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

Generalized Anxiety Disorder Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05970510
• Other study ID #: LY03005/CT-CHN-307
• Status: Recruiting
• Phase: Phase 3
• Start date: July 12, 2023
• Est. completion date: April 30, 2026

Study information

• Verified date: March 2024
• Source: Luye Pharma Group Ltd.
• Contact: Zhang Hongyan
• Phone: 13601237138
• Email: hongyanzhang[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 555
• Est. completion date: April 30, 2026
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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;

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

Drug:
• Toludesvenlafaxine Hydrochloride Sustained-release Tablet 80mg
orally once a day
• Toludesvenlafaxine Hydrochloride Sustained-release Tablet 160mg
orally once a day
• placebo
orally once a day

Locations

Country	Name	City	State
China	Peking University Sixth Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Luye Pharma Group Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale psychic factor score (Items 1~6 and Item 14) at endpoint	The psychic factor score is the sum of items 1-6 and items 14(including items such as anxious mood, tension, fear, insomnia, and behavioral symptoms).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 28, with high scores indicating greater illness severity.	from baseline to week 8
Secondary	Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale somatic factor score (Items 7~13) at endpoint	The somatic factor score is the sum of items 7-13(including items such as cardiovascular, respiratory, and gastrointestinal symptoms).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 28, with high scores indicating greater illness severity.	from baseline to week 8
Secondary	Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale item 1(Anxious mood)Score at endpoint	The item is rated on a 5-point scale of 0(not present) to 4(very severe) so that score may range from 0 to 4, with high scores indicating greater illness severity.	from baseline to week 8
Secondary	Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale item 2(Tension)Score at endpoint	The item is rated on a 5-point scale of 0(not present) to 4(very severe) so that score may range from 0 to 4, with high scores indicating greater illness severity.	from baseline to week 8
Secondary	Percentage of participants with response at endpoint	Response was defined as a=50% reduction from baseline to endpoint in the HAMA total score.	from baseline to week 8
Secondary	Percentage of participants with remission at endpoint	Remission was defined as a HAMA total score =7 points at endpoint	from baseline to week 8
Secondary	Clinical Global Impression Scale - improvement (CGI-I) score at endpoint	The CGI-I scale measures the participant's improvement (or worsening) as assessed by the investigator relative to Baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.	from baseline to week 8
Secondary	Change from baseline in Clinical Global Impression Scale - severity (CGI-S) score at endpoint	The CGI-S scale is a 7-point scale to rate the severity of the patient's illness. Patient is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.	from baseline to week 8
Secondary	Change from baseline in the Sheehan Disability Scale(SDS) score at endpoint	The SDS scale consists of 3 items evaluating impairment in work/school, social life/leisure activities, and family life/home responsibilities. Each item is scored on a scale of 0(unimpaired) to 10(highly impaired).	from baseline to week 8
Secondary	Change from baseline in the Pittsburgh Sleep Quality Index (PSQI) score at endpoint	The scale consists of 3 items evaluating impairment in work/school, social life/leisure activities, and family life/home responsibilities. Each item is scored on a scale of 0(unimpaired) to 10(highly impaired).	from baseline to week 8
Secondary	Incidence and severity of adverse effects (AEs)		from baseline to week 8
Secondary	Change from baseline in the Columbia Suicide severity Rating Scale (C-SSRS) score at endpoint	The C-SSRS captured the occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation: a "yes" answer to any 1 of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Suicidal behavior: a "yes" answer to any 1 of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide.	from baseline to week 8