Back to resultsEffect of Slow-release Melatonin (Circadin®) Therapy on Idiopathic RBD: a Pilot Study
Primary Purpose
REM Sleep Behavior Disorder
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Circadin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for REM Sleep Behavior Disorder focused on measuring REM sleep behavior disorder, Melatonin
Eligibility 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.)
Sites / Locations
- Seoul National University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Circadin 2mg
Circadin 6mg
Placebo
Arm Description
low-dose (2mg) slow-release melatonin for 1 month.
high-dose (6mg) slow-release melatonin for 1 month.
Administer placebo pills with identical morphology
Outcomes
Primary Outcome Measures
Changes in Clinical Global Impression scale
Changes in RBDQ-HK score (RBD questionnaire-HK)
Secondary Outcome Measures
Sleep quality questionnaire
PSQI
Sleepiness questionnaire
Epworth sleepiness scale
Quality of life questionnaire
SF-36 version 2.
Changes in Dream enactment behavior frequency described in sleep diary
Drug adverse effect
adverse events and reason for drug withdrawal
Full Information
NCT ID
NCT02836743
First Posted
July 13, 2016
Last Updated
April 26, 2017
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02836743
Brief Title
Effect of Slow-release Melatonin (Circadin®) Therapy on Idiopathic RBD: a Pilot Study
Official Title
Effect of Slow-release Melatonin (Circadin®) Therapy on Idiopathic REM Sleep Behavior Disorder: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 31, 2017 (Anticipated)
Study Completion Date
December 31, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate effect of slow-release melatonin (Circadin) on REM sleep behavior disorder.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
REM Sleep Behavior Disorder
Keywords
REM sleep behavior disorder, Melatonin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Circadin 2mg
Arm Type
Experimental
Arm Description
low-dose (2mg) slow-release melatonin for 1 month.
Arm Title
Circadin 6mg
Arm Type
Experimental
Arm Description
high-dose (6mg) slow-release melatonin for 1 month.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Administer placebo pills with identical morphology
Intervention Type
Drug
Intervention Name(s)
Circadin
Other Intervention Name(s)
slow-release melatonin
Intervention Description
Slow-release melatonin
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Changes in Clinical Global Impression scale
Time Frame
baseline and 4 weeks
Title
Changes in RBDQ-HK score (RBD questionnaire-HK)
Time Frame
Baseline and 4 weeks
Secondary Outcome Measure Information:
Title
Sleep quality questionnaire
Description
PSQI
Time Frame
after taking the treatment for 4 weeks
Title
Sleepiness questionnaire
Description
Epworth sleepiness scale
Time Frame
after taking the treatment for 4 weeks
Title
Quality of life questionnaire
Description
SF-36 version 2.
Time Frame
after taking the treatment for 4 weeks
Title
Changes in Dream enactment behavior frequency described in sleep diary
Time Frame
Baseline and 4 weeks
Title
Drug adverse effect
Description
adverse events and reason for drug withdrawal
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ki-Young Jung, M.D. Ph.D.
Phone
+82-2-2072-4988
Email
jungky10@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jung-Ick Byun, M.D.
Phone
+82-2-440-6254
Email
mr830611@gmail.com
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ki-Young Jung, professor
Phone
+82-2-2072-0694
Email
jungky10@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
11422870
Citation
Takeuchi N, Uchimura N, Hashizume Y, Mukai M, Etoh Y, Yamamoto K, Kotorii T, Ohshima H, Ohshima M, Maeda H. Melatonin therapy for REM sleep behavior disorder. Psychiatry Clin Neurosci. 2001 Jun;55(3):267-9. doi: 10.1046/j.1440-1819.2001.00854.x.
Results Reference
background
PubMed Identifier
10348479
Citation
Kunz D, Bes F. Melatonin as a therapy in REM sleep behavior disorder patients: an open-labeled pilot study on the possible influence of melatonin on REM-sleep regulation. Mov Disord. 1999 May;14(3):507-11. doi: 10.1002/1531-8257(199905)14:33.0.co;2-8.
Results Reference
background
PubMed Identifier
14592300
Citation
Boeve BF, Silber MH, Ferman TJ. Melatonin for treatment of REM sleep behavior disorder in neurologic disorders: results in 14 patients. Sleep Med. 2003 Jul;4(4):281-4. doi: 10.1016/s1389-9457(03)00072-8.
Results Reference
background
PubMed Identifier
20561180
Citation
Kunz D, Mahlberg R. A two-part, double-blind, placebo-controlled trial of exogenous melatonin in REM sleep behaviour disorder. J Sleep Res. 2010 Dec;19(4):591-6. doi: 10.1111/j.1365-2869.2010.00848.x.
Results Reference
background
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Effect of Slow-release Melatonin (Circadin®) Therapy on Idiopathic RBD: a Pilot Study
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