UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of atomoxetine on cognitive functions in normal subjects using fMRI
Title of the study (Brief title)	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	Hidenori Suzuki
Organization	Nippon Medical School
Division name	Department of Pharmacology
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL	03-3822-2131
Email	hsuzuki@nms.ac.jp

Public contact
Name of contact person	Yumiko Ikeda
Organization	Nippon Medical School
Division name	Department of Pharmacology
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL	03-3822-2131
Homepage URL
Email	y-ikeda@nms.ac.jp

Sponsor
Institute	Nippon Medical School
Institute
Department

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)

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

Progress
Recruitment status	Suspended
Date of protocol fixation	2012 Year 12 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015143