Effect of Slow-release Melatonin (Circadin®) Therapy on Idiopathic RBD: a Pilot Study

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ClinicalTrials.gov Identifier: NCT02836743

Recruitment Status : Unknown

Verified April 2017 by Ki-Young Jung, Seoul National University Hospital.
Recruitment status was: Recruiting

First Posted : July 19, 2016

Last Update Posted : April 28, 2017

Sponsor:

Information provided by (Responsible Party):

Ki-Young Jung, Seoul National University Hospital

Study Description

Brief Summary:

To evaluate effect of slow-release melatonin (Circadin) on REM sleep behavior disorder.

Condition or disease	Intervention/treatment	Phase
REM Sleep Behavior Disorder	Drug: Circadin Drug: Placebo	Phase 4

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	30 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
Official Title:	Effect of Slow-release Melatonin (Circadin®) Therapy on Idiopathic REM Sleep Behavior Disorder: a Pilot Study
Study Start Date :	January 2016
Estimated Primary Completion Date :	December 31, 2017
Estimated Study Completion Date :	December 31, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Circadin 2mg low-dose (2mg) slow-release melatonin for 1 month.	Drug: Circadin Slow-release melatonin Other Name: slow-release melatonin
Experimental: Circadin 6mg high-dose (6mg) slow-release melatonin for 1 month.	Drug: Circadin Slow-release melatonin Other Name: slow-release melatonin
Placebo Comparator: Placebo Administer placebo pills with identical morphology	Drug: Placebo

Outcome Measures

Primary Outcome Measures :

Changes in Clinical Global Impression scale [ Time Frame: baseline and 4 weeks ]
Changes in RBDQ-HK score (RBD questionnaire-HK) [ Time Frame: Baseline and 4 weeks ]

Secondary Outcome Measures :

Sleep quality questionnaire [ Time Frame: after taking the treatment for 4 weeks ]
PSQI
Sleepiness questionnaire [ Time Frame: after taking the treatment for 4 weeks ]
Epworth sleepiness scale
Quality of life questionnaire [ Time Frame: after taking the treatment for 4 weeks ]
SF-36 version 2.
Changes in Dream enactment behavior frequency described in sleep diary [ Time Frame: Baseline and 4 weeks ]
Drug adverse effect [ Time Frame: 4 weeks ]
adverse events and reason for drug withdrawal

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.)

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836743

Contacts

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Contact: Ki-Young Jung, M.D. Ph.D.	+82-2-2072-4988	jungky10@gmail.com
Contact: Jung-Ick Byun, M.D.	+82-2-440-6254	mr830611@gmail.com

Locations

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Korea, Republic of
Seoul National University Hospital	Recruiting
Seoul, Korea, Republic of
Contact: Ki-Young Jung, professor +82-2-2072-0694 jungky10@gmail.com

Sponsors and Collaborators

Seoul National University Hospital

More Information

Publications:

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.

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.

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.

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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Responsible Party:	Ki-Young Jung, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT02836743
Other Study ID Numbers:	1505-084-673
First Posted:	July 19, 2016 Key Record Dates
Last Update Posted:	April 28, 2017
Last Verified:	April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

Keywords provided by Ki-Young Jung, Seoul National University Hospital:


REM sleep behavior disorder Melatonin

Additional relevant MeSH terms:

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REM Sleep Behavior Disorder Mental Disorders REM Sleep Parasomnias Parasomnias Sleep Wake Disorders Nervous System Diseases	Melatonin Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Central Nervous System Depressants

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