UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025307
Receipt number R000028386
Scientific Title Identification of biomarkers for diagnosis of major depression
Date of disclosure of the study information 2017/01/01
Last modified on 2022/12/22 09:36:48

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Basic information

Public title

Identification of biomarkers for diagnosis of major depression

Acronym

Identification of biomarkers of depression

Scientific Title

Identification of biomarkers for diagnosis of major depression

Scientific Title:Acronym

Identification of biomarkers of depression

Region

Japan


Condition

Condition

Major depressive disorder

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Examining the effect of exercise therapy on depression and salivary levels of cortisol, alpha-amylase, and cytokines.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Hamilton depression rating scale, Montgomery-Asberg Depression Rating Scale, and salivary levels of cortisol, alpha-amylase, and cytokines.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Eight weeks of exercise therapy

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Major depression group:
Adults diagnosed as major depressive disorder

Control group:
Adults not diagnosed as major depressive disorder

Key exclusion criteria

1. Suffers from any inflammatory, endocrine, or metabolic disorders or suffers from severe periodontal disease.
2. Has taken anti-allergic medication, steroid, or immunosuppressant medication in the past month.
3. Suffers from organic brain disease.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Daimei
Middle name
Last name Sasayama

Organization

Shinshu University School of Medicine

Division name

Department of Psychiatry

Zip code

390-8621

Address

3-1-1 Asahi, Matsumoto

TEL

0263372638

Email

sasayama@shinshu-u.ac.jp


Public contact

Name of contact person

1st name Daimei
Middle name
Last name Sasayama

Organization

Shinshu University School of Medicine

Division name

Department of Psychiatry

Zip code

390-8621

Address

3-1-1 Asahi, Matsumoto

TEL

0263372638

Homepage URL


Email

sasayama@shinshu-u.ac.jp


Sponsor or person

Institute

Shinshu University

Institute

Department

Personal name



Funding Source

Organization

Shinshu University

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

Shinshu University School of Medicine Medical Ethics Committee

Address

3-1-1 Asahi, Matsumoto

Tel

0263-37-2572

Email

mdrinri@shinshu-u.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

2017 Year 01 Month 01 Day


Related information

URL releasing protocol

https://www.sciencedirect.com/science/article/pii/S0303846722002712?via%3Dihub

Publication of results

Published


Result

URL related to results and publications

https://www.sciencedirect.com/science/article/pii/S0303846722002712?via%3Dihub

Number of participants that the trial has enrolled

69

Results

The salivary levels of IL-1beta, IL-6, IL-9, IL-12p70, IL-13, Chemokine CCL11 (Eotaxin), MIP-1alpha, RANTES, and VEGF were significantly higher in patients than controls. IL-1beta, IL-12p70, CCL11, and VEGF remained significant after controlling for possible confounding factors.

Results date posted

2022 Year 12 Month 22 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

19 patients with MDD and 50 healthy controls

Participant flow

The levels of 27 cytokines in saliva were measured by multiplex bead array assay.

Adverse events

None

Outcome measures

Salivary cytokine levels

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 12 Month 06 Day

Date of IRB

2016 Year 12 Month 06 Day

Anticipated trial start date

2017 Year 01 Month 01 Day

Last follow-up date

2021 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

2016 Year 12 Month 17 Day

Last modified on

2022 Year 12 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028386


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name