UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The possibility of 5-HIAA,serotonin metabolites, as a biomaker of depressed COPD patients.
Title of the study (Brief title)	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	Kurosawa Hajime
Organization	Tohoku university graduate school of medicine
Division name	department of occupational medicine
Address	2-1,seiryo-machi, aoba-ku,sendai-shi,Miyagi 980-8575,Japan
TEL	022-717-7874
Email	10mr0bins0n@gmail.com

Public contact
Name of contact person	Miura Emiri
Organization	Tohoku university graduate school of medicine
Division name	department of occupational medicine
Address	2-1,seiryo-machi, aoba-ku,sendai-shi,Miyagi 980-8575,Japan
TEL	022-717-7874
Homepage URL
Email	10mr0bins0n@gmail.com

Sponsor
Institute	Tohoku university graduate school of medicine
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 01 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024595