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OpenTrials
Completed

NCT Number: NCT03255642

Efficacy and Safety of Melatonin and Clonazepam for IRBD

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

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Key information

Conditions

REM Sleep Behavior Disorder Mental Disorders Nervous System Diseases Parasomnias REM Sleep Parasomnias Sleep Wake Disorders

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kyung Hee University Hospital at Gangdong

Seoul, 05269, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Melatonin 2mg

Drug

4 weeks of 2mg prolonged release melatonin (Circadin)

Other names: Circadin

ClonazePAM 0.5 MG

Drug

4 weeks of 0.5mg clonazepam (Rivotril)

Other names: Rivotril

Primary outcomes

  1. Automated REM without atonia index

    Time frame: 4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg

    Percentage seconds with chin EMG amplitude<1uV/ Total REM seconds.

Secondary outcomes

  1. Clinical Global Impression of RBD symptom severity

    Time frame: 4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg

    Clinical Global Impression scale score provided by patient and caregiver.

  2. REM sleep behavior disorder symptom severity

    Time frame: 4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg

    REM sleep behavior disorder questionnaire-Hong Kong total score

  3. Sleep quality

    Time frame: 4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg

    Pittsburg Sleep Quality Index total score

  4. Depression

    Time frame: 4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg

    Beck depression inventory-II total score

Sponsors and collaborators

Lead sponsor

Kyung Hee University Hospital at Gangdong

Other

Registry information

Official study title

Efficacy and Safety of Melatonin and Rivotril Treatment for Idiopathic Rapid Eye Movement Sleep Disorder: Prospective Randomized Study.

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 21, 2017
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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