Efficacy and Safety of Melatonin and Clonazepam for IRBD

Kyung Hee University

Status: Completed

Conditions: REM Sleep Behavior Disorder

Treatments: Drug: Melatonin 2mg; Drug: ClonazePAM 0.5 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT03255642

2017-03-011

Details and patient eligibility

About

This study aimed to evaluate influence of melatonin or clonazepam treatment on symptom and polysomnographic parameters in patients with idiopathic REM sleep behavior disorder.

Full description

This study is open-label parallel trial with 4 weeks treatment with slow-release melatonin (Circadin) or with clonazepam (Rivotril).

Polysomnography, symptom diary and questionnaire (Clinical Global Impression, RBDQ-HK, PSQI, ESS, SSS, ISI, BDI-II) will be performed before and after 4 weeks of each medications.

Enrollment: 34 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• REM sleep behavior disorder (ICSD-3 criteria)

Exclusion criteria

• Neurological disorder including epilepsy or stroke
• History of psychiatric illness
• Neurodegenerative disease including dementia or parkinsonism.
• Medication affecting sleep within 1 month
• Intake of melatonin or clonazepam within 1 week.
• Unable to complete questionnaires

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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34 participants in 2 patient groups, including a placebo group

Melatonin 2mg

Active Comparator group

Description:

4 weeks of 2mg of prolonged release Melatonin

Treatment:

Drug: Melatonin 2mg

ClonazePAM 0.5 MG

Placebo Comparator group

Description:

4 weeks of 0.5mg of rivotril

Treatment:

Drug: ClonazePAM 0.5 MG