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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030035
Receipt No. R000033958
Scientific Title Exploratory research for biomarkers related to Interpersonal Therapy
Date of disclosure of the study information 2017/11/30
Last modified on 2018/09/11

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Basic information
Public title Exploratory research for biomarkers related to Interpersonal Therapy
Acronym Exploratory research for biomarkers related to Interpersonal Therapy
Scientific Title Exploratory research for biomarkers related to Interpersonal Therapy
Scientific Title:Acronym Exploratory research for biomarkers related to Interpersonal Therapy
Region
Japan

Condition
Condition depressive disorders, bipolar and related disorders, anxiety disoredrs, post-traumatic stress disorder or feeding and eating disorders
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To explore the relationship between biomarkers assessed by brain MRI,endocrinology and metabolism examination and inflammation markers and psychosocial factors such as social support and clinical symptoms longitudinally and cross-sectionally on patients taken interpersonal therapy with diagnosis of depressive disorders, anxiety disorders, PTSD or eating disorders.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Beck Depression Inventory Second Edition
The Self report Version of the Panic Disorder Severity Scale
The Liebowitz Social Anxiety Scale Self Report
Posttraumatic Diagnostic Scale
Eating Disorder Inventory
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
16 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1. The Diagnosis is Depressive Disorders" or "Bipolar and Related Disorders" or "Anxiety Disoredrs" or "Post-traumatic stress disorder" or "Feeding and Eating disorders"for DSM-5. "Major Depressive Disorder", "Bipolar Disorder", "Panic Disorder", "Social Anxiety Disorder", "Post-traumatic Stress Disorder", "Anorexia Nervosa", "Bulimia Nervosa", "Binge Eating Disorder" and "General Anxiety Disorder" have to be assessed by The Mini-International Neuropsychiatric Interview(M.I.N.I.)7.0.0 .
2. The patients has signed an informed consent for intervention study of interpersonal psychotheapy in a month.
3. The patients who can be signed informed concent were enrolled in the present study.
Key exclusion criteria 1. The Diagnosis is "Schizophrenia Spectrum and Other Psychotic Disorders" or Obsessive-compulsive and Related Disorders" or "Cluster APersonality Disorders" or "Antisocial Personality Disorder" or "Neurodevelopmental Disorders" or "Neurocognitive disorders"
2. The patients who have active suicidal thought.
3. The patients who have any history of physical diseases or body condition that may prevent the study.
4.Patients who cannot be scanned with MRI safely because they has medical devices such as cardiac pacemakers, cochlear implants, or other metallic implants.
5. The patients who their research doctor consider not suited.



Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaki Kondo
Organization Nagoya City University
Division name Division of Psychiatry and Cognitive-Behavioral Medicine
Zip code
Address Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya
TEL 052-851-5511
Email kondo-masaki@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Risa Imai
Organization Nagoya City University
Division name Division of Psychiatry and Cognitive-Behavioral Medicine
Zip code
Address Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya
TEL 052-851-5511
Homepage URL
Email imai.r.nagoya@gmail.com

Sponsor
Institute Nagoya City University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
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
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
2017 Year 11 Month 30 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 Enrolling by invitation
Date of protocol fixation
2017 Year 12 Month 20 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We include patients who consented to the preceding intervention study(UMIN000022841) and conduct tests before and after treatment.
The method of the treatment intervention is stated in the preceding study protocol.

Test before treatment
Brain MRI
Blood test:metabolic functions, thyroid functions, vitamins, trace elements, ferritin

Test before and after treatment
Inflammation markers, cortisol
WCST:Wisconsin Card Sorting Test



Management information
Registered date
2017 Year 11 Month 20 Day
Last modified on
2018 Year 09 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033958

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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