Clinical trial NCT05970510: A Study to Evaluate Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets in Generalized Anxiety Disorder.
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Generalized Anxiety Disorder
Keywords: Toludesvenlafaxine Hydrochloride Sustained-release Tablet
generalized anxiety disorder
efficacy
safety
Lead sponsor: Luye Pharma Group Ltd.
Sponsor class: INDUSTRY
First posted: 2023-08-01
Enrollment: 555
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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;

Primary outcomes:
measure: Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale total score at endpoint
timeFrame: from baseline to week 8
Secondary outcomes:
measure: Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale psychic factor score (Items 1~6 and Item 14) at endpoint
timeFrame: from baseline to week 8
measure: Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale somatic factor score (Items 7~13) at endpoint
timeFrame: from baseline to week 8
measure: Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale item 1（Anxious mood）Score at endpoint
timeFrame: from baseline to week 8
measure: Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale item 2（Tension）Score at endpoint
timeFrame: from baseline to week 8
measure: Percentage of participants with response at endpoint
timeFrame: from baseline to week 8
measure: Percentage of participants with remission at endpoint
timeFrame: from baseline to week 8
measure: Clinical Global Impression Scale - improvement (CGI-I) score at endpoint
timeFrame: from baseline to week 8
measure: Change from baseline in Clinical Global Impression Scale - severity (CGI-S) score at endpoint
timeFrame: from baseline to week 8
measure: Change from baseline in the Sheehan Disability Scale(SDS) score at endpoint
timeFrame: from baseline to week 8
measure: Change from baseline in the Pittsburgh Sleep Quality Index (PSQI) score at endpoint
timeFrame: from baseline to week 8
measure: Incidence and severity of adverse effects (AEs)
timeFrame: from baseline to week 8
measure: Change from baseline in the Columbia Suicide severity Rating Scale (C-SSRS) score at endpoint
timeFrame: from baseline to week 8
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Sixth Hospital
Study officials:
affiliation: Peking University Sixth Hospital
name: Zhang Hongyan
role: PRINCIPAL_INVESTIGATOR
References: