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

REM Sleep Behavior Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02836743
• Other study ID #: 1505-084-673
• Status: Recruiting
• Phase: Phase 4
• First received: July 13, 2016
• Last updated: April 26, 2017
• Start date: January 2016
• Est. completion date: December 31, 2017

Study information

• Verified date: April 2017
• Source: Seoul National University Hospital
• Contact: Ki-Young Jung, M.D. Ph.D.
• Phone: +82-2-2072-4988
• Email: jungky10[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Mental Disorders
• REM Sleep Behavior Disorder

Intervention

Drug:
• Circadin
Slow-release melatonin
• Placebo

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

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. — View Citation

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. — View 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Clinical Global Impression scale		baseline and 4 weeks
Primary	Changes in RBDQ-HK score (RBD questionnaire-HK)		Baseline and 4 weeks
Secondary	Sleep quality questionnaire	PSQI	after taking the treatment for 4 weeks
Secondary	Sleepiness questionnaire	Epworth sleepiness scale	after taking the treatment for 4 weeks
Secondary	Quality of life questionnaire	SF-36 version 2.	after taking the treatment for 4 weeks
Secondary	Changes in Dream enactment behavior frequency described in sleep diary		Baseline and 4 weeks
Secondary	Drug adverse effect	adverse events and reason for drug withdrawal	4 weeks