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

NCT05970510 | Recruiting Phase 3

• 1 other identifier: LY03005/CT-CHN-307
• Study Type: interventional
• Target: 555
• Locations: 1 country
• Sites: 1

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.

Conditions

Generalized Anxiety Disorder

Keywords

Toludesvenlafaxine Hydrochloride Sustained-release Tablet; generalized anxiety disorder; efficacy; safety

Outcome Measures

Primary Outcomes (1)

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

  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.

  from baseline to week 8

Secondary Outcomes (12)

• 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

• Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale somatic factor score (Items 7~13) 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

• Percentage of participants with response at endpoint

  from baseline to week 8

Study Arms (3)

Toludesvenlafaxine Hydrochloride Sustained-release Tablets 80 mg group

EXPERIMENTAL

orally once a day

Drug: Toludesvenlafaxine Hydrochloride Sustained-release Tablet 80mg

Toludesvenlafaxine Hydrochloride Sustained-release Tablets 160 mg group

EXPERIMENTAL

orally once a day

Drug: Toludesvenlafaxine Hydrochloride Sustained-release Tablet 160mg

Placebo

SHAM COMPARATOR

orally once a day

Drug: placebo

Interventions

Toludesvenlafaxine Hydrochloride Sustained-release Tablet 80mg DRUG

orally once a day

Toludesvenlafaxine Hydrochloride Sustained-release Tablets 80 mg group

Toludesvenlafaxine Hydrochloride Sustained-release Tablet 160mg DRUG

orally once a day

Toludesvenlafaxine Hydrochloride Sustained-release Tablets 160 mg group

placebo DRUG

orally once a day

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Luye Pharma Group Ltd.: lead

Study Sites (1)

Peking University Sixth Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Zhang Hongyan

  Peking University Sixth Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhang Hongyan

CONTACT

13601237138; hongyanzhang@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 1, 2023
• Study Start: July 12, 2023
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

CN (1)