UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of bupropion on cognitive functions in normal subjects using fMRI
Title of the study (Brief title)	Effects of bupropion 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 bupropion 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 bupropion 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 Device,equipment
Interventions/Control_1	1day 1 time bupropion 150mg washout duration 2 weeks 1day 1 time placebo
Interventions/Control_2	1day 1 time placebo washout duration 2 weeks 1day 1 time bupropion 150mg
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	25 years-old <=
Age-upper limit	40 years-old >
Gender	Male and Female
Key inclusion criteria	Healthy adults. Subjects with no history of psychiatric disorders.
Key exclusion criteria	Subject with history of seizure disorders and head injury. Subject with contraindications to MRI. Subjust with drug allergy, taking drugs within 2 weeks of the trial and drinking a lot of alcohol. Woman who is breastfeeding. Pregnant woman and woman suspected of being pregnant.
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 113-8602, Japan
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 113-8602, Japan
TEL	03(3822)2131
Homepage URL
Email	y-ikeda@nms.ac.jp

Sponsor
Institute	Nippon Medical School
Institute
Department

Funding Source
Organization	MEXT
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	2012 Year 02 Month 17 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2011 Year 11 Month 07 Day
Anticipated trial start date	2012 Year 02 Month 01 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	2012 Year 02 Month 17 Day
Last modified on	2017 Year 12 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008621