Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate effect of slow-release melatonin (Circadin) on REM sleep behavior disorder.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Circadin 2mg | Experimental | low-dose (2mg) slow-release melatonin for 1 month. |
|
| Circadin 6mg | Experimental | high-dose (6mg) slow-release melatonin for 1 month. |
|
| Placebo | Placebo Comparator | Administer placebo pills with identical morphology |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Circadin | Drug | Slow-release melatonin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Clinical Global Impression scale | baseline and 4 weeks | |
| Changes in RBDQ-HK score (RBD questionnaire-HK) | Baseline and 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep quality questionnaire | PSQI | after taking the treatment for 4 weeks |
| Sleepiness questionnaire | Epworth sleepiness scale | after taking the treatment for 4 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ki-Young Jung, M.D. Ph.D. | Contact | +82-2-2072-4988 | jungky10@gmail.com | |
| Jung-Ick Byun, M.D. | Contact | +82-2-440-6254 | mr830611@gmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11422870 | Background | 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. | |
| 10348479 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 24, 2021 | |
| Reset | Oct 21, 2021 | |
| Release | Apr 20, 2023 | |
| Reset | Jan 12, 2024 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 24, 2021 | Oct 21, 2021 | |||
| Apr 20, 2023 |
| ID | Term |
|---|---|
| D020187 | REM Sleep Behavior Disorder |
| ID | Term |
|---|---|
| D020923 | REM Sleep Parasomnias |
| D020447 | Parasomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug |
|
| Quality of life questionnaire | SF-36 version 2. | after taking the treatment for 4 weeks |
| Changes in Dream enactment behavior frequency described in sleep diary | Baseline and 4 weeks |
| Drug adverse effect | adverse events and reason for drug withdrawal | 4 weeks |
| 14592300 | Background | 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. |
| 20561180 | Background | 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. |
| Jan 12, 2024 |
| D001523 |
| Mental Disorders |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |