NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs021190012

Registered date:26/11/2019

Can ramelteon decrease the tic of Tourette's syndrome

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedTourett's syndrome
Date of first enrollment26/11/2019
Target sample size20
Countries of recruitment
Study typeInterventional
Intervention(s)Administration of 8 mg of melatonin daily at once before sleep, add to the previous treatment of participants.

Outcome(s)

Primary OutcomeEfficacy; Yale Global Tic Severity Scale (0 week, 2 week, 6 week, 8 week)
Secondary OutcomeY-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
GenderBoth
Include criteria1) 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 criteria1) 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

Contact

Public contact
Name Masashiro SUGAWARA
Address 1-1-1 Hondo Akita, Japan Akita Japan 010-8543
Telephone +81-18-884-6104
E-mail masashir@gipc.akita-u.ac.jp
Affiliation Akita University Hospital
Scientific contact
Name Masashiro SUGAWARA
Address 1-1-1 Hondo Akita, Japan Akita Japan 010-8543
Telephone +81-18-884-6104
E-mail masashir@gipc.akita-u.ac.jp
Affiliation Akuta University Hospital