UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058055 |
|---|---|
| Receipt number | R000066357 |
| Scientific Title | Pathophysiological evaluation of bipolar disorder and depression using autonomic, EEG and cerebral blood flow measurements |
| Date of disclosure of the study information | 2025/06/02 |
| Last modified on | 2025/06/02 16:43:32 |
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Basic information
Public title
Pathophysiological evaluation of bipolar disorder and depression using autonomic, EEG and cerebral blood flow measurements
Acronym
Pathophysiological evaluation of bipolar disorder and depression using physiological indices
Scientific Title
Pathophysiological evaluation of bipolar disorder and depression using autonomic, EEG and cerebral blood flow measurements
Scientific Title:Acronym
Pathophysiological evaluation of bipolar disorder and depression using physiological indices
Region
| Japan |
Condition
Condition
bipolar disorder, depression, anxiety disorder, adjustment disorder, neurodevelopmental disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The subjects with bipolar disorder exhibit depressed mood during their depressive episode, making it difficult to differentiate from major depressive disorder. Differential diagnosis is important because the treatment strategy is different depending on the diagnosis. Development of biomarkers has been investigated and the present study focus on the physiological markers including autonomic, EEG, and cerebral blood flow indices.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Heart rate, heart rate variability, skin conductance, skin temperature are used as autonomic indices. Power spectrum analysis of EEG data was conducted to evaluate brain electrical activity. Brain blood flow was calculated at the forehead. The pathophysiological profiles of the disorders at rest as well as during mental tasks are evaluated using these indices.
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
The sensors include a wearable ECG sensor placed on the chest (RF-ECG2, GM3 Co.), a wrist-band-type autonomic measurement device around the wrist (Embrace-Plus, Empatica Co.), a wearable EEG and autonomic measurement system on the head surface (MWM-20, GMS Co.). a skin conductance measurement device (Bioderm, UFI Co.). and time-resolved near-infrared spectroscopy at the forehead (TRS-10, Hamamatsu Photonics). The indices are measured during the rest state as well as during some activities, including mental tasks.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients who visit the department of psychiatry at Shizuoka Saiseikai General Hospital are recruited to this study after giving us their consent to participate in it.The protocol of this study has been approved by the Institutional Review Board of Shizuoka Saiseikai General Hospital.
Key exclusion criteria
Those who have somatic disorders that do not allow the stable measurement are excluded. The patients who show adverse effects due to the measurement are also excluded.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Toshikazu |
| Middle name | |
| Last name | Shinba |
Organization
Shizuoka Saiseikai General Hospital
Division name
Department of Psychiatry
Zip code
422-8527
Address
1-1-1 Oshika, Suruga-ku, Shizuoka, Japan
TEL
+81542856171
t156591@siz.saiseikai.or.jp
Public contact
Name of contact person
| 1st name | Toshikazu |
| Middle name | |
| Last name | Shinba |
Organization
Shizuoka Saiseikai General Hospital
Division name
Department of Psychiatry
Zip code
422-8527
Address
1-1-1 Oshika, Suruga-ku, Shizuoka, Japan
TEL
+81542856171
Homepage URL
t156591@siz.saiseikai.or.jp
Sponsor or person
Institute
Shizuoka Saiseikai General Hospital
Institute
Department
Personal name
Funding Source
Organization
Shizuoka Saiseikai General Hospital
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shizuoka Saiseikai General Hospital
Address
1-1-1 Oshika, Suruga-ku, Shizuoka, Japan
Tel
0542856171
t156591@siz.saiseikai.or.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
| 2025 | Year | 06 | Month | 02 | 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
| 2013 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2013 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2013 | Year | 03 | Month | 25 | Day |
Last follow-up date
| 2035 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 02 | Day |
Last modified on
| 2025 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066357
