UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036732
Receipt number 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 2022/11/14 12:08:22

* 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 absent from work because of illness or lower performance than usual in work place and 6 months later.

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

Two times MRI scans at sick leave or lower performance than usual in work place and 6 months 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 or person

Institute

Division of Psychiatry, Tohoku Medical and Pharmaceutical University

Institute

Department

Personal name



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


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

東北医科薬科大学病院 Tohoku Medical and Pharmaceutical University Hospital


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

none

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

2019 Year 05 Month 27 Day

Anticipated trial start date

2020 Year 02 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

We have recruited 20 patients for this research.


Management information

Registered date

2019 Year 05 Month 13 Day

Last modified on

2022 Year 11 Month 14 Day



Link to view the page

Value
https://center6.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