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

Inclusion Criteria5

  • 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 Criteria10

  • 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;

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

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NCT05970510


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