UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024197 |
|---|---|
| Receipt number | 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 22:08:32 |
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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
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
shushu@m.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027859
| 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 |
