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临床试验/CTRI/2025/08/092417
CTRI/2025/08/092417尚未招募不适用

A comparison of the anxiolytic properties of Tofisopam and Clonazepam—A randomized controlled study

Kurma Ramya Krishna1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年8月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Changes in scores of the Hamilton Anxiety Rating Scale

研究概览

简要总结

Anxiety acts as an alerting signal. It is characterized by a diffuse, unpleasant, and vague sense of apprehension, often accompanied by autonomic symptoms such as headache, perspiration, palpitations, chest tightness, stomach discomfort, and restlessness. These symptoms tend to vary among persons. Anxiety disorders are among the most prevalent psychiatric conditions. It is also the leading cause of distress and impairment. This group includes clinically related but distinct mental disorders. It includes panic disorder, phobias, social anxiety disorder, and generalized anxiety disorder. Clonazepam and etizolam are established as anxiolytic agents. Tofisopam was approved over 35 years ago and was recently launched in India. It is efficacious compared to other benzodiazepines in treating anxiety disorders. It was found to have significant anxiolytic effects with no impairment of attention or somnolence and was well tolerated with no adverse effects. The clinical effect of tofisopam is evident as early as 1 week, with a maximum response by 3 weeks, at a dose of 150 to 300 mg/day. This would prove to be a game-changer in the treatment of anxiety disorders. Data exists on the clinical effectiveness of Tofisopam in anxiety disorders, but there is a lack of research on the direct comparison of Tofisopam with other established benzodiazepines in patients with anxiety disorders. We intend to explore this aspect and find out whether, in comparison with Clonazepam, Tofisopam is effective and has a better side effect profile. This can have more clinical implications for the use of tofisopam clinically.

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

  • Patients who are diagnosed with any anxiety disorder according to the International Classification of Diseases (ICD-11).
  • This includes the diagnosis of phobias, panic disorders, and generalized anxiety disorder.
  • Past diagnosis of mental illness, but not on medication for at least 3 months.

排除标准

  • Organic causes for the anxiety symptoms.
  • Presence of uncontrolled medical conditions such as hypertension, diabetes mellitus, bronchial asthma, etc.
  • Presence of severe medical conditions that might interfere with assessment, such as cancer, renal problems, cardiac problems, etc.
  • Pregnancy
  • Unwilling to participate in the study.

结局指标

主要结局

Changes in scores of the Hamilton Anxiety Rating Scale

时间窗: Changes in scores of the Hamilton Anxiety Rating Scale at baseline, 2 weeks, and 4 weeks.

次要结局

  • To compare the tolerability between the two anxiolytics by a generic assessment of the Side Effects scale.(Baseline, 2 weeks, and 4 weeks.)

研究者

发起方
Kurma Ramya Krishna
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Kurma Ramya Krishna

Konaseema Institute of Medical Sciences and Reseach foundation

研究点 (1)

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