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

Effect of Slow-release Melatonin (Circadin®) Therapy on Idiopathic REM Sleep Behavior Disorder: a Pilot Study

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

Study Overview

• Status: Unknown
• Conditions: REM Sleep Behavior Disorder
• Intervention / Treatment: Drug: Placebo; Drug: Circadin

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ki-Young Jung, M.D. Ph.D.; Phone Number: +82-2-2072-4988; Email: jungky10@gmail.com
• Study Contact Backup: Name: Jung-Ick Byun, M.D.; Phone Number: +82-2-440-6254; Email: mr830611@gmail.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): December 31, 2017
• Study Completion (Anticipated): December 31, 2017

Study Registration Dates

• First Submitted: July 13, 2016
• First Submitted That Met QC Criteria: July 18, 2016
• First Posted (Estimate): July 19, 2016

Study Record Updates

• Last Update Posted (Actual): April 28, 2017
• Last Update Submitted That Met QC Criteria: April 26, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Melatonin; REM sleep behavior disorder
• Additional Relevant MeSH Terms: Nervous System Diseases; Sleep Wake Disorders; Parasomnias; REM Sleep Parasomnias; Mental Disorders; REM Sleep Behavior Disorder; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Antioxidants; Melatonin
• Other Study ID Numbers: 1505-084-673

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided