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

NCT ID: NCT05970510

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 555 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-12
• Study Completion Date: 2026-04-30

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.

Conditions

Generalized Anxiety Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Toludesvenlafaxine Hydrochloride Sustained-release Tablets 80 mg group

orally once a day

Group Type: EXPERIMENTAL

Toludesvenlafaxine Hydrochloride Sustained-release Tablet 80mg

Intervention Type: DRUG

orally once a day

Toludesvenlafaxine Hydrochloride Sustained-release Tablets 160 mg group

orally once a day

Group Type: EXPERIMENTAL

Toludesvenlafaxine Hydrochloride Sustained-release Tablet 160mg

Intervention Type: DRUG

orally once a day

Placebo

orally once a day

Group Type: SHAM_COMPARATOR

placebo

Intervention Type: DRUG

orally once a day

Interventions

Toludesvenlafaxine Hydrochloride Sustained-release Tablet 80mg

orally once a day

Intervention Type: DRUG

Toludesvenlafaxine Hydrochloride Sustained-release Tablet 160mg

orally once a day

Intervention Type: DRUG

placebo

orally once a day

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female aged 18 to 65 years subjects;

2. Meet the Diagnostic and Statistical Manual of Manual Disorders, fifth Edition(DSM-5) criteria for Generalized Anxiety Disorder;

3. Have a Hamilton Anxiety(HAMA) Rating Scale total score ≥21 points at screening and baseline;

4. Have a Hamilton Anxiety(HAMA) Rating Scale score ≥2 points on both item 1(anxious mood) and item 2(tension) at screening and baseline;

5. Have a clinical Global Impression -severity illness (CGI-S) score≥4 points at screening and baseline.

Exclusion Criteria

1. 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;

2. Meet the diagnostic criteria for substance or alcohol abuse (defined by DSM-5, except for nicotine or caffeine) within 6 months prior to screening;

3. Have anxious symtoms secondary to other physical illnesses or mental illnesses and anxious induced by psychoactive substance;

4. 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;

5. Have received psychosurgery or physical therapy for psychiatric illness (such as transcranial magnetic stimulation) within 3 months prior to screening;

6. Have received systematic psychotherapy or other non-drug therapies for psychiatric disorders (such as acupuncture or light therapy) within 6 weeks prior to screening;

7. Concomitant with serious and unstable illness, including cardiovascular, hepatic, renal, hematological, endocrine illness, malignant tumors and other physical illness;

8. Have a history of seizures (except for seizures caused by febrile convulsions in childhood);

9. Have a history of gastrointestinal disease or surgery known to interfere with investigation product absorption or excretion;

10. 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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Luye Pharma Group Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhang Hongyan

Role: PRINCIPAL_INVESTIGATOR

Peking University Sixth Hospital

Locations

Peking University Sixth Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhang Hongyan

Role: CONTACT

hongyanzhang@bjmu.edu.cn

13601237138

Other Identifiers

LY03005/CT-CHN-307

Identifier Type: -

Identifier Source: org_study_id