Attention deficit hyperactivity disorder (ADHD)
Conditions
Interventions
Sponsors
University of Fukui, Research Center for Child Mental Development, Division of Psychosocial Support for Nurturing
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Have a clinical diagnosis of ADHD confirmed according to DSM4 criteria. 2) Currently attending Fukui University hospital as an outpatient. 3) Must not be on medication, otherwise no oral intake of medication except for the following; methylphenidate, atomoxetine, atypical antipschotic medication( risperidone, olanzapine, aripiprazole, blonanserin, paliperidone). 4) Subjects within the age range of 6 to 17 years old. 5) No changes in medication for at least 4 weeks prior to baseline visit. 6) Must demonstrate an acceptable degree of compliance with medication and procedures in the opinion of the investigator.
Exclusion criteria
Exclusion criteria: 1) Hypersensitivity towards tipepidine hibenzate. 2) Subjects who have not yet received informed consent of the current diagnosis. 3) Subjects who have any other current DSM4 diagnosis of the following; "Pervasive development disorder", "Schizophrenia and Other Psychotic Disorders","Delirium, Dementia, and Amnestic and Other Cognitive Disorders", "Substance-Related Disorders(exemption of Caffeine related and nicotine related disorders)","mood disorders","eating disorders","personality disorders". 4) Subjects who have a physical disorder with a need of strict diet, or a diagnosis of a severe physical disorder. 5) Subjects who are receiving medication other than the above mentioned. 6) Women who are breastfeeding, pregnant, possibility of pregnancy, or have a wish of early pregnancy. 7) Subjects who have participated in other clinical studies 3 months prior to this study. 8) Subjects who are planned for an immediate therapeutic plan change due to unstable physical or psychological symptoms. 9) Subjects who have a history of suicide attempt within the past 1 year. 10) Subjects who, in the Investigator's opinion, might not be suitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ADHD-RS Clincal global impression DN-CAS | — |
Countries
Japan
Contacts
Public ContactAkemi Tomoda
University of Fukui, Research Center for Child Mental Development Division of Psychosocial Support for Nurturing
Outcome results
None listed