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Effect of Slow-release Melatonin (Circadin®) Therapy on Idiopathic RBD: a Pilot Study

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ClinicalTrials.gov Identifier: NCT02836743
Recruitment Status : Unknown
Verified April 2017 by Ki-Young Jung, Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : July 19, 2016
Last Update Posted : April 28, 2017
Sponsor:
Information provided by (Responsible Party):
Ki-Young Jung, Seoul National University Hospital

Brief Summary:
To evaluate effect of slow-release melatonin (Circadin) on REM sleep behavior disorder.

Condition or disease Intervention/treatment Phase
REM Sleep Behavior Disorder Drug: Circadin Drug: Placebo Phase 4

Detailed Description:
Investigators planned to administer low (2mg) and high (6mg) dose slow-release melatonin and the placebo for 4 weeks and evaluate Clinical Global Impression scale, RBD questionnaire, PSQI, Epworth sleepiness scale, and quality of life questionnaire (SF-36v2) before and after the treatment along with possible side effects and drug compliance.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Slow-release Melatonin (Circadin®) Therapy on Idiopathic REM Sleep Behavior Disorder: a Pilot Study
Study Start Date : January 2016
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arm Intervention/treatment
Experimental: Circadin 2mg
low-dose (2mg) slow-release melatonin for 1 month.
Drug: Circadin
Slow-release melatonin
Other Name: slow-release melatonin

Experimental: Circadin 6mg
high-dose (6mg) slow-release melatonin for 1 month.
Drug: Circadin
Slow-release melatonin
Other Name: slow-release melatonin

Placebo Comparator: Placebo
Administer placebo pills with identical morphology
Drug: Placebo



Primary Outcome Measures :
  1. Changes in Clinical Global Impression scale [ Time Frame: baseline and 4 weeks ]
  2. Changes in RBDQ-HK score (RBD questionnaire-HK) [ Time Frame: Baseline and 4 weeks ]

Secondary Outcome Measures :
  1. Sleep quality questionnaire [ Time Frame: after taking the treatment for 4 weeks ]
    PSQI

  2. Sleepiness questionnaire [ Time Frame: after taking the treatment for 4 weeks ]
    Epworth sleepiness scale

  3. Quality of life questionnaire [ Time Frame: after taking the treatment for 4 weeks ]
    SF-36 version 2.

  4. Changes in Dream enactment behavior frequency described in sleep diary [ Time Frame: Baseline and 4 weeks ]
  5. Drug adverse effect [ Time Frame: 4 weeks ]
    adverse events and reason for drug withdrawal



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • REM sleep behavior disorder according to ICSD-3 criteria
  • No cognitive deficit or symptom of Parkinsonism
  • Those with written consent.

Exclusion Criteria:

  • who took medication (ex. clonazepam) for REM sleep behavior disorder
  • with degenerative neurologic disorder (ex. Parkinson's disease, Multiple System Atrophy, Lewy-body dementia, etc.)
  • who took medication that can affect REM sleep behavior disorder (anti-depressant: SSRI, TCA, MAO-inhibitor)
  • who is unable to answer questionnaires
  • who have hypersensitive reaction to medications
  • Pregnant women or breastfeeding
  • who are diagnosed with other parasomnia disorder
  • with severe medical disorder (severe liver failure, respiratory failure, heart failure, malignant tumor, etc.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836743


Contacts
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Contact: Ki-Young Jung, M.D. Ph.D. +82-2-2072-4988 jungky10@gmail.com
Contact: Jung-Ick Byun, M.D. +82-2-440-6254 mr830611@gmail.com

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Ki-Young Jung, professor    +82-2-2072-0694    jungky10@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital

Publications:
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Responsible Party: Ki-Young Jung, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02836743    
Other Study ID Numbers: 1505-084-673
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Ki-Young Jung, Seoul National University Hospital:
REM sleep behavior disorder
Melatonin
Additional relevant MeSH terms:
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Melatonin
REM Sleep Behavior Disorder
Mental Disorders
REM Sleep Parasomnias
Parasomnias
Sleep Wake Disorders
Nervous System Diseases
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants