UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An Open Study of Tipepidine Hibenzate in Patients With Attention Deficit Hyperactivity Disorder (ADHD)
Title of the study (Brief title)	An Open Study of Tipepidine Hibenzate in Patients With ADHD
Region	Japan

Condition
Condition	Attention Deficit / Hyperactivity Disorder (AD/HD)
Classification by specialty	Pediatrics Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	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.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	ADHD Rating Scale-IV (ADHD-RS) Japanese Version [ Time Frame: Changes from baseline in ADHD-RS at 4-weeks ]
Key secondary outcomes	Cognition using DN-CAS (Das-Naglieri Cognitive Assessment System) Japanese Version [ Time Frame: Change from baseline in the scores of battery at 4-weeks ]

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Tipepidine Hibenzate (30mg/day, 4weeks)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	6 years-old <=
Age-upper limit	17 years-old >=
Gender	Male and Female
Key inclusion criteria	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.
Key exclusion criteria	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
Target sample size	10

Research contact person
Name of lead principal investigator	Masaomi Iyo
Organization	Chiba University School of Medicine
Division name	Department of Psychiatry
Address	1-8-1 Inohana Chiba, Chuo-ku, Japan, 260-8670
TEL	043-222-7171
Email	iyom@faculty.chiba-u.jp

Public contact
Name of contact person	Tsuyoshi Sasaki
Organization	Chiba University Hospital
Division name	Department of Child Psychiatry
Address	1-8-1 Inohana Chiba, Chuo-ku, Japan, 260-8670
TEL	043-222-7171
Homepage URL	https://clinicaltrials.gov/ct2/show/NCT01835093
Email	sasaki@faculty.chiba-u.jp

Sponsor
Institute	Chiba University
Institute
Department

Funding Source
Organization	Chiba University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	YES
Study ID_1	https://clinicaltrials.gov/ct2/show/NCT01835093
Org. issuing International ID_1	clinicaltrials.govclinicaltrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	千葉大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 04 Month 16 Day
Anticipated trial start date	2013 Year 04 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol	https://clinicaltrials.gov/ct2/show/NCT01835093
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/24493927?dopt=Abstract
Results
Other related information

Management information
Registered date	2016 Year 10 Month 15 Day
Last modified on	2016 Year 10 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028095