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

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

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

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