UMIN-CTR Clinical Trial

Basic information
Public title	Tipepidine in children with attention deficit/hyperactivity disorder (AD/HD): a Double-blind, Placebo-controlled Trial
Acronym	Tipepidine in children with attention deficit/hyperactivity disorder (AD/HD): a Double-blind, Placebo-controlled Trial
Scientific Title	Tipepidine in children with attention deficit/hyperactivity disorder (AD/HD): a Double-blind, Placebo-controlled Trial
Scientific Title:Acronym	Tipepidine in children with attention deficit/hyperactivity disorder (AD/HD): a Double-blind, Placebo-controlled Trial
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	Primary Purpose: Treatment in children with attention deficit/hyperactivity disorder (AD/HD) (Age:6-17) Study Phase: Phase 1/Phase 2 Intervention Model: Parallel Assignment Number of Arms: 2 Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Allocation: Randomized Endpoint Classification: Safety/Efficacy Study
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	Primary Outcome Measure: The ADHD Rating Scale IV Japanese Version (ADHD-RS-IV-J) by physician. Time Frame: Changes from baseline in ADHD-RS-IV-J at 4-weeks
Key secondary outcomes	Time Frame: Changes from baseline in at 4-weeks of 1-5. 1. Subscores (Inattentive subscore, Hyperactive/impulsive subscore) of the ADHD-RS-IV-J by physician. 2. Total scores and subscores (Inattentive subscore, Hyperactive/impulsive subscore) of the ADHD-RS-IV-J by parents. 3. Total scores and subscores (planning subscore, attention subscore, simultaneous subscore, successive subscore) of DN-CAS (Das-Naglieri Cognitive Assessment System) Japanese Version. 4. Scores of CGI-ADHD-S, CGI-ADHD-I 5. Biologocal markers (Serum levels of Pro-BDNF, Mature-BDNF, Oxytocin)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Tipepidine Hibenzate
Interventions/Control_2	Placebo
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) Diagnosis of attention deficit hyperactivity disorder besed on DSM-5 criteria. (2) Scores of 20 or higher in ADHD-RS (physician evaluation) total score. (3) currently is an outpatient at Chiba University Hospital Department of Psychiatry or Child Psychiatry. (4) currently receiving no medications for ADHD (atomoxetine, methylphenidate) treatment for the previous 4 weeks prior to enrollment in this study. (5) currently receiving no medications of antidepressants, mood stabilizers and the antipsychotics treatment for the previous 4 weeks prior to enrollment in this study. (6) currently receiving no medications of GIRK channel antagonist (tipepidine, cloperastine, caramiphen) treatment for the previous 4 weeks prior to enrollment in this study. (7) Ages 6 - 17, male or female (8) Provision of written informed consent by patients and parents or guardian. (9) must be able to swallow capsuled medicine.
Key exclusion criteria	(1) History of allergic reaction or hypersensitivity to tipepidine hibenzate. (2) Patients who have not been informed of having the disease at the time of informed consent. (3) Diagnosis of any of the following diseases based on the DSM-5 criteria. Autism Spectrum Disorder, Schizophrenia Spectrum and Other Psychotic Disorders, Neurocognitive Disorders, Substance Related and Addictive Disorders, Feeding and Eating Disorders, Personality Disorders, Paraphilic Disorders. (4) currently receiving medications for ADHD (atomoxetine, methylphenidate) treatment for the previous 4 weeks prior to enrollment in this study. (5) currently receiving medications of antidepressants, mood stabilizers and the antipsychotics treatment for the previous 4 weeks prior to enrollment in this study. (6) currently receiving medications of GIRK channel antagonist (tipepidine, cloperastine, caramiphen) treatment for the previous 4 weeks prior to enrollment in this study. (7) Somatic disorder which requires severe body management or severe meal management. (8) participating in another clinical trial within 3 months prior to enrollment into this study. (except for observation study without intervention). (9) planning change of treatment because of unstable neurological manifestations or somatic symptoms. (10) History of suicidal ideation within the past year. (11) pregnant or nursing, or intending to become pregnant or to start breastfeeding during the study. (12) Other clinically significant reasons for exclusion by investigators.
Target sample size	80

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

Public contact
1st name of contact person	1st name Tsuyoshi Middle name Last name Sasaki
Organization	Chiba University Hospital
Division name	Department of Child Psychiatry
Zip code	260-8670
Address	1-8-1 Inohana, Chuo-ku, Chiba, Japan 260-8670
TEL	043-222-7171
Homepage URL
Email	sasaki@faculty.chiba-u.jp

Sponsor
Institute	Department of Psychiatry, Chiba University School of Medicine
Institute
Department

Funding Source
Organization	Department of Psychiatry, Chiba University School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Chiba-University Hospital
Address	1-8-1 Inohana, Chuo-ku, Chiba, JAPAN
Tel	043-222-7171
Email	shiken@office.chiba-u.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	NCT02305134
Org. issuing International ID_1	ClinicalTrials.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	2014 Year 11 Month 25 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 21 Day
Date of IRB	2014 Year 10 Month 21 Day
Anticipated trial start date	2015 Year 01 Month 06 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 11 Month 25 Day
Last modified on	2019 Year 03 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018255