Efficacy and Safety of Melatonin and Clonazepam for IRBD

Not Applicable

Completed

• Conditions: REM Sleep Behavior Disorder
• Interventions: Drug: Melatonin 2mg; Drug: ClonazePAM 0.5 MG

• Registration Number: NCT03255642
• Lead Sponsor: Kyung Hee University Hospital at Gangdong

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2017-05-29
• Study First Submitted QC: 2017-08-16
• Study First Posted: 2017-08-21
• Study Start: 2017-11-09
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-18
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Melatonin 2mg	Melatonin 2mg	4 weeks of 2mg of prolonged release Melatonin
ClonazePAM 0.5 MG	ClonazePAM 0.5 MG	4 weeks of 0.5mg of rivotril

Primary Outcome Measures

Name	Time	Method
Automated REM without atonia index	4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg	Percentage seconds with chin EMG amplitude\<1uV/ Total REM seconds.

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression of RBD symptom severity	4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg	Clinical Global Impression scale score provided by patient and caregiver.
Depression	4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg	Beck depression inventory-II total score
REM sleep behavior disorder symptom severity	4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg	REM sleep behavior disorder questionnaire-Hong Kong total score
Sleep quality	4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg	Pittsburg Sleep Quality Index total score

Trial Locations

Locations (1)

Kyung Hee University Hospital at Gangdong; 🇰🇷 Seoul, Korea, Republic of