Back to resultsAn Open Study of Tipepidine Hibenzate in Patients With Attention Deficit Hyperactivity Disorder (ADHD)
Primary Purpose
Attention Deficit Disorder With Hyperactivity
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Tipepidine Hibenzate
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity
Eligibility Criteria
[Inclusion Criteria]
- Attention-Deficit/Hyperactivity Disorder (AD/HD) for DSM-IV TR criteria.
- Patients are treated with Atomoxetine, Methylphenidate, atypical antipsychotic drugs (risperidone, olanzapine, quetiapine, perospirone, aripiprazole, blonanserin, paliperidone) or not treated.
- Patients are stable for 4-weeks for medication.
[Exclusion Criteria]
- Patients with a previous hypersensitivity to Tipepidine Hibenzate.
- Patients treated with typical antipsychotics and selective norepinephrine reuptake inhibitor (NRI) except atomoxetine and stimulants except methylphenidate.
- Pregnant or breast-feeding women
Sites / Locations
- Department of Psychiatry, Chiba University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A single-arm study
Arm Description
Outcomes
Primary Outcome Measures
ADHD Rating Scale-IV (ADHD-RS) Japanese Version
The ADHD Rating Scale-IV obtains parent ratings regarding the frequency of each ADHD symptom based on DSM-IV criteria.
The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items).
Secondary Outcome Measures
Cognition using DN-CAS (Das-Naglieri Cognitive Assessment System) Japanese Version
The DN-CAS is an assessment battery designed to evaluate cognitive processing. It was developed to integrate theoretical and applied areas of psychological knowledge using cognitive processing theory and tests designed to measure-Planning, Attention, Simultaneous, and Successive Processing (PASS)-in individuals ages 5-17.
This assessment facilitates mental health professionals in the identification of Attention-Deficit/Hyperactivity Disorder, Traumatic Brain Injury, learning disabilities, Mental Retardation, and giftedness.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01835093
Brief Title
An Open Study of Tipepidine Hibenzate in Patients With Attention Deficit Hyperactivity Disorder (ADHD)
Official Title
Tipepidine for ADHD
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chiba University
4. Oversight
5. Study Description
Brief Summary
Accumulating evidence suggests a role of G protein-coupled inwardly-rectifying potassium (GIRK) channel in the pathology of excitement of nerve, and the medicine with the action (like the Tipepidine Hibenzate) is expected as a new curative medicine of Attention Deficit / Hyperactivity Disorder (AD/HD).
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.
If suggestion is obtained by this research about the effect on AD/HD of Tipepidine Hibenzate, it can contribute to development of the medical treatment of AD/HD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A single-arm study
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tipepidine Hibenzate
Primary Outcome Measure Information:
Title
ADHD Rating Scale-IV (ADHD-RS) Japanese Version
Description
The ADHD Rating Scale-IV obtains parent ratings regarding the frequency of each ADHD symptom based on DSM-IV criteria.
The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items).
Time Frame
Changes from baseline in ADHD-RS at 4-weeks
Secondary Outcome Measure Information:
Title
Cognition using DN-CAS (Das-Naglieri Cognitive Assessment System) Japanese Version
Description
The DN-CAS is an assessment battery designed to evaluate cognitive processing. It was developed to integrate theoretical and applied areas of psychological knowledge using cognitive processing theory and tests designed to measure-Planning, Attention, Simultaneous, and Successive Processing (PASS)-in individuals ages 5-17.
This assessment facilitates mental health professionals in the identification of Attention-Deficit/Hyperactivity Disorder, Traumatic Brain Injury, learning disabilities, Mental Retardation, and giftedness.
Time Frame
Change from baseline in the scores of battery at 4-weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
[Inclusion Criteria]
Attention-Deficit/Hyperactivity Disorder (AD/HD) for DSM-IV TR criteria.
Patients are treated with Atomoxetine, Methylphenidate, atypical antipsychotic drugs (risperidone, olanzapine, quetiapine, perospirone, aripiprazole, blonanserin, paliperidone) or not treated.
Patients are stable for 4-weeks for medication.
[Exclusion Criteria]
Patients with a previous hypersensitivity to Tipepidine Hibenzate.
Patients treated with typical antipsychotics and selective norepinephrine reuptake inhibitor (NRI) except atomoxetine and stimulants except methylphenidate.
Pregnant or breast-feeding women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masaomi Iyo, MD,PhD
Organizational Affiliation
Chairman, Department of Psychiatry, Chiba University Graduate School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Psychiatry, Chiba University School of Medicine
City
Chiba
State/Province
Chuo-ku
ZIP/Postal Code
260-8670
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
24493927
Citation
Sasaki T, Hashimoto K, Tachibana M, Kurata T, Okawada K, Ishikawa M, Kimura H, Komatsu H, Ishikawa M, Hasegawa T, Shiina A, Hashimoto T, Kanahara N, Shiraishi T, Iyo M. Tipepidine in children with attention deficit/hyperactivity disorder: a 4-week, open-label, preliminary study. Neuropsychiatr Dis Treat. 2014 Jan 24;10:147-51. doi: 10.2147/NDT.S58480. eCollection 2014.
Results Reference
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An Open Study of Tipepidine Hibenzate in Patients With Attention Deficit Hyperactivity Disorder (ADHD)
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