Preclinical in vivo evaluation of ramelteon for central nervous system activities and a clinical observational study of its efficacy in patients with insomnia

Sri Aurobindo Medical College Postgraduate Institute0 个研究点目标入组 120 人开始时间: 待定最近更新: 2021年11月24日

适应症

试验速览

暂无简介。

•Patients of either sex, aged 18 to 65 years, suffering from insomnia.
•Primary or secondary insomnia with anxiety disorder or depression(diagnosed by psychiatrist) as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSMÂ5).
•Ramelteon / Zolpidem prescribed (by psychiatrist).
•Written informed consent.

•Patients with hypersensitivity to ramelteon, melatonin or zolpidem.
•Patients having sleep schedule changes required by employment e.g., shift workers.
•Patients with major depressive, psychotic or bipolar disorder with significant suicide risk.
•Patients with substance dependence/ abuse.
•Patients receiving any medication known to affect sleep.
•Clinically significant deviations from normal in medical history (apart from insomnia and psychiatric comorbid conditions such as anxiety disorders or depression), vital signs, physical examination, and laboratory evaluations.

发起方

Sri Aurobindo Medical College Postgraduate Institute