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

NCT07330648 | Recruiting Phase 2

• 1 other identifier: HSK16149-502
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in Hamilton Anxiety (HAMA) scale score after 8 week treatment

  The Hamilton Anxiety (HAMA) scale score reflects the severity of the subjects anxiety symptoms. The primary efficacy end point was the change from baseline to week 8 in HAMA total score to determine the superiority of crisugabalin capsules over placebo. The larger the difference between crisugabalin capsules over placebo, the better the curative effect.The HAMA consists of 14 items that encompass both psychological and somatic symptoms of anxiety. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.

  from baseline to week 8

Secondary Outcomes (7)

• Change in Hamilton anxiety scale score after treatment

  from baseline to week 8

• Change in each factor score and item score of Hamilton anxiety scale

  from baseline to week 8

• Clinical global impression of improvement score

  the end of week 4 and 8

• Clinical global impression of severity score

  the end of week 4 and 8

• Complete remission rate

  the end of week 8

Other Outcomes (2)

• Exploratory Analysis

  Form baseline to week 8

• Adverse events (AEs）

  Form baseline to week 8

Study Arms (3)

Crisugabalin 80mg/day group

EXPERIMENTAL

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: Crisugabalin 20mg bid

Venlafaxine Extended-Release (XR) Capsules 150mg/day group

EXPERIMENTAL

Drug: 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: Venlafaxine-XR 75mg bid

Placebo-Control group

PLACEBO COMPARATOR

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 Venlafaxine-XR capsules mimic, 0mg/capsule, orally twice a day; treatment period: 8 weeks fixed dose.

Drug: Crisugabalin capsules mimic 0mg/capsule bid

Interventions

Crisugabalin 20mg bid DRUG

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.

Also known as: HSK16149

Crisugabalin 80mg/day group

Venlafaxine-XR 75mg bid DRUG

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.

Also known as: Venlafaxine-XR

Venlafaxine Extended-Release (XR) Capsules 150mg/day group

Crisugabalin capsules mimic 0mg/capsule bid DRUG

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.

Also known as: Crisugabalin capsules mimic, Venlafaxine-XR capsules mimic

Placebo-Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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);
• subjects with a history of epilepsy or any other disease that may induce seizures, except convulsions caused by febrile convulsions in children;
• Severe hematologic, hepatic or renal dysfunction during the screening period, the subject will be excluded if: a. Neutrophils \< 1.5 × 10\^9/L, or platelet \< 90 × 10\^9/L, or hemoglobin \< 100 g/L; b. AST/ALT \> 2.5 × upper limit of normal (ULN), or TBIL \> 1.5 × ULN; c. Estimation of glomerular filtration rate (eGFR) \< 60 mL/min / 1.73 m\^2; d. Creatine kinase \> 2.0 × ULN.
• Clinically significant abnormalities on electrocardiography (QT interval corrected by Fridericia method: ≥450 ms for men or ≥470 ms for women) or conditions deemed ineligible by the investigators;
• Subjects who had undergone psychiatric surgery, electroconvulsive therapy or transcranial magnetic stimulation within 90 days before screening;
• Use of β-blockers within 90 days prior to screening with an ongoing need for continued treatment;

Sponsors & Collaborators

• Anhui Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230000, China

RECRUITING

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

BID protein, human; tebufenozide

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Central Study Contacts

Kai Wang

CONTACT

+8613805512494; wangkai1964@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The First Affiliated Hospital of Anhui Medical University

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: January 9, 2026
• Study Start: October 10, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: January 9, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)