UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002977 |
|---|---|
| Receipt number | 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 17:28:46 |
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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
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
Sponsor or person
Institute
Tamagawa University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003612
