UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036732
Receipt No. R000041220
Scientific Title A longitudinal study of stress tolerance related to regional brain volume change based on deep emotion
Date of disclosure of the study information 2019/06/01
Last modified on 2019/05/13

* 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 A longitudinal study of stress tolerance related to regional brain volume change based on deep emotion
Acronym A study of stress tolerance and brain volume change with deep emotion
Scientific Title A longitudinal study of stress tolerance related to regional brain volume change based on deep emotion
Scientific Title:Acronym A study of stress tolerance and brain volume change with deep emotion
Region
Japan

Condition
Condition depression, reaction to severe stress, and adjustment disorders
Classification by specialty
Psychiatry Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To demonstrate the relation between regional brain change based on deep emotion and stress tolerance.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes At start, 6 months later, and 1 year later of absent from work because of illness.
Key secondary outcomes At time of reinstatement.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 3 times MRI scans at sick leave, 6 months later, and 1 year later.
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
60 years-old >=
Gender Male and Female
Key inclusion criteria Patients with depression, reaction to severe stress, or adjustment disorder using ICD10 at sick leave.
Key exclusion criteria Patients who have contraindication to MRI.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Seishu
Middle name
Last name Nakagawa
Organization Tohoku Medical and Pharmaceutical University
Division name Psychiatry
Zip code 983-8536
Address Fukumuro, Miyagino-ku, 1-15-11, Sendai, Miyagi
TEL 0222591221
Email seishu@tohoku-mpu.ac.jp

Public contact
Name of contact person
1st name Seishu
Middle name
Last name Nakagawa
Organization Tohoku Medical and Pharmaceutical University
Division name Psychiatry
Zip code 983-8536
Address Fukumuro, Miyagino-ku, 1-15-11, Sendai, Miyagi
TEL 0222591221
Homepage URL
Email seishu@tohoku-mpu.ac.jp

Sponsor
Institute Division of Psychiatry, Tohoku Medical and Pharmaceutical University
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Institute of Development, Aging and Cancer, Tohoku University
Name of secondary funder(s)

IRB Contact (For public release)
Organization Independent Ethics Committee of Tohoku Medical and Pharmaceutical University Hospital
Address Fukumuro, Miyagino-ku, 1-12-1, Sendai, Miyaagi
Tel 022-259-1221
Email tikenn@hosp.tohoku-mpu.ac.jp

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
2019 Year 06 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 Preinitiation
Date of protocol fixation
2018 Year 12 Month 13 Day
Date of IRB
Anticipated trial start date
2019 Year 07 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 05 Month 13 Day
Last modified on
2019 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041220

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.