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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002977
Receipt No. R000003612
Scientific Title Administration of Paroxetine Attenuates cognitive functon by using fMRI.
Date of disclosure of the study information 2010/01/05
Last modified on 2010/01/05

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Basic information
Public title Administration of Paroxetine Attenuates cognitive functon by using fMRI.
Acronym Administration of Paroxetine Attenuates cognitive functon by using fMRI.
Scientific Title Administration of Paroxetine Attenuates cognitive functon by using fMRI.
Scientific Title:Acronym Administration of Paroxetine Attenuates cognitive functon by using fMRI.
Region
Japan

Condition
Condition depression
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate the effect of SSRI for human cognitive function.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase IV

Assessment
Primary outcomes Comparison between placebo, non drug, SSRI conditions.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 1day
Paroxetine 20mg
1 time
washout duration 2weeks
Interventions/Control_2 1day
placebo
1 time
washout duration 2weeks
Interventions/Control_3 1day
non drug
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
35 years-old >
Gender Male and Female
Key inclusion criteria healthy adult
Key exclusion criteria patients with psychiatric disorder
patients with hepatic, kidney, cardiac disorders
patients taking other drugs
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuya Matsuda
Organization Tamagawa University
Division name Brain Science Institute
Zip code
Address 6-1-1, Tamagawagekuen, Machida, Tokyo 194-8610, Japan
TEL 042-739-8458
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Tamagawa University
Division name Research Institute
Zip code
Address
TEL 042-739-8666
Homepage URL
Email

Sponsor
Institute Tamagawa University
Institute
Department

Funding Source
Organization MEXT
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Nihon Medical School
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
2010 Year 01 Month 05 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 No longer recruiting
Date of protocol fixation
2009 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 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
2010 Year 01 Month 05 Day
Last modified on
2010 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003612

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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