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

Seoul National University

Status and phase: Unknown; Phase 4

Conditions: REM Sleep Behavior Disorder

Treatments: Drug: Placebo; Drug: Circadin

Study type: Interventional

Funder types: Other

Identifiers

NCT02836743

1505-084-673

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 3 patient groups, including a placebo group

Circadin 2mg

Experimental group

Description:

low-dose (2mg) slow-release melatonin for 1 month.

Treatment:

Drug: Circadin

Circadin 6mg

Experimental group

Description:

high-dose (6mg) slow-release melatonin for 1 month.

Treatment:

Drug: Circadin

Placebo

Placebo Comparator group

Description:

Administer placebo pills with identical morphology

Treatment:

Drug: Placebo