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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024374
Receipt No. 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 2019/04/15

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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
Email hiroyuki.uchida.hu@gmail.com

Public contact
Name of contact person
1st name Takahito
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
Email takahito3332001@yahoo.co.jp

Sponsor
Institute Department of Neuropsychiatry, Keio University, School of Medicine
Institute
Department

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
Email 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 Enrolling by invitation
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
2020 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
2019 Year 04 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028043

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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