sutism spectrm disdorders
Conditions
Interventions
Intervention type:DRUG
Name of intervention:open-label treatment
Dose form / Japanese Medical Device Nomenclature:CAPSULE
Route of administration / Site of application:OROMUCOSAL,NASOGASTRIC
Dose per
Sponsors
main researcher in this study
Prof KHideo Yamanouchi, Saitama Meical University, Departmentof Pedisatrics
Team leader Dr. Masaharu Hayashi,Department of Clinical Neuropathology, Tokyo Metropolitan Institute For Neuroscience
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The Structured Clinical Interview (SCID) for the Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) (First et al., 2002) was employed for diagnoses. For diagnoses of ASD, the semi-structured clinical interview based on the Autism Diagnostic Interview Revised (ADI-R) (Rutter et al., 2003) was also used.
Exclusion criteria
Exclusion criteria: (1) the presence of clinically significant abnormal laboratory data; (2) the presence of neurological disorders or sensory abnormalities; (3)a total IQ of less than 80
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| impaired communication, restricted interests, irritability | — |
Secondary
| Measure | Time frame |
|---|---|
| Significant reduction of scores of the Aberrant Behavior Checklist compared to the baseline. | — |
Countries
Japan
Contacts
Public ContactKunio Yui
Fijimoto Physycal Clinic
Outcome results
None listed