UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000005147
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email hirata@dokkyomed.ac.jp

Sponsor
Institute Post stroke Depression Research Group
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004911

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.