Effect of Slow-release Melatonin (Circadin®) Therapy on Idiopathic RBD: a Pilot Study
Study Details
Study Description
Brief Summary
To evaluate effect of slow-release melatonin (Circadin) on REM sleep behavior disorder.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Circadin 2mg low-dose (2mg) slow-release melatonin for 1 month. |
Drug: Circadin
Slow-release melatonin
Other Names:
|
| Experimental: Circadin 6mg high-dose (6mg) slow-release melatonin for 1 month. |
Drug: Circadin
Slow-release melatonin
Other Names:
|
| Placebo Comparator: Placebo Administer placebo pills with identical morphology |
Drug: Placebo
|
Outcome Measures
Primary Outcome Measures
- Changes in Clinical Global Impression scale [baseline and 4 weeks]
- Changes in RBDQ-HK score (RBD questionnaire-HK) [Baseline and 4 weeks]
Secondary Outcome Measures
- Sleep quality questionnaire [after taking the treatment for 4 weeks]
PSQI
- Sleepiness questionnaire [after taking the treatment for 4 weeks]
Epworth sleepiness scale
- Quality of life questionnaire [after taking the treatment for 4 weeks]
SF-36 version 2.
- Changes in Dream enactment behavior frequency described in sleep diary [Baseline and 4 weeks]
- Drug adverse effect [4 weeks]
adverse events and reason for drug withdrawal
Eligibility Criteria
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.)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seoul National University Hospital | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Seoul National University Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 1505-084-673