Tourette'
Conditions
Interventions
8 mg of ramelteon is added to preceding treatment before a sleep once a day. Administration period is 6 weeks.
Sponsors
Akita University Graduate School of Medicine
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-V. 3) Patient who can declare the one's own 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
| Measure | Time frame |
|---|---|
| Efficacy; Yale Global Tic Severity Scale (0W, 2W, 6W, 8W) | — |
Secondary
| Measure | Time frame |
|---|---|
| Y-BOCS, GTS-QOL, pattern of sleep Safety; Adverse events and adverse effects (vital sign, laboratory data) | — |
Countries
Japan
Contacts
Public ContactMasashiro SUGAWARA
Akita University Hospital Dept. of Neurology
Outcome results
None listed