Effect of Slow-release Melatonin (Circadin®) Therapy on Idiopathic RBD: a Pilot Study
NCT ID: NCT02836743
Last Updated: 2017-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
30 participants
INTERVENTIONAL
2016-01-31
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Circadin 2mg
low-dose (2mg) slow-release melatonin for 1 month.
Circadin
Slow-release melatonin
Circadin 6mg
high-dose (6mg) slow-release melatonin for 1 month.
Circadin
Slow-release melatonin
Placebo
Administer placebo pills with identical morphology
Placebo
Interventions
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Circadin
Slow-release melatonin
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No cognitive deficit or symptom of Parkinsonism
* Those with written consent.
Exclusion Criteria
* 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.)
18 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Ki-Young Jung
Professor
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
Other Identifiers
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1505-084-673
Identifier Type: -
Identifier Source: org_study_id
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