Efficacy of melatonin in idiopathic rapid eye movement (REM) sleep behaviour disorder

Efficacy of melatonin in idiopathic rapid eye movement (REM) sleep behaviour disorder: A double-blind, randomised controlled trial

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000647730

Acronym

M-iRBD

Enrollment

Registered

2013-06-11

Start date

2014-10-20

Completion date

2016-01-18

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary aim of the study is to test in a randomised, double blind, placebo controlled trial the efficacy of melatonin in patients with REM sleep behaviour disorder over 8 weeks of treatment Specifically, we will test the hypothesis that, compared to placebo, melatonin treatment will result in a reduction in the frequency of patients' self reported events.

Interventions

Circadin prolonged release tablet 2 mg (prolonged release melatonin 2mg) - 1x2tablets (total of 4mg per day), orally ingested , after food, within 1 hour bedtime for 8 weeks Total duration of the trial is 16 weeks: 4 weeks of screening period, 8 weeks of treatment period, 4 weeks of followup period.

Study design

Allocation

Randomised controlled trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1) Age over 18 2) MiniMental State Examination>/=24 3) REM sleep Behaviour Disorde (RBD)r as defined by the International Classification for Sleep Disorder criteria (ICSD-2) 4) Screening questionnaire criteria (RBDSQ) with a score equal or greater than 5/13 confirmed by bed partner 5) Two or more events of RBD defined by dream enactment behaviour and/or sleep related injuries (question 2 and 4 of the wCIRUS-RBDQ) during the 4 weeks (screening period) prior to randomisation. 6) Stable medications for 1 month prior to randomisation.

Exclusion criteria

1) Untreated Obstructive sleep apnea with Apnea Hypopnea Index >20 2) Significant psychiatric disorder or cognitive impairment (MMSE< 24) 3) Any significant liver, kidney or autoimmune disease. 4) Current use of benzodiazepines or other non-benzodiazepine hypnotics (e.g. zaleplon, zolpidem, zopiclone), native compounds of melatonin, other melatoninergic agonists,, unless washout of more than four weeks 5) Drug-induced RBD (antidepressants) with clear relation between RBD onset and medication 6) Excessive alcohol consumption (>25 Unit/week) 7) Pregnancy or lactation 8) Use of light therapy (for treatment of sleep-wake disorders) within the last 6 months 9) Galactose intolerance, LAPP lactase deficiency or glucose-galactose malabsorption

Outcome results