Efficacy and Safety of Melatonin and Clonazepam for IRBD
NCT ID: NCT03255642
Last Updated: 2021-02-21
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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COMPLETED
NA
34 participants
INTERVENTIONAL
2017-11-09
2020-12-01
Brief Summary
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Detailed Description
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Polysomnography, symptom diary and questionnaire (Clinical Global Impression, RBDQ-HK, PSQI, ESS, SSS, ISI, BDI-II) will be performed before and after 4 weeks of each medications.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Melatonin 2mg
4 weeks of 2mg of prolonged release Melatonin
Melatonin 2mg
4 weeks of 2mg prolonged release melatonin (Circadin)
ClonazePAM 0.5 MG
4 weeks of 0.5mg of rivotril
ClonazePAM 0.5 MG
4 weeks of 0.5mg clonazepam (Rivotril)
Interventions
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Melatonin 2mg
4 weeks of 2mg prolonged release melatonin (Circadin)
ClonazePAM 0.5 MG
4 weeks of 0.5mg clonazepam (Rivotril)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* History of psychiatric illness
* Neurodegenerative disease including dementia or parkinsonism.
* Medication affecting sleep within 1 month
* Intake of melatonin or clonazepam within 1 week.
* Unable to complete questionnaires
50 Years
ALL
No
Sponsors
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Kyung Hee University Hospital at Gangdong
OTHER
Responsible Party
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Won Chul Shin
Professor
Principal Investigators
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Won Chul Shin, M.D. Ph.D.
Role: PRINCIPAL_INVESTIGATOR
KyungHee University Hospital at Gangdong
Locations
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Kyung Hee University Hospital at Gangdong
Seoul, , South Korea
Countries
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References
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Ferri R, Marelli S, Ferini-Strambi L, Oldani A, Colli F, Schenck CH, Zucconi M. An observational clinical and video-polysomnographic study of the effects of clonazepam in REM sleep behavior disorder. Sleep Med. 2013 Jan;14(1):24-9. doi: 10.1016/j.sleep.2012.09.009. Epub 2012 Oct 23.
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.
McCarter SJ, Boswell CL, St Louis EK, Dueffert LG, Slocumb N, Boeve BF, Silber MH, Olson EJ, Tippmann-Peikert M. Treatment outcomes in REM sleep behavior disorder. Sleep Med. 2013 Mar;14(3):237-42. doi: 10.1016/j.sleep.2012.09.018. Epub 2013 Jan 23.
McGrane IR, Leung JG, St Louis EK, Boeve BF. Melatonin therapy for REM sleep behavior disorder: a critical review of evidence. Sleep Med. 2015 Jan;16(1):19-26. doi: 10.1016/j.sleep.2014.09.011. Epub 2014 Oct 13.
Nardone R, Golaszewski S, Holler Y, Christova M, Trinka E, Brigo F. Neurophysiological insights into the pathophysiology of REM sleep behavior disorders: a review. Neurosci Res. 2013 Jul;76(3):106-12. doi: 10.1016/j.neures.2013.03.009. Epub 2013 Mar 28.
Iranzo A, Molinuevo JL, Santamaria J, Serradell M, Marti MJ, Valldeoriola F, Tolosa E. Rapid-eye-movement sleep behaviour disorder as an early marker for a neurodegenerative disorder: a descriptive study. Lancet Neurol. 2006 Jul;5(7):572-7. doi: 10.1016/S1474-4422(06)70476-8.
Byun JI, Shin YY, Seong YA, Yoon SM, Hwang KJ, Jung YJ, Cha KS, Jung KY, Shin WC. Comparative efficacy of prolonged-release melatonin versus clonazepam for isolated rapid eye movement sleep behavior disorder. Sleep Breath. 2023 Mar;27(1):309-318. doi: 10.1007/s11325-022-02572-8. Epub 2022 Feb 9.
Other Identifiers
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2017-03-011
Identifier Type: -
Identifier Source: org_study_id
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