UMIN-CTR Clinical Trial

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

Attention deficit/hyperactivity disorder (AD/HD)

Classification by specialty

Pediatrics

Psychiatry

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

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

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

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

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

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

Institute

Department of Psychiatry, Chiba University School of Medicine

Institute

Department

Personal name

Organization

Department of Psychiatry, Chiba University School of Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

YES

Study ID_1

NCT02305134

Org. issuing International ID_1

ClinicalTrials.gov

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

千葉大学医学部附属病院

Date of disclosure of the study information

2014

Year

11

Month

25

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2014

Year

11

Month

25

Day

Last modified on

2019

Year

03

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018255