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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008312
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Yuaikai Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009789

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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