A clinical trial to study the effectiveness of the drug ramelteon in patients with difficulty in sleeping (insomnia)

Phase 4

• Conditions: Health Condition 1: null- Insomnia; Depression; Anxiety

• Registration Number: CTRI/2015/02/005530
• Lead Sponsor: Sri Aurobindo Medical College Postgraduate Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

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 (DSM­5).

Ramelteon / Zolpidem prescribed (by psychiatrist).

Written informed consent.

Exclusion Criteria

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Insomnia Severity IndexTimepoint: 2 and 4 weeks

Secondary Outcome Measures

Name	Time	Method
Hamilton Rating Scale for Depression <br/ ><br>Hamilton Rating Scale for AnxietyTimepoint: 2 and 4 weeks