Clinical trial NCT03255642: Efficacy and Safety of Melatonin and Clonazepam for IRBD
Official title: Efficacy and Safety of Melatonin and Rivotril Treatment for Idiopathic Rapid Eye Movement Sleep Disorder: Prospective Randomized Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: REM Sleep Behavior Disorder
Keywords: Clonazepam
Melatonin
Treatment
REM Sleep Behavior Disorder
Lead sponsor: Kyung Hee University Hospital at Gangdong
Sponsor class: OTHER
First posted: 2017-08-21
Enrollment: 34
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective Randomized Open-label study
Primary purpose: TREATMENT

Brief summary: This study aimed to evaluate influence of melatonin or clonazepam treatment on symptom and polysomnographic parameters in patients with idiopathic REM sleep behavior disorder.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* REM sleep behavior disorder (ICSD-3 criteria)

Exclusion Criteria:

* Neurological disorder including epilepsy or stroke
* 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

Primary outcomes:
measure: Automated REM without atonia index
timeFrame: 4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg
Secondary outcomes:
measure: Clinical Global Impression of RBD symptom severity
timeFrame: 4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg
measure: REM sleep behavior disorder symptom severity
timeFrame: 4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg
measure: Sleep quality
timeFrame: 4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg
measure: Depression
timeFrame: 4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong
Study officials:
affiliation: KyungHee University Hospital at Gangdong
name: Won Chul Shin, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.