UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030035 |
|---|---|
| Receipt number | R000033958 |
| Scientific Title | Exploratory research for biomarkers related to Interpersonal Therapy |
| Date of disclosure of the study information | 2017/11/30 |
| Last modified on | 2021/12/11 10:09:06 |
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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
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
imai.r.nagoya@gmail.com
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2017 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 19 | 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
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
| 2021 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033958
