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

Phase 3

Recruiting

• Conditions: Generalized Anxiety Disorder
• Interventions: Drug: placebo; Drug: Toludesvenlafaxine Hydrochloride Sustained-release Tablet 80mg; Drug: Toludesvenlafaxine Hydrochloride Sustained-release Tablet 160mg

• Registration Number: NCT05970510
• Lead Sponsor: Luye Pharma Group Ltd.

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.

Study Timeline

• Study Start: 2023-07-12
• Study First Submitted: 2023-07-24
• Study First Submitted QC: 2023-07-24
• Study First Posted: 2023-08-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-15
• Primary Completion: 2026-04-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 555

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	orally once a day
Toludesvenlafaxine Hydrochloride Sustained-release Tablets 80 mg group	Toludesvenlafaxine Hydrochloride Sustained-release Tablet 80mg	orally once a day
Toludesvenlafaxine Hydrochloride Sustained-release Tablets 160 mg group	Toludesvenlafaxine Hydrochloride Sustained-release Tablet 160mg	orally once a day

Primary Outcome Measures

Name	Time	Method
Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale total score at endpoint	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 Outcome Measures

Name	Time	Method
Incidence and severity of adverse effects (AEs)	from baseline to week 8
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	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.
Percentage of participants with response at endpoint	from baseline to week 8	Response was defined as a≥50% reduction from baseline to endpoint in the HAMA total score.
Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale somatic factor score (Items 7~13) at endpoint	from baseline to week 8	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.
Percentage of participants with remission at endpoint	from baseline to week 8	Remission was defined as a HAMA total score ≤7 points at endpoint
Change from baseline in Clinical Global Impression Scale - severity (CGI-S) score at endpoint	from baseline to week 8	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.
Change from baseline in the Columbia Suicide severity Rating Scale (C-SSRS) score at endpoint	from baseline to week 8	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.
Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale item 1（Anxious mood）Score at endpoint	from baseline to week 8	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.
Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale item 2（Tension）Score at endpoint	from baseline to week 8	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.
Clinical Global Impression Scale - improvement (CGI-I) score at endpoint	from baseline to week 8	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.
Change from baseline in the Sheehan Disability Scale(SDS) score at endpoint	from baseline to week 8	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).
Change from baseline in the Pittsburgh Sleep Quality Index (PSQI) score at endpoint	from baseline to week 8	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).

Trial Locations

Locations (1)

Peking University Sixth Hospital; 🇨🇳 Beijing, China