UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047954 |
|---|---|
| Receipt number | R000054667 |
| Scientific Title | Long-Term Effects of Electroconvulsive Therapy on Cognitive Function |
| Date of disclosure of the study information | 2022/06/06 |
| Last modified on | 2022/06/05 16:55:33 |
* 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
Long-Term Effects of Electroconvulsive Therapy on Cognitive Function
Acronym
Long-Term Effects of Electroconvulsive Therapy on Cognitive Function
Scientific Title
Long-Term Effects of Electroconvulsive Therapy on Cognitive Function
Scientific Title:Acronym
Long-Term Effects of Electroconvulsive Therapy on Cognitive Function
Region
| Japan |
Condition
Condition
Depression, bipolar disorder, schizophrenia, schizoaffective disorder
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test whether ECT has long-term protective effects on cognitive function.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
BACS score at least 6 months after the last ECT
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
1, Those who have already been clinically scheduled to receive ECT at the time of obtaining consent for this study, or have been judged by their attending physician to be eligible for ECT, or have received ECT in the past.
2, Those who have met the diagnostic criteria for depression, bipolar disorder, schizophrenia, schizoaffective disorder, etc.
3, 20 years of age or older
Key exclusion criteria
1, Those with a history of head trauma with consciousness disorder in the past
2, Those who admit antisocial personality disorder
3, Those with a clinical diagnosis of life-threatening or unstable physical or cerebral organic disease
4, Patients with pacemakers, aneurysm clips, artificial valves, cochlear implants, or other magnetic or electrically conductive metals that make them unsuitable for MRI imaging
5,Those who are unable to enter the MRI due to claustrophobia
6,Those who are deemed inappropriate as subjects of this study by the Principal Investigator or co-principal Investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Jinichi |
| Middle name | |
| Last name | Hirano |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3971
hjinichi@gmail.com
Public contact
Name of contact person
| 1st name | Jinichi |
| Middle name | |
| Last name | Hirano |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3971
Homepage URL
hjinichi@gmail.com
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
03-5363-3971
hjinichi@gmail.com
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
| 2022 | Year | 06 | Month | 06 | 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
| 2022 | Year | 02 | Month | 08 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cognitive function tests are performed at least 6 months after the last ECT is performed. In addition, various psychological tests, head MRI, and blood tests are performed to evaluate psychiatric symptoms.
Management information
Registered date
| 2022 | Year | 06 | Month | 06 | Day |
Last modified on
| 2022 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054667
