Can ramelteon decrease the tic of Tourette's syndrome

JRCT ID: jRCTs021190012

Registered date:26/11/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Tourett's syndrome
• Date of first enrollment: 26/11/2019
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Administration of 8 mg of melatonin daily at once before sleep, add to the previous treatment of participants.

Outcome(s)

• Primary Outcome: Efficacy; Yale Global Tic Severity Scale (0 week, 2 week, 6 week, 8 week)

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 30age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: SUGAWARA Masashiro
• Secondary Sponsor: Akita University Hospital