UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033061 |
|---|---|
| Receipt number | R000037697 |
| Scientific Title | Assessment of physiological measures including heart rate variability for objectively evaluating symptoms in depression and other psychiatric disorders |
| Date of disclosure of the study information | 2018/07/01 |
| Last modified on | 2025/02/13 19:04:47 |
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Basic information
Public title
Assessment of physiological measures including heart rate variability for objectively evaluating symptoms in depression and other psychiatric disorders
Acronym
Psyciatric symptom evaluation using physiological measures
Scientific Title
Assessment of physiological measures including heart rate variability for objectively evaluating symptoms in depression and other psychiatric disorders
Scientific Title:Acronym
Psyciatric symptom evaluation using physiological measures
Region
| Japan |
Condition
Condition
depression, anxiety disorder, bipolar disorder, adjustment disorder, schizophrenia, dementia, delirium, autisum spectrum disorder, attention deficit/hyperactive disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study intends to verify the usfulness of autonomic measures including heart rate variability, skin conductance, body temparature, and blood pressure and central measures including electroencephalogram and cerebral blood flow for evaluating symptoms in psychiatric disorders including depression.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Usefulness of physiological measures will be evaluated in 5 years using data from about 100 subjecets.
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
Heart rate variability measurement, skin conductance measurement, body tenmarature measurement, body movement measurement, blood pressure measurement, electroencephalography, near-infrared spectroscopy
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
| 12 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The subjects with psychiatric disorders are icluded.
Key exclusion criteria
Diabetes Mellitus and arrhythimnic patients are excluded.
Target sample size
100
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-shi
TEL
054-285-6171
t156591@siz.saiseikai.or.jp
Public contact
Name of contact person
| 1st name | Toshikazu |
| Middle name | |
| Last name | Shinba |
Organization
Shiuoka Saiseikai General Hospital
Division name
Department of Psychiatry
Zip code
422-8527
Address
1-1-1 Oshika, Suruga-ku, Shizuoka-shi
TEL
054-285-6171
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
Department of Psychiatry
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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, 422-8527 Japan
Tel
054-285-6171
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
| 2018 | Year | 07 | Month | 01 | 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
| 2018 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | 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
| 2018 | Year | 06 | Month | 20 | Day |
Last modified on
| 2025 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037697
