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 | Completed Phase 4 DMC

• 1 other identifier: 293/CR1-003 / TRIPSYCHI1407
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Chronic insomnia; Ramelteon; Rozerem; dose reduction

Outcome Measures

Primary Outcomes (2)

• The achievement ratio of the 50% dose reduction of (non-)BZD hypnotics (Diazepam conversion value) at 12weeks or withdrawal without any deterioration of insomnia symptoms.

  Evaluate the achievement ratio of the 50% or more of dose reduction by Participant's diary

  12 weeks

• The rate of subjects who achieved more than 50% dose reduction of (non-)BZD hypnotics (Diazepam conversion value) at 12 weeks or withdrawal since informed consent.

  The rate of subjects who achieved more than 50% of dose reduction (Diazepam conversion value) will be assessed by Participant's diary

  12 weeks

Secondary Outcomes (10)

• The achievement ratio of the 50% dose reduction (Diazepam conversion value) at 4weeks and 8weeks

  at 4 weeks and 8weeks

• The average of the dose reduction rate at 4weeks, 8weeks and 12weeks

  at 4 weeks, 8weeks and 12 weeks

• The achievement ratio of the 100% dose reduction at 12weeks or withdrawal

  12 weeks

• The variation in total score of Pittsburg Sleep Quality Index (PSQI) at 4weeks, 8weeks and 12weeks

  at 0, 4, 8 and 12 weeks

• The variation in total score of Athens Insomnia Scale (AIS) at 4weeks, 8weeks and 12weeks

  at 0, 4, 8 and 12 weeks

Study Arms (2)

Arm R

EXPERIMENTAL

Co-administer following medication for 12 weeks since informed consent; R group: taking capsule of Ramelteon 8mg once daily before sleeping.

Drug: Ramelteon 8mg

Arm PL

PLACEBO COMPARATOR

Co-administer following medication for 12 weeks since informed consent; Placebo group: taking capsule of Placebo once daily before bedtime.

Drug: Placebo

Interventions

Ramelteon 8mg DRUG

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

Arm R

Placebo DRUG

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

Arm PL

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects meeting Criteria 1 or 2 and Criteria 3 and all subsequent criteria will be included in the study:
• Patients diagnosed as chronic insomnia having sleep onset disturbance, and with a duration of the disease of at least 6 months
• Patients diagnosed with chronic insomnia comorbid with mood disorders (depression or bipolar disorder) can be included to this study if they have remission of mood symptoms.
• Patients taking (non-)BZD hypnotics (including etizolam at bedtime) at a fixed dose in the following patterns since at least 1 month prior to consent (over 90% of drug compliance should be confirmed at the time of medical interview):
• Patients taking 2 drugs at the usual dose (1 unit)
• Patients taking 3 drugs at the usual dose (1 unit)
• Patients taking 4 drugs at the usual dose (1 unit)
• Patients taking a drug at 2-fold of the usual dose (2 units)
• Patients taking a drug at 2-fold of the usual dose (2 units) and a drug at the usual dose (1 unit)
• Patients taking a drug at 2-fold of the usual dose (2 units) and 2 drugs at the usual dose (1 unit)

You may not qualify if:

• ※Dosage cannot exceeded 2 units per 1 drug.
• Patients whose symptoms of insomnia were stabilized, and the investigators determined that the (non-) BZD hypnotics could be reduced or discontinued
• Patients aged 20 years or older at the time of consent
• Patients who are willing to comply with algorithm for dose reduction and discontinuation
• Patients who can understand the content of the study and provide consent to participate in the study in writing on their own will.
• Subjects meeting any of the following criteria will not be included in the study:
• Patients with secondary insomnia
• Patients taking (non-)BZD hypnotics at a dose exceeding 2-fold of the usual dose
• Patients taking barbiturate and non-barbiturate hypnotics and Suvorexant.
• Patients taking hypnotics other than medicinal pharmaceuticals (including Over The Counter (OTC), supplements believed to be effective for insomnia and melatonin )
• Patients taking mianserin hydrochloride, mirtazapine, and trazodone hydrochloride
• Patients taking antipsychotics
• Patients taking anxiolytic or clonazepam at bedtime
• \*Patient taking anxiolytic and/or clonazepam at times except for bed-time will be included in the study. However, dosage and timing of administration can not be changed during the study period.
• Patients who took ramelteon within 1 month prior to the informed consent

Sponsors & Collaborators

• Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan: lead
• Yoyogi Sleep Disorder Clinic, Foundation of Sleep and Health Science: collaborator

Study Sites (1)

Yoyogi Sleep Disorder Clinic, Foundation of Sleep and Health Science

Shibuya-ku, Tokyo, 151-0053, Japan

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

ramelteon

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Yuichi Inoue, MD, Ph.D.

  Yoyoghi Sleep Disorder Clinic / Foundation of Sleep and Health Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2018
• First Posted: March 9, 2018
• Study Start: February 6, 2018
• Primary Completion: July 31, 2019
• Study Completion: March 16, 2020
• Last Updated: November 20, 2024

Record last verified: 2021-01

Locations

JP (1)