UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045649 |
|---|---|
| Receipt number | 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 | 2025/04/08 15:03:30 |
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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
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
atusi@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
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
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
Terminated
Date of protocol fixation
| 2021 | Year | 10 | Month | 04 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 26 | Day |
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
| 2025 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052114
