabalin capsules mimic 0mg/capsule bid

DRUG

Contacts

Kai Wang

CONTACT

+8613805512494 wangkai1964@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 9, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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