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Chronic InsomniaPhase 4BREDNCT03461042

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

A Phase 4 study testing Ramelteon 8mg in people with Chronic Insomnia, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Chronic Insomnia
What is being tested?
Ramelteon 8mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
17 participants
Where
1 siteJapan
Study dates
6 Feb 2018to 16 Mar 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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)
  • Patients taking 2 drugs at 2-fold of the usual dose (2 units) Patients whose total dosage are 2～4 units of 1～4 drugs can be also included. But attention needed not to conflict with exclusion criteria 2.
  • ※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.

Who cannot join

  • 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
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  • 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
  • Patients in whom the dose of psychotropics except for the items 2～7 were changed within 1 month prior to the informed consent
  • Patients who are comorbid with depression or bipolar disordered and in whom depressive symptoms have not remitted
  • Patients in whom frequency in Q9 of PHQ "thoughts that you would be better off dead or thoughts of hurting yourself in some way" is "more than half the days (in the past 2 weeks)" or the total score is 10 or higher
  • Patients with dementia, schizophrenia, drug dependence and alcoholic
  • Patients with liver/kidney disorder, female subjects who are pregnant or in breast-feeding, and malignant neoplasm
  • Night workers
  • Patients meeting contraindications for ramelteon
  • Other patients judged ineligible for participation in the study by the investigator

Trial locations and contacts

1 site in 1 country.

Japan1 site

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

    Shibuya-ku, Tokyo, 151-0053

Other trials in Japan

About this study

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

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.

Read the detailed 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.

Being tested
Ramelteon 8mg, Placebo
Keywords
Chronic insomnia, Ramelteon, Rozerem, dose reduction
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ramelteon 8mgDrug

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

  • PlaceboDrug

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

Study groups in NCT03461042
Study groupRoleWhat they receive
Arm RExperimentalCo-administer following medication for 12 weeks since informed consent; R group: taking capsule of Ramelteon 8mg once daily before sleeping.
Receives: Drug: Ramelteon 8mg
Arm PLPlacebo comparatorCo-administer following medication for 12 weeks since informed consent; Placebo group: taking capsule of Placebo once daily before bedtime.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12 weeks

  2. 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

    Measured: 12 weeks

Secondary outcomes (10)

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

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

    Measured: at 4 weeks and 8weeks

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

    The average of the dose reduction rate will be assessed by Participant's diary

    Measured: at 4 weeks, 8weeks and 12 weeks

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

    The achievement ratio of the 100% dose reduction will be assessed by Participant's diary

    Measured: 12 weeks

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

    The variation in total score of PSQI will be assessed by the PSQI value sets sets at week 0, 4, 8 and 12. (The range of total score is 0-21. Higher scores represent worse tendency of the symptoms.)

    Measured: at 0, 4, 8 and 12 weeks

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

    The variation in total score of AIS will be assessed by the AIS value sets at week 0, 4, 8 and 12. (The range of total score is 0-24. Higher scores represent worse tendency of the symptoms.)

    Measured: at 0, 4, 8 and 12 weeks

  6. The variation in Patient health questionnaire (PHQ-9) score at 4weeks, 8weeks and 12weeks

    The variation in PHQ-9 score will be assessed by the PHQ-9 value sets at week 0, 4, 8 and 12. (The range of total score is 0-27. Higher scores represent worse tendency of the symptoms.)

    Measured: at 0, 4, 8 and 12 weeks

  7. Guide to the use of the clinical withdrawal assessment scale for benzodiazepines (CIWA-B) score at 4weeks, 8weeks and 12weeks

    The variation in CIWA-B (Guide to the use of the clinical withdrawal assessment scale for benzodiazepines) score will be assessed by the CIWA-B value sets at week 4, 8 and 12. (The range of total score is 0-80. Higher scores represent worse tendency of the symptoms.)

    Measured: at 4, 8 and 12 weeks

  8. Patient global impression of therapy (PGI) score at 12weeks or withdrawal

    PGI(Patient global impression of therapy) score will be assessed by the PGI value sets at 12weeks or withdrawal. (The range of total score is 0-21. Higher scores represent worse tendency of the symptoms.)

    Measured: 12 weeks

  9. The variation in Ben-dep(Benzodiazepine Dependence Self-Report Questionnaire) score at 12weeks or withdrawal

    The variation in Ben-dep score will be assessed by the Ben-dep value sets at 0 and 12weeks or withdrawal. (The range of total score is 0-100. Higher scores represent worse tendency of the symptoms.)

    Measured: at 0 and 12 weeks

  10. Adverse Events

    Adverse Events will be determined by the latest version of MedDRA/J （Medical Dictionary for Regulatory Activities/J).

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2018
  2. Study start6 Feb 2018
  3. Primary completion31 Jul 2019
  4. Study completion16 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03461042
Sponsor's protocol ID
293/CR1-003 / TRIPSYCHI1407
Acronym
BRED
Status last verified
Jan 2021
First submitted
14 Feb 2018
Last updated
20 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ramelteon 8mg in people with Chronic Insomnia, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03461042.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.

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