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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000045649
Receipt No. R000052114
Scientific Title Assessment of depressive disorders based on neuroinflammatory mechanisms using quantitative index of thermal pain perception
Date of disclosure of the study information 2021/10/04
Last modified on 2021/10/04

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Basic information
Public title Assessment of depressive disorders based on neuroinflammatory mechanisms using quantitative index of thermal pain perception
Acronym Assessment of depressive disorders based on the thermal pain perception index
Scientific Title Assessment of depressive disorders based on neuroinflammatory mechanisms using quantitative index of thermal pain perception
Scientific Title:Acronym Assessment of depressive disorders based on the thermal pain perception index
Region
Japan

Condition
Condition Depressive disorders
Other psychiatric disorders
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to quantify intrinsic pain control (placebo analgesia), which reflects reward system reserve, as a behavioral index in patients with depression and other psychiatric disorders, and to examine its relationship with neuroinflammatory and functional and structural neural indices. At the same time, we will examine the impact of chronic insomnia on intrinsic pain control and clarify its significance for the development and maintenance of depression and chronic insomnia. This will be a preliminary study to explore new methods of assessing depression that may contribute to differentiating it from other psychiatric disorders, and to conduct research aimed at developing new differential diagnoses as markers of biological characteristics of depression.
Basic objectives2 Others
Basic objectives -Others Identification of biological indicators
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cold and warm detection thresholds (CDT, WDT) and cold and heat pain thresholds (CPT, HPT) measured using Quantitative Sensory Testing: QST
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) Patients who are 20 years old or older at the time of obtaining informed consent
(2) Patients with insomnia, or anxiety and depression (based on the assessment by physician)
(3) Patients who can understand the explanatory document of the study and can give written consent of their own free will.
Key exclusion criteria (1) Patients with serious suicidal ideation and imminent suicide attempt
(2) Patients with a history of substance abuse within 3 months prior to the date of consent
(3) Patients with severe pain, acute trauma, or peripheral nerve paralysis in the forearm of the non-dominant hand for any reason
(4) Other patients who have been considered inappropriate for participation in the study by the physicians involved in this study
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Yuji
Middle name
Last name Ozeki
Organization Shiga University of Medical Science
Division name Department of Psychiatry
Zip code 520-2192
Address Tsukinowa-cho, Seta, Otsu-city, Shiga
TEL 077-548-2291
Email ozeki@belle.shiga-med.ac.jp

Public contact
Name of contact person
1st name Atsushi
Middle name
Last name Yoshimura
Organization Shiga University of Medical Science
Division name Department of Psychiatry
Zip code 520-2192
Address Tsukinowa-cho, Seta, Otsu-city, Shiga
TEL 077-548-2291
Homepage URL
Email atusi@belle.shiga-med.ac.jp

Sponsor
Institute Shiga University of Medical Science
Institute
Department

Funding Source
Organization Self funding
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 Shiga University of Medical Science Ethics Examination Office
Address Tsukinowa-cho, Seta, Otsu-city, Shiga
Tel 077-548-3576
Email hqrec@belle.shiga-med.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
2021 Year 10 Month 04 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 Preinitiation
Date of protocol fixation
2021 Year 10 Month 04 Day
Date of IRB
Anticipated trial start date
2021 Year 11 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To clarify the relationship between thermal pain thresholds/placebo effects and psychiatric symptoms such as depression and insomnia.

Management information
Registered date
2021 Year 10 Month 04 Day
Last modified on
2021 Year 10 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052114

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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