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Can ramelteon decrease the tic of Tourette's syndrome

Consideration of the validity of ramelteon for Tourett's syndrome.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs021190012
Enrollment
20
Registered
2019-11-26
Start date
2019-11-26
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Tourett's syndrome Tourett, tic, ramelteon, melatonin

Interventions

Administration of 8 mg of melatonin daily at once before sleep, add to the previous treatment of participants.

Sponsors

SUGAWARA Masashiro
Lead Sponsor
Akita University Hospital
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) 18-30 years of age. 2) Patient who fills the diagnostic criteria of "Tourette's disorder" according to the DSM-5. 3) Patient who can declare the one's written agreement to participate in the study.

Exclusion criteria

Exclusion criteria: 1) Having a history of other neurological and psychiatric disorders that can affect the motor and psychological function. 2) Having a distinct focal lesion on the brain MRI. 3) Patient who had change in the treatment within 4 weeks prior to the registration. 4) Patient who had been medicated ramelteon in the past. 5) Having liver dysfunction. 6) Having severe sleep apnea syndrome. 7) Taking an administration of fluvoxamine maleate.

Design outcomes

Primary

MeasureTime frame
Efficacy; Yale Global Tic Severity Scale (0 week, 2 week, 6 week, 8 week)

Secondary

MeasureTime frame
Y-BOCS, GTS-QOL, pattern of sleep, consentration of dopamin and serotonin in blood plasma, consentration of melatonin in saliva Safety; adversed events, vital signs (blood pressure, puls), laboratory data

Contacts

Public ContactMasashiro SUGAWARA

Akita University Hospital

masashir@gipc.akita-u.ac.jp+81-18-884-6104

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026