UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012947
Receipt number R000015143
Scientific Title Effects of atomoxetine on cognitive functions in normal subjects using fMRI
Date of disclosure of the study information 2014/01/24
Last modified on 2016/10/04 17:01:39

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Basic information

Public title

Effects of atomoxetine on cognitive functions in normal subjects using fMRI

Acronym

Effects of atomoxetine on cognitive functions in normal subjects using fMRI

Scientific Title

Effects of atomoxetine on cognitive functions in normal subjects using fMRI

Scientific Title:Acronym

Effects of atomoxetine on cognitive functions in normal subjects using fMRI

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to investigate the effects of atomoxetine on human cognitive functions.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Comparison of BOLD signal changes measured by fMRI between placebo and atomoxetine conditions.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

1day 1 time atomoxetine 40 mg
Washout duration 1 week
1day 1 time placebo

Interventions/Control_2

1day 1 time placebo
Washout duration 1 week
1day 1 time atomoxetine 40 mg

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

20 years-old <=

Age-upper limit

40 years-old >

Gender

Male and Female

Key inclusion criteria

Subjects with no history of psychiatric disorders.
Subjects who have the ability to provide informed consent and adhere to the protocol.

Key exclusion criteria

Subjects with drug allergy.
Subjects with cardiovascular disorder, glaucoma, liver and renal dysfunction, urination difficulty.
Subjects with history of pheochromocytoma, convulsive seizure, hypertension, cerebrovascular disorder, orthostatic hypotension.
Subjects taking any drug within 1 week.
Subjects with contraindications to MRI.
Subjects who are judged as not suitable for participation in this study.

Target sample size

25


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hidenori Suzuki

Organization

Nippon Medical School

Division name

Department of Pharmacology

Zip code


Address

1-1-5, Sendagi, Bunkyo-ku, Tokyo

TEL

03-3822-2131

Email

hsuzuki@nms.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yumiko Ikeda

Organization

Nippon Medical School

Division name

Department of Pharmacology

Zip code


Address

1-1-5, Sendagi, Bunkyo-ku, Tokyo

TEL

03-3822-2131

Homepage URL


Email

y-ikeda@nms.ac.jp


Sponsor or person

Institute

Nippon Medical School

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2014 Year 01 Month 24 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

Suspended

Date of protocol fixation

2012 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 12 Month 26 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 01 Month 24 Day

Last modified on

2016 Year 10 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015143


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name