Unique ID issued by UMIN | UMIN000024423 |
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Receipt number | R000028095 |
Scientific Title | An Open Study of Tipepidine Hibenzate in Patients With Attention Deficit Hyperactivity Disorder (ADHD) |
Date of disclosure of the study information | 2016/10/15 |
Last modified on | 2016/10/15 20:59:43 |
An Open Study of Tipepidine Hibenzate in Patients With Attention Deficit Hyperactivity Disorder (ADHD)
An Open Study of Tipepidine Hibenzate in Patients With ADHD
An Open Study of Tipepidine Hibenzate in Patients With Attention Deficit Hyperactivity Disorder (ADHD)
An Open Study of Tipepidine Hibenzate in Patients With ADHD
Japan |
Attention Deficit / Hyperactivity Disorder (AD/HD)
Pediatrics | Psychiatry |
Others
NO
The purpose of this research is to confirm the effect by carrying out the additional dosage of the Tipepidine Hibenzate to the AD/HD patients.
Safety,Efficacy
ADHD Rating Scale-IV (ADHD-RS) Japanese Version [ Time Frame: Changes from baseline in ADHD-RS at 4-weeks ]
Cognition using DN-CAS (Das-Naglieri Cognitive Assessment System) Japanese Version [ Time Frame: Change from baseline in the scores of battery at 4-weeks ]
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Tipepidine Hibenzate (30mg/day, 4weeks)
6 | years-old | <= |
17 | years-old | >= |
Male and Female
1.Attention-Deficit/Hyperactivity Disorder (AD/HD) for DSM-IV TR criteria.
2.Patients are treated with Atomoxetine, Methylphenidate, atypical antipsychotic drugs (risperidone, olanzapine, quetiapine, perospirone, aripiprazole, blonanserin, paliperidone) or not treated.
3.Patients are stable for 4-weeks for medication.
1.Patients with a previous hypersensitivity to Tipepidine Hibenzate.
2.Patients treated with typical antipsychotics and selective norepinephrine reuptake inhibitor (NRI) except atomoxetine and stimulants except methylphenidate.
3.Pregnant or breast-feeding women
10
1st name | |
Middle name | |
Last name | Masaomi Iyo |
Chiba University School of Medicine
Department of Psychiatry
1-8-1 Inohana Chiba, Chuo-ku, Japan, 260-8670
043-222-7171
iyom@faculty.chiba-u.jp
1st name | |
Middle name | |
Last name | Tsuyoshi Sasaki |
Chiba University Hospital
Department of Child Psychiatry
1-8-1 Inohana Chiba, Chuo-ku, Japan, 260-8670
043-222-7171
https://clinicaltrials.gov/ct2/show/NCT01835093
sasaki@faculty.chiba-u.jp
Chiba University
Chiba University
Other
YES
https://clinicaltrials.gov/ct2/show/NCT01835093
clinicaltrials.govclinicaltrials.gov
千葉大学医学部附属病院
2016 | Year | 10 | Month | 15 | Day |
https://clinicaltrials.gov/ct2/show/NCT01835093
Published
https://www.ncbi.nlm.nih.gov/pubmed/24493927?dopt=Abstract
Completed
2013 | Year | 04 | Month | 16 | Day |
2013 | Year | 04 | Month | 17 | Day |
2016 | Year | 10 | Month | 15 | Day |
2016 | Year | 10 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028095
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