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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

NCT03461042 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2024-11-20

No results posted yet for this study

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.

Conditions

  • Chronic Insomnia

Interventions

DRUG

Ramelteon 8mg

Ramelteon 8mg once daily before bedtime for 12 weeks since informed consent

DRUG

Placebo

Placebo capsule once daily before bedtime for 12 weeks since informed consent

Sponsors & Collaborators

  • Yoyogi Sleep Disorder Clinic, Foundation of Sleep and Health Science

    collaborator UNKNOWN

  • Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

    lead OTHER

Principal Investigators

  • Yuichi Inoue, MD, Ph.D. · Yoyoghi Sleep Disorder Clinic / Foundation of Sleep and Health Science

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-06
Primary Completion
2019-07-31
Completion
2020-03-16

Countries

  • Japan

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03461042 on ClinicalTrials.gov