Clinical trial NCT02836743: Effect of Slow-release Melatonin (Circadin®) Therapy on Idiopathic RBD: a Pilot Study
Official title: Effect of Slow-release Melatonin (Circadin®) Therapy on Idiopathic REM Sleep Behavior Disorder: a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: REM Sleep Behavior Disorder
Keywords: REM sleep behavior disorder
Melatonin
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-07-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Changes in Clinical Global Impression scale
timeFrame: baseline and 4 weeks
measure: Changes in RBDQ-HK score (RBD questionnaire-HK)
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: Sleep quality questionnaire
timeFrame: after taking the treatment for 4 weeks
measure: Sleepiness questionnaire
timeFrame: after taking the treatment for 4 weeks
measure: Quality of life questionnaire
timeFrame: after taking the treatment for 4 weeks
measure: Changes in Dream enactment behavior frequency described in sleep diary
timeFrame: Baseline and 4 weeks
measure: Drug adverse effect
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: Takeuchi N, Uchimura N, Hashizume Y, Mukai M, Etoh Y, Yamamoto K, Kotorii T, Ohshima H, Ohshima M, Maeda H. Melatonin therapy for REM sleep behavior disorder. Psychiatry Clin Neurosci. 2001 Jun;55(3):267-9. doi: 10.1046/j.1440-1819.2001.00854.x.
citation: Kunz D, Bes F. Melatonin as a therapy in REM sleep behavior disorder patients: an open-labeled pilot study on the possible influence of melatonin on REM-sleep regulation. Mov Disord. 1999 May;14(3):507-11. doi: 10.1002/1531-8257(199905)14:33.0.co;2-8.
citation: Boeve BF, Silber MH, Ferman TJ. Melatonin for treatment of REM sleep behavior disorder in neurologic disorders: results in 14 patients. Sleep Med. 2003 Jul;4(4):281-4. doi: 10.1016/s1389-9457(03)00072-8.
citation: Kunz D, Mahlberg R. A two-part, double-blind, placebo-controlled trial of exogenous melatonin in REM sleep behaviour disorder. J Sleep Res. 2010 Dec;19(4):591-6. doi: 10.1111/j.1365-2869.2010.00848.x.