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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024197
Receipt No. R000027859
Scientific Title SuPerIoR antIdepressanT Effect of Duloxetine in Japanese patients with post-stroke depression
Date of disclosure of the study information 2016/09/27
Last modified on 2016/09/27

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Basic information
Public title SuPerIoR antIdepressanT Effect of Duloxetine in Japanese patients with post-stroke depression
Acronym SPIRITED Study
Scientific Title SuPerIoR antIdepressanT Effect of Duloxetine in Japanese patients with post-stroke depression
Scientific Title:Acronym SPIRITED Study
Region
Japan

Condition
Condition Post-stroke depression
Classification by specialty
Medicine in general Psychiatry Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of anti-depressant to improve post-stroke depression.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Fugl-Meyer Assessment (FMA) and Functional independence Measure (FIM)
Key secondary outcomes QIDS-J score, Japan Stroke Scale (JSS-DE), Apathy scale, Numerical Rating Scale (NRS), 10m-walk test, Rivermead Mobility Index (RMI)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Duloxetine
Interventions/Control_2 other anti-depressant
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
20 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria (1) Patients who agree to participate in this study and provide their informed consent; (2) aged between 20 and 85 years; (3) since after stroke over 1 month; (4) stroke type is only intracranial hemorrhage or ischemic stroke; (5) inpatients for the rehabilitation therapy; (6) stable general condition.
Key exclusion criteria (1) previous unstable medical condition; (2) severe hepatic or renal dysfunction; (3) severe higher cortical dysfunction; (4) patients whose impairment severlities changed during the study period
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shuji Matsumoto
Organization Kagoshima University
Division name Dept. of Rehabilitation
Zip code
Address 3930-7 Takachiho, Makizono-cho, Kirishima City
TEL 0995-78-2538
Email shushu@m.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shuji Matsumoto
Organization Kagoshima University
Division name Dept. of Rehabilitation
Zip code
Address 3930-7 Takachiho, Makizono-cho, Kirishima City
TEL 0995-78-2538
Homepage URL
Email shushu@m.kufm.kagoshima-u.ac.jp

Sponsor
Institute Kagoshima University
Institute
Department

Funding Source
Organization N/A
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
2016 Year 09 Month 27 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 Preinitiation
Date of protocol fixation
2016 Year 09 Month 27 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 10 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
2016 Year 09 Month 27 Day
Last modified on
2016 Year 09 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027859

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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