UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024374 |
|---|---|
| Receipt number | R000028043 |
| Scientific Title | Changes in trace substances in peripheral blood following electroconvulsive therapy in patients with depression: a longitudinal observational study |
| Date of disclosure of the study information | 2016/10/17 |
| Last modified on | 2023/04/18 16:34:48 |
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Basic information
Public title
Changes in trace substances in peripheral blood following electroconvulsive therapy in patients with depression: a longitudinal observational study
Acronym
Changes in trace substances in blood following electroconvulsive therapy
Scientific Title
Changes in trace substances in peripheral blood following electroconvulsive therapy in patients with depression: a longitudinal observational study
Scientific Title:Acronym
Changes in trace substances in blood following electroconvulsive therapy
Region
| Japan |
Condition
Condition
1. Inpatients with major depressive disorder
2. Healthy controls.
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine changes in trace substances in peripheral blood following electroconvulsive therapy, using metabolomics with mass spectrometry, in patients with depression.
Basic objectives2
Others
Basic objectives -Others
To screen biological markers for depression.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in trace substances in peripheral blood following electroconvulsive therapy.
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
[Patients with depression]
1) Inpatients at Department of Neuropsychiatry, Keio University Hospital.
2) Major depressive disorder according to DSM5.
3) Twenty years or older of age and being capable of providing consent or presence of substitute decision maker.
4) Being supposed to receive ECT and/or antidepressant treatment.
[Healthy controls]
1) Volunteers who was matched age and gender to the patients with major depressive disorder who receive electroconvulsive therapy.
2) No presence of any psychiatry diagnosis.
3) No presence of psychiatry history.
4) Twenty years or older of age and being capable of providing consent.
Key exclusion criteria
[Patients with depression]
1) Presence of unstable physical illness.
2) History of electroconvulsive therapy for the past 6 months.
3) History of alcohol or any substance abuse for the past 6 months.
4) History of head trauma accompanied with severe neurological aftereffects.
5) History of vagal reflex induced by blood draw.
[Healthy controls]
1) Presence of unstable physical illness.
2) History of vagal reflex induced by blood draw.
3) Those who are involved in this research.
4) Those who are exposed to potential pressure from investigators.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Uchida |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo,160-8582, Japan.
TEL
03-5363-3829
hiroyuki.uchida.hu@gmail.com
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Uchida |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.
TEL
03-5363-3829
Homepage URL
hiroyuki.uchida.hu@gmail.com
Sponsor or person
Institute
Department of Neuropsychiatry, Keio University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Neuropsychiatry, Keio University, School of Medicine
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
Keio University School of Medicine Ethics Committee.
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.
Tel
03-5363-3503
med-rinri-jimu@adst.keio.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
| 2016 | Year | 10 | Month | 17 | 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
| 2016 | Year | 10 | Month | 03 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To examine changes in trace substances in peripheral blood following electroconvulsive therapy, using metabolomics with mass spectrometry, in patients with depression.
Management information
Registered date
| 2016 | Year | 10 | Month | 12 | Day |
Last modified on
| 2023 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028043
