UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034678
Receipt number R000039533
Scientific Title Gluten sensitivity among the patients with depression and the possibility of therapeutic effect of gluten free diet
Date of disclosure of the study information 2018/12/01
Last modified on 2020/11/02 11:52:14

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Basic information

Public title

Gluten sensitivity among the patients with depression and the possibility of therapeutic effect of gluten free diet

Acronym

Gluten sensitivity among the patients with depression and the possibility of therapeutic effect of gluten free diet

Scientific Title

Gluten sensitivity among the patients with depression and the possibility of therapeutic effect of gluten free diet

Scientific Title:Acronym

Gluten sensitivity among the patients with depression and the possibility of therapeutic effect of gluten free diet

Region

Japan


Condition

Condition

depression

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the gluten sensitivity and its relationships between symptoms , severity, and drugs responsibility among the patients with depression in Japan and effectiveness of gluten free diet for the depression patients with gluten sensitivity.

Basic objectives2

Others

Basic objectives -Others

To measure the antibody related to gluten sensitivity with the plasma obtained from the patients with depression.
To investigate the effectiveness of gluten free diet for the depression patients with gluten sensitivity, open trail with gluten free diet for two weeks is performed.

Trial characteristics_1

Confirmatory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Assessment of gluten sensitivity is determined by the titer of tissue transglutaminase IgA antibody, the deamidated gliadin peptide IgA antibody, gliadin IgA antibody, gliadin IgGa nti body.

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

Food

Interventions/Control_1

gluten sensitive patients with depression have gluten free diet for two weeks. Patients whose symptoms are improved (Score decrease twenty percents or CGI-I score above three at two weeks) continue gluten free diet for eight weeks.

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

70 years-old >=

Gender

Male and Female

Key inclusion criteria

patient who met the criteria of depression in the DSM-5
patient who can understand the purpose of this study and be approved to participate by doctor
patient who can provide written informed consent

Key exclusion criteria

patient with remarkable excitement, violent action, self-injurious behavior
patient with social behavior
patinet who can't provide written informed consent
patient who have substance abuse or dependent

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yamada Hisashi

Organization

hyogo college of medicine

Division name

department of psychiatry

Zip code


Address

1-1, mukogawatyo, nisinomiya city, hyogo

TEL

0798-45-6051

Email

hisa0820@hyo-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yamada Hisashi

Organization

hyogo college of medicine

Division name

department of psychiatry

Zip code


Address

1-1, mukogawatyo, nisinomiya city, hyogo

TEL

0798-45-6051

Homepage URL


Email

hisa0820@hyo-med.ac.jp


Sponsor or person

Institute

hyogo college of medicine department of psychiatry

Institute

Department

Personal name



Funding Source

Organization

hyogo college of medicine department of psychiatry

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


Email



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

2018 Year 12 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

Completed

Date of protocol fixation

2018 Year 12 Month 01 Day

Date of IRB

2018 Year 12 Month 01 Day

Anticipated trial start date

2018 Year 12 Month 01 Day

Last follow-up date

2020 Year 09 Month 30 Day

Date of closure to data entry

2020 Year 09 Month 30 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 10 Month 29 Day

Last modified on

2020 Year 11 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039533


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name