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This study aimed to evaluate influence of melatonin or clonazepam treatment on symptom and polysomnographic parameters in patients with idiopathic REM sleep behavior disorder.
This study is open-label parallel trial with 4 weeks treatment with slow-release melatonin (Circadin) or with clonazepam (Rivotril).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melatonin 2mg | Active Comparator | 4 weeks of 2mg of prolonged release Melatonin |
|
| ClonazePAM 0.5 MG | Placebo Comparator | 4 weeks of 0.5mg of rivotril |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin 2mg | Drug | 4 weeks of 2mg prolonged release melatonin (Circadin) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Automated REM without atonia index | Percentage seconds with chin EMG amplitude<1uV/ Total REM seconds. | 4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression of RBD symptom severity | Clinical Global Impression scale score provided by patient and caregiver. | 4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg |
| REM sleep behavior disorder symptom severity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Won Chul Shin, M.D. Ph.D. | KyungHee University Hospital at Gangdong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyung Hee University Hospital at Gangdong | Seoul | 05269 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23098778 | Background | 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. | |
| 20561180 | Background | 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. |
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| ID | Term |
|---|---|
| D020187 | REM Sleep Behavior Disorder |
| ID | Term |
|---|---|
| D020923 | REM Sleep Parasomnias |
| D020447 | Parasomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| D002998 | Clonazepam |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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Prospective Randomized Open-label study
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Mask treatment arm when analyzing polysomnography.
| ClonazePAM 0.5 MG | Drug | 4 weeks of 0.5mg clonazepam (Rivotril) |
|
|
REM sleep behavior disorder questionnaire-Hong Kong total score
| 4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg |
| Sleep quality | Pittsburg Sleep Quality Index total score | 4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg |
| Depression | Beck depression inventory-II total score | 4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg |
| 23352028 | Background | 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. |
| 25454845 | Background | 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. |
| 23542221 | Background | 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. |
| 16781987 | Background | 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. |
| 35141811 | Derived | 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. |
| D001523 |
| Mental Disorders |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |