UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008312 |
|---|---|
| Receipt number | R000009789 |
| Scientific Title | The clinical intervention trial to post stroke depression and apathy |
| Date of disclosure of the study information | 2012/07/08 |
| Last modified on | 2012/07/24 16:03:06 |
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Basic information
Public title
The clinical intervention trial to post stroke depression and apathy
Acronym
The clinical intervention trial to post stroke depression and apathy
Scientific Title
The clinical intervention trial to post stroke depression and apathy
Scientific Title:Acronym
The clinical intervention trial to post stroke depression and apathy
Region
| Japan |
Condition
Condition
Post stroke depression and apathy
Classification by specialty
| Neurology | Psychiatry | Neurosurgery |
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of the most suitable medical therapy for post stroke depression and apathy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
FIM gain
FIM efficacy
Key secondary outcomes
Zung Self-Rating Depression Scale gain
Apathy Score gain
SADQ-H10 gain
Vitality index gain
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
9
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The group which accepts only PSD
The paroxetine group
Interventions/Control_2
The group which accepts only PSD
The milnaciplan group
Interventions/Control_3
The group which accepts only PSD
The nicergolin group
Interventions/Control_4
The group which accepts both of PSD and apathy
The milnaciplan group
Interventions/Control_5
The group which accepts both of PSD and apathy
The amantadine group
Interventions/Control_6
The group which accepts both of PSD and apathy
The nicergoline group
Interventions/Control_7
The group which accepts only apathy
The amantadine group
Interventions/Control_8
The group which accepts only apathy
The bromocriptine group
Interventions/Control_9
The group which accepts only apathy
The nicergoline group
Interventions/Control_10
Eligibility
Age-lower limit
| 25 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Stroke
2.More than GCS13 or less than JCS10 after the first week of the onset
3.Cases to exceed either cut off level of SDS,Apathy score,SADQ-H10 or Vitality index
Key exclusion criteria
Contraindication of paroxetine/milnacipran/nicergoline/amantadine/bromocriptine
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatebayashi Kotaro |
Organization
Yuaikai Hospital
Division name
Neurosurgery
Zip code
Address
Hamaguchinishi3-5-1,suminoe-ku,osaka city,Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatebayashi Kotaro |
Organization
Yuaikai Hospital
Division name
Neurosurgery
Zip code
Address
Hamaguchinishi3-5-1,suminoe-ku,osaka city,Japan
TEL
Homepage URL
Sponsor or person
Institute
Yuaikai Hospital
Institute
Department
Personal name
Funding Source
Organization
No
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
| 2012 | Year | 07 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | 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
Management information
Registered date
| 2012 | Year | 07 | Month | 01 | Day |
Last modified on
| 2012 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009789
