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

Phase 4

• Conditions: REM Sleep Behavior Disorder
• Interventions: Drug: Circadin; Drug: Placebo

• Registration Number: NCT02836743
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

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 Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-07-13
• Study First Submitted QC: 2016-07-18
• Study First Posted: 2016-07-19
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-26
• Last Update Posted: 2017-04-28
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Circadin 2mg	Circadin	low-dose (2mg) slow-release melatonin for 1 month.
Circadin 6mg	Circadin	high-dose (6mg) slow-release melatonin for 1 month.
Placebo	Placebo	Administer placebo pills with identical morphology

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of