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Efficacy and Safety of Melatonin and Clonazepam for IRBD

Sponsor
Kyung Hee University Hospital at Gangdong (Other)
Overall Status
Completed
CT.gov ID
NCT03255642
Collaborator
(none)
34
Enrollment
1
Location
2
Arms
36.7
Actual Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Melatonin 2mg
  • Drug: ClonazePAM 0.5 MG
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective Randomized Open-label studyProspective Randomized Open-label study
Masking:
Single (Outcomes Assessor)
Masking Description:
Mask treatment arm when analyzing polysomnography.
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Melatonin and Rivotril Treatment for Idiopathic Rapid Eye Movement Sleep Disorder: Prospective Randomized Study.
Actual Study Start Date :
Nov 9, 2017
Actual Primary Completion Date :
Dec 1, 2020
Actual Study Completion Date :
Dec 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Melatonin 2mg

4 weeks of 2mg of prolonged release Melatonin

Drug: Melatonin 2mg
4 weeks of 2mg prolonged release melatonin (Circadin)
Other Names:
  • Circadin

    		•
    Placebo Comparator: ClonazePAM 0.5 MG

    4 weeks of 0.5mg of rivotril

    Drug: ClonazePAM 0.5 MG
    4 weeks of 0.5mg clonazepam (Rivotril)
    Other Names:
  • Rivotril

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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

    3. Sleep quality [4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg]

      Pittsburg Sleep Quality Index total score

    4. Depression [4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg]

      Beck depression inventory-II total score

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kyung Hee University Hospital at Gangdong Seoul Korea, Republic of 05269

    Sponsors and Collaborators

    • Kyung Hee University Hospital at Gangdong

    Investigators

    • Principal Investigator: Won Chul Shin, M.D. Ph.D., KyungHee University Hospital at Gangdong

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Won Chul Shin, Professor, Kyung Hee University Hospital at Gangdong
    ClinicalTrials.gov Identifier:
    NCT03255642
    Other Study ID Numbers:
    • 2017-03-011
    First Posted:
    Aug 21, 2017
    Last Update Posted:
    Feb 21, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Won Chul Shin, Professor, Kyung Hee University Hospital at Gangdong
    Clonazepam
    Melatonin
    Treatment
    REM Sleep Behavior Disorder
    Additional relevant MeSH terms:
    REM Sleep Behavior Disorder
    Mental Disorders
    Clonazepam
    Melatonin

    Study Results

    No Results Posted as of Feb 21, 2021