UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013877 |
|---|---|
| Receipt number | R000016188 |
| Scientific Title | Investigation of glucose metabolism and neural substrates in patients with schizophrenia and mood disorder with ECT |
| Date of disclosure of the study information | 2014/05/02 |
| Last modified on | 2018/05/07 10:59:37 |
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Basic information
Public title
Investigation of glucose metabolism and neural substrates in patients with schizophrenia and mood disorder with ECT
Acronym
Investigation of glucose metabolism and neural substrates in patients with schizophrenia and mood disorder with ECT
Scientific Title
Investigation of glucose metabolism and neural substrates in patients with schizophrenia and mood disorder with ECT
Scientific Title:Acronym
Investigation of glucose metabolism and neural substrates in patients with schizophrenia and mood disorder with ECT
Region
| Japan |
Condition
Condition
Schizophrenia, mood disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the effect of ECT on glucose metabolism and neural substrates in schizophrenia and mood disorder.
Basic objectives2
Others
Basic objectives -Others
Elucidation of healing mechanism
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes of structural and functional neural substrates, glucose metabolism, and symptomatology.
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
| 17 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants who meet the criteria for schizophrenia or mood disorder according to the Structured Clinical Interview for DSM-IV Axis I Disorders.
-Participants who are treated with ECT.
-Participants who are treated with medication.
Key exclusion criteria
Those with past history of psychiatric or neuronal diseases.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taro Suwa |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Psychiatry
Zip code
Address
54 Shogoin-Kawaharacho, Sakyo-ku, Kyoto 606-8507, JAPAN
TEL
0757513383
tarosuwa@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taro Suwa |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Psychiatry
Zip code
Address
54 Shogoin-Kawaharacho, Sakyo-ku, Kyoto 606-8507, JAPAN
TEL
0757513383
Homepage URL
tarosuwa@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Psychiatry, Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 05 | Month | 02 | 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
| 2014 | Year | 05 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluating the effect of ECT on glucose metabolism and neural substrates in schizophrenia and mood disorder.
Management information
Registered date
| 2014 | Year | 05 | Month | 02 | Day |
Last modified on
| 2018 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016188
