UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021326 |
|---|---|
| Receipt number | R000024595 |
| Scientific Title | The possibility of 5-HIAA,serotonin metabolites, as a biomaker of depressed COPD patients. |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2018/03/05 09:17:02 |
* 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
The possibility of 5-HIAA,serotonin metabolites, as a biomaker of depressed COPD patients.
Acronym
The possibility of 5-HIAA,serotonin metabolites, as a biomaker of depressed COPD patients.
Scientific Title
The possibility of 5-HIAA,serotonin metabolites, as a biomaker of depressed COPD patients.
Scientific Title:Acronym
The possibility of 5-HIAA,serotonin metabolites, as a biomaker of depressed COPD patients.
Region
| Japan |
Condition
Condition
copd and depression
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate that positive association between the plasma levels of 5-HIAA and severity of depression with COPD patients
before and after respiratory rehabilitation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
the plasma levels of 5-HIAA before and after respiratory rehabilitation
Key secondary outcomes
score of CES-D before and after respiratory rehabilitation
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
respiratory rehabilitation for three months
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
stable COPD patients
Key exclusion criteria
depressed COPD patients by under medical treatment
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kurosawa Hajime |
Organization
Tohoku university graduate school of medicine
Division name
department of occupational medicine
Zip code
Address
2-1,seiryo-machi, aoba-ku,sendai-shi,Miyagi 980-8575,Japan
TEL
022-717-7874
10mr0bins0n@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miura Emiri |
Organization
Tohoku university graduate school of medicine
Division name
department of occupational medicine
Zip code
Address
2-1,seiryo-machi, aoba-ku,sendai-shi,Miyagi 980-8575,Japan
TEL
022-717-7874
Homepage URL
10mr0bins0n@gmail.com
Sponsor or person
Institute
Tohoku university graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
Tohoku university graduate school of medicine
Organization
Division
Category of Funding Organization
Other
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 | 04 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 01 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 03 | Day |
Last modified on
| 2018 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024595
