UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005147 |
|---|---|
| Receipt number | R000004911 |
| Scientific Title | Observational study for incidence and therapeutic effect in post stroke depression in Japan |
| Date of disclosure of the study information | 2011/02/26 |
| Last modified on | 2013/09/21 20:34:21 |
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Basic information
Public title
Observational study for incidence and therapeutic effect in post stroke depression in Japan
Acronym
PSD-Japan
Scientific Title
Observational study for incidence and therapeutic effect in post stroke depression in Japan
Scientific Title:Acronym
PSD-Japan
Region
| Japan |
Condition
Condition
post stroke depression
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Incidence of Post-stroke Depression
Basic objectives2
Others
Basic objectives -Others
Epidemiological survery
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
M.I.N.I. International Neuro-Psychiatric Interview 5.0.0
Incidence of PSD in ischemic stroke patients
Key secondary outcomes
1. Time course
2. Therapeutic Effect
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Out patients with ischemic stroke
Key exclusion criteria
inadequate patients designated by investigator
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukito SHINOHARA |
Organization
Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital
Division name
Director
Zip code
Address
4-2-22 Nishiki-cho, Tachikawa, Tokyo, 190-8531, JAPAN
TEL
042-523-3131
yshinoha@tachikawa-hosp.gr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichi HIRATA |
Organization
Dokko Medical University
Division name
Neurology
Zip code
Address
880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi 321-0293 JAPAN
TEL
0282-86-1111
Homepage URL
hirata@dokkyomed.ac.jp
Sponsor or person
Institute
Post stroke Depression Research Group
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2011 | Year | 02 | Month | 26 | 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
| 2007 | Year | 02 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 07 | 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
In ischemic stroke patients (between 1 month and 1 year after onset) whose neurological signs are stable, MINI examinations were performed repeatedly at OPC or ward. The patients whose MINI (1) and/or (2) together with 2 among 9 items were positive were selected as subjects.
The observation of the onset, duration and time course of depression were deserved using the Japan Stroke Scale-depression score, MMSE, SDS and so on in 22 institutes in Japan.
The effects of SSRI were also examined.
Management information
Registered date
| 2011 | Year | 02 | Month | 26 | Day |
Last modified on
| 2013 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004911
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
