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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034678
Receipt No. R000039533
Official scientific title of the study 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 2018/10/29

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Basic information
Official scientific title of the study Gluten sensitivity among the patients with depression and the possibility of therapeutic effect of gluten free diet
Title of the study (Brief title) 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 Yamada Hisashi
Organization hyogo college of medicine
Division name department of psychiatry
Address 1-1, mukogawatyo, nisinomiya city, hyogo
TEL 0798-45-6051
Email hisa0820@hyo-med.ac.jp

Public contact
Name of contact person Yamada Hisashi
Organization hyogo college of medicine
Division name department of psychiatry
Address 1-1, mukogawatyo, nisinomiya city, hyogo
TEL 0798-45-6051
Homepage URL
Email hisa0820@hyo-med.ac.jp

Sponsor
Institute hyogo college of medicine department of psychiatry
Institute
Department

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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 12 Month 01 Day
Anticipated trial start date
2018 Year 12 Month 01 Day
Last follow-up date
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
2018 Year 10 Month 29 Day
Last modified on
2018 Year 10 Month 29 Day


Link to view the page
URL(English) https://upload.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


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