UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030458 |
|---|---|
| Receipt number | R000034775 |
| Scientific Title | Prognosis study in patients underwent electroconvulsive therapy (ECT) |
| Date of disclosure of the study information | 2017/12/18 |
| Last modified on | 2019/12/20 10:52:25 |
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Basic information
Public title
Prognosis study in patients underwent electroconvulsive therapy (ECT)
Acronym
Prognosis of patients underwent ECT
Scientific Title
Prognosis study in patients underwent electroconvulsive therapy (ECT)
Scientific Title:Acronym
Prognosis of patients underwent ECT
Region
| Japan |
Condition
Condition
Severe or drug resistant major depressive disorder (MDD) with administration of initial electroconvulsive therapy (ECT)
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Association between the relapse of depressive episode and the subsequent diagnostic change in MDD patients underwent initial ECT
Basic objectives2
Others
Basic objectives -Others
Validation of clinical diagnosis
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Diagnostic change from MDD to bipolar disorder (BP) during the 3 years of followup period after receiving ECT
Key secondary outcomes
Relapse occurred during the 3 years of follow up period after receiving ECT
Period until relapse of depression after receiving ECT
Usage of remission maintenance therapy after receiving ECT
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 admitted to the Department of Psychiatry at the Shiga University of Medical Science Hospital between January 2009 and December 2011 whose diagnosis were met severe or drug registrant MDD criterion of DSM-IV-TR.
Patients who chose an antidepressant therapy at the time point of the remission despite of giving explanation of all treatment options including the C/M-ECT for maintaining remission.
Key exclusion criteria
Patients diagnosed as the other axis I and II disorders and neurologic illnesses, and having a history of ECT.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Kurimoto |
Organization
Shiga University of Medical Science
Division name
Department of Psychiatry
Zip code
520-2192
Address
Tukinowa-cho, Seta, Otsu, Shiga, 520-2192, Japan
TEL
077-548-2291
kurimoto@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Kurimoto |
Organization
Shiga University of Medical Science Hospital
Division name
Department of Psychiatry
Zip code
520-2192
Address
Tukinowa-cho, Seta, Otsu, Shiga, 525-0026, Japan
TEL
077-548-2111
Homepage URL
http://www.shiga-med.ac.jp/hospital/doc/ethics/files/1334.pdf
kurimoto@belle.shiga-med.ac.jp
Sponsor or person
Institute
Department of Psychiatry, Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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 IRB
Address
Tukinowa-cho, Seta, Otsu, Shiga, 520-2192, Japan
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
滋賀医科大学付属病院（滋賀県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 18 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 12 | Month | 22 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 30 | Day |
Other
Other related information
To investigate a diagnostic factor for facilitating a relapse following a first administration of ECT.
We investigate prognosis over 3 years in patients diagnosed with severe MDD, underwent initial course of ECT, and experienced remission under the naturalistic study regimen. We analyze the relationship between relapse with the diagnostic change from MDD to bipolar disorder after responding to initial administration of ECT.
Management information
Registered date
| 2017 | Year | 12 | Month | 18 | Day |
Last modified on
| 2019 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034775
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