UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030458
Receipt No. R000034775
Scientific Title Prognosis study in patients underwent electroconvulsive therapy (ECT)
Date of disclosure of the study information 2017/12/18
Last modified on 2019/06/25

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email kurimoto@belle.shiga-med.ac.jp

Sponsor
Institute Department of Psychiatry, Shiga University of Medical Science
Institute
Department

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
Email 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 06 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034775

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.