NCT05970510已完成3 期
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.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 555
- 试验地点
- 2
- 主要终点
- Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale total score at endpoint
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
研究组 & 干预措施
Placebo
Sham Comparator
orally once a day
干预措施: placebo (Drug)
Toludesvenlafaxine Hydrochloride Sustained-release Tablets 160 mg group
Experimental
orally once a day
干预措施: Toludesvenlafaxine Hydrochloride Sustained-release Tablet 160mg (Drug)
Toludesvenlafaxine Hydrochloride Sustained-release Tablets 80 mg group
Experimental
orally once a day
干预措施: Toludesvenlafaxine Hydrochloride Sustained-release Tablet 80mg (Drug)
结局指标
主要结局
Change from baseline in the Hamilton Anxiety(HAMA) Rating Scale total score at endpoint
时间窗: 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.
次要结局
- 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)
- Percentage of participants with response 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)
- Percentage of participants with remission at endpoint(from baseline to week 8)
- Change from baseline in Clinical Global Impression Scale - severity (CGI-S) score at endpoint(from baseline to week 8)
- Change from baseline in the Columbia Suicide severity Rating Scale (C-SSRS) score 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)
- Clinical Global Impression Scale - improvement (CGI-I) score at endpoint(from baseline to week 8)
- Change from baseline in the Sheehan Disability Scale(SDS) score at endpoint(from baseline to week 8)
- Change from baseline in the Pittsburgh Sleep Quality Index (PSQI) score at endpoint(from baseline to week 8)
- Incidence and severity of adverse effects (AEs)(from baseline to week 8)
研究者
研究点 (2)
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