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.

Luye Pharma Group Ltd.1 site in 1 country555 target enrollmentJuly 12, 2023

InterventionsToludesvenlafaxine Hydrochloride Sustained-release Tablet 80mg Toludesvenlafaxine Hydrochloride Sustained-release Tablet 160mg placebo

DrugsToludesvenlafaxine Hydrochloride Sustained-release Tablet 80mg Toludesvenlafaxine Hydrochloride Sustained-release Tablet 160mg placebo

Overview

Phase: Phase 3
Intervention: Toludesvenlafaxine Hydrochloride Sustained-release Tablet 80mg
Conditions: Generalized Anxiety Disorder
Sponsor: Luye Pharma Group Ltd.
Enrollment: 555
Locations: 1
Primary Endpoint: Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale total score at endpoint
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed Description

The study consists of two periods: screening period (2 weeks) and double-blind treatment period (8 weeks). After the screening period, generalized anxiety disorder patients who satisfies the inclusion criteria are randomly assigned in the 1:1:1 ratio to receive either placebo or Toludesvenlafaxine Hydrochloride Sustained-release Tablets at two dose levels (80 ,160 mg/day) for 8 weeks. Participants are evaluated at screening, baseline visits and double-blind period.

Registry

clinicaltrials.gov

Start Date

July 12, 2023

End Date

April 30, 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Luye Pharma Group Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female aged 18 to 65 years subjects;
•Meet the Diagnostic and Statistical Manual of Manual Disorders, fifth Edition(DSM-5) criteria for Generalized Anxiety Disorder;
•Have a Hamilton Anxiety(HAMA) Rating Scale total score ≥21 points at screening and baseline;
•Have a Hamilton Anxiety(HAMA) Rating Scale score ≥2 points on both item 1(anxious mood) and item 2(tension) at screening and baseline;
•Have a clinical Global Impression -severity illness (CGI-S) score≥4 points at screening and baseline.

Exclusion Criteria

•Meet the diagnostic criteria for other psychotic disorders(defined by DSM-5, except for GAD), including major depression disorder within 6 months prior to screening , presence or history of Schizophrenia Spectrum and Other Psychotic Disorders, Bipolar and Related Disorders, Obsessive-Compulsive and related Disorders, post-traumatic stress disorder, anorexia nervosa or bulimia and personality disorder;
•Meet the diagnostic criteria for substance or alcohol abuse (defined by DSM-5, except for nicotine or caffeine) within 6 months prior to screening;
•Have anxious symtoms secondary to other physical illnesses or mental illnesses and anxious induced by psychoactive substance;
•Withdrawal psychotropic drugs within 5 half-lives (at least 2 weeks for monoamine oxidase inhibitors, at least 1 month for fluoxetine, and at least 2 weeks for benzodiazepines or barbiturates) prior to randomization;
•Have received psychosurgery or physical therapy for psychiatric illness (such as transcranial magnetic stimulation) within 3 months prior to screening;
•Have received systematic psychotherapy or other non-drug therapies for psychiatric disorders (such as acupuncture or light therapy) within 6 weeks prior to screening;
•Concomitant with serious and unstable illness, including cardiovascular, hepatic, renal, hematological, endocrine illness, malignant tumors and other physical illness;
•Have a history of seizures (except for seizures caused by febrile convulsions in childhood);
•Have a history of gastrointestinal disease or surgery known to interfere with investigation product absorption or excretion;
•Known or suspected allergic or severe reaction to investigation product or inactive ingredients; or allergic to venlafaxine or desvenlafaxine; or allergic constitution (defined as allergic to two or more drugs or food) and unfit to participate judged by investigator;

Arms & Interventions

Toludesvenlafaxine Hydrochloride Sustained-release Tablets 80 mg group

orally once a day

Intervention: Toludesvenlafaxine Hydrochloride Sustained-release Tablet 80mg

Toludesvenlafaxine Hydrochloride Sustained-release Tablets 160 mg group

orally once a day

Intervention: Toludesvenlafaxine Hydrochloride Sustained-release Tablet 160mg

Placebo

orally once a day

Intervention: placebo

Outcomes

Primary Outcomes

Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale total score at endpoint

Time Frame: from baseline to week 8

The HAMA Scale consist of 14 items that include psychic, somatic, and behavioral symptoms associated with anxiety. Each items is rated on a 5-point scale of 0(not present) to 4(very severe) so that scores may range from 0 to 56, with high scores indicating greater illness severity.

Secondary Outcomes

Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale psychic factor score (Items 1~6 and Item 14) at endpoint(from baseline to week 8)
Percentage of participants with response at endpoint(from baseline to week 8)
Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale somatic factor score (Items 7~13) at endpoint(from baseline to week 8)
Percentage of participants with remission at endpoint(from baseline to week 8)
Change from baseline in Clinical Global Impression Scale - severity (CGI-S) score at endpoint(from baseline to week 8)
Change from baseline in the Columbia Suicide severity Rating Scale (C-SSRS) score at endpoint(from baseline to week 8)
Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale item 1（Anxious mood）Score at endpoint(from baseline to week 8)
Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale item 2（Tension）Score at endpoint(from baseline to week 8)
Clinical Global Impression Scale - improvement (CGI-I) score at endpoint(from baseline to week 8)
Change from baseline in the Sheehan Disability Scale(SDS) score at endpoint(from baseline to week 8)
Change from baseline in the Pittsburgh Sleep Quality Index (PSQI) score at endpoint(from baseline to week 8)
Incidence and severity of adverse effects (AEs)(from baseline to week 8)