跳至主要内容
临床试验/CTRI/2024/04/066458
CTRI/2024/04/066458尚未招募4 期

A comparative study to assess the efficacy and safety of Vortioxetine versus sertraline in patients suffering from Anxiety Disorder

Mitsha Nagpal1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年5月20日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
120
试验地点
1
主要终点
Vortioxetine will be more efficacious on symptom severity in patients suffering from Anxiety Disorder compared to Sertraline.

研究概览

简要总结

Generalized anxiety disorder (GAD) is prevalent (12-month and lifetime prevalence of 3.1 and 5.1%, respectively) and associated with significant impairment in psychosocial functioning, including work functioning. It is a persistent condition characterized by chronic anxiety, exaggerated worry and tension, mainly comorbid with Major Depressive Disorder (MDD).  It includes excessive, uncontrollable and often irrational worry, that is, apprehensive expectation about events or activities. This excessive worry often interferes with daily functioning. A condition marked by excessive worry and feelings of fear, dread, and uneasiness that last six months or longer. Other symptoms of GAD include being restless, being tired or irritable, muscle tension, not being able to concentrate or sleep well, shortness of breath, fast heartbeat, sweating, and dizziness. currently, selective serotonin reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors are recommended as first-line treatment of GAD. However, some patients may not respond to the treatment or discontinue due to adverse effects. Vortioxetine (VRX) is a multimodal antidepressant with a unique mechanism of action, by acting as 5-HT3A, 5-HT1D and 5-HT7 receptor antagonist, partial agonist at the 5-HT1A and 5-HT1B receptors and inhibitor at the 5-HT transporter. Sertraline is a naphthalenamine derivative with the predominant pharmacological action of inhibiting presynaptic reuptake of serotonin from the synaptic cleft. It was initially marketed for the treatment of major depressive disorder and is now approved for the management of panic disorder, obsessive-compulsive disorder and post-traumatic stress disorder.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Both male and female patients aged between 18 and 60 years.
  • Those giving written consent/guardians giving written consent (in cases where the patients were too ill to understand the process of informed consent and give an informed choice.)
  • People diagnosed with anxiety disorder as per ICD-10 diagnostic criteria.
  • HAM-A score ≥18.

排除标准

  • Systemic or Neurological Disorder affecting Cognition, Behavior or Mental Status.
  • Substance dependence except for Nicotine and Caffeine within the past month of entering the study.
  • Long-standing medical or surgical illnesses.
  • Patients with mental retardation or organic brain disorders.
  • Patients suffering from neurological, metabolic and vascular conditions affecting sexual function.

结局指标

主要结局

Vortioxetine will be more efficacious on symptom severity in patients suffering from Anxiety Disorder compared to Sertraline.

时间窗: At the end of 4 weeks and 8 weeks.

次要结局

  • Vortioxetine and Sertraline will have similar effects on cognitive functioning.(At the end of 4 weeks and 8 weeks.)
  • Vortioxetine will be safer as compared to Sertraline in sexual functioning.(At the end of 4 weeks and 8 weeks.)
  • Vortioxetine and Sertraline will have similar side effects.(At the end of 4 weeks and 8 weeks.)

研究者

发起方
Mitsha Nagpal
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Jitendriya Biswal

IMS & SUM Hospital

研究点 (1)

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