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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02836743

Enrollment

Registered

2016-07-19

Start date

2016-01-31

Completion date

2017-12-31

Last updated

2017-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

REM Sleep Behavior Disorder

Keywords

REM sleep behavior disorder, Melatonin

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.

Interventions

DRUGCircadin

Slow-release melatonin

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.)

Design outcomes

Primary

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

Measure	Time frame	Description
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
Drug adverse effect	4 weeks	adverse events and reason for drug withdrawal
Changes in Dream enactment behavior frequency described in sleep diary	Baseline and 4 weeks	—
Sleepiness questionnaire	after taking the treatment for 4 weeks	Epworth sleepiness scale

Countries

South Korea

Contacts

Primary ContactKi-Young Jung, M.D. Ph.D.

jungky10@gmail.com+82-2-2072-4988

Backup ContactJung-Ick Byun, M.D.

mr830611@gmail.com+82-2-440-6254

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026