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The Study of Combination Use of Melatonin Receptor Agonist for Dose Reduction or Interruptions of Benzodiazepine (BZD) and Non-BZD Hypnotics on Chronic Insomnia — BRED  

Chronic Insomnia Clinical Trial

Official title:
The Placebo Controlled Randomized Double Blind Multicenter Study to Investigate Effectiveness and Safety of Combination Use of Melatonin Receptor Agonist for Dose Reduction or Interruptions of BZD and Non-BZD Hypnotics on Chronic Insomnia

Clinical Trial Summary

To investigate effects on combination use of Ramelteon in the dose reduction or interruption process of (non-)BZD hypnotics during the dose reduction or interruption algorithm.

Clinical Trial Description

The hypnotic 'Ramelteon' does not have effect on Gamma Aminobutyric Acid (GABA-A) receptor that relates to the formation of addiction to the BZD or non-BZD hypnotics. Some results of clinical trials has been reported that the dose reduction or interruption of (non-)BZD hypnotics was achieved on combination use of Ramelteon by using its characteristic of the action mechanism with safely and effectively. However, these results have not been confirmed with randomized controlled trials. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03461042
Study type Interventional
Source Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Contact
Status Completed
Phase Phase 4
Start date February 6, 2018
Completion date March 16, 2020
View Details
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