UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024392 |
|---|---|
| Receipt number | R000028055 |
| Scientific Title | Glutamate and Antipsychotic Treatment Response in Patients with Schizophrenia: a Cross-Sectional Multimodal MRI Study |
| Date of disclosure of the study information | 2016/10/17 |
| Last modified on | 2023/04/23 12:57:17 |
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Basic information
Public title
Glutamate and Antipsychotic Treatment Response in Patients with Schizophrenia: a Cross-Sectional Multimodal MRI Study
Acronym
Glutamate and Antipsychotic Treatment Response in Patients with Schizophrenia
Scientific Title
Glutamate and Antipsychotic Treatment Response in Patients with Schizophrenia: a Cross-Sectional Multimodal MRI Study
Scientific Title:Acronym
Glutamate and Antipsychotic Treatment Response in Patients with Schizophrenia
Region
| Japan |
Condition
Condition
Schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Not translated yet
Basic objectives2
Others
Basic objectives -Others
Not translated yet
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Not translated yet
Key secondary outcomes
Not translated yet
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Magnetic Resonance Imaging (45 minutes)
-T1 (5)
-Proton Magnetic Resonance Spectroscopy (10)
-Diffusion Tensor Imaging (15)
-Resting-state functional Magnetic Resonance Imaging (15)
Electroencephalography (15)
Interventions/Control_2
Magnetic Resonance Imaging (45 minutes)
-T1 (5)
-Proton Magnetic Resonance Spectroscopy (10)
-Diffusion Tensor Imaging (15)
-Resting-state functional Magnetic Resonance Imaging (15)
Electroencephalography (15)
Interventions/Control_3
Magnetic Resonance Imaging (45 minutes)
-T1 (5)
-Proton Magnetic Resonance Spectroscopy (10)
-Diffusion Tensor Imaging (15)
-Resting-state functional Magnetic Resonance Imaging (15)
Electroencephalography (15)
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
Not translated yet
Key exclusion criteria
Not translated yet
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Shinichiro |
| Middle name | |
| Last name | Nakajima |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-0016
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582 Japan
TEL
03-3353-1211(61857)
shinichiro_nakajima@hotmail.com
Public contact
Name of contact person
| 1st name | Nakajima |
| Middle name | |
| Last name | Shinichiro |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-0016
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582 Japan
TEL
03-3353-1211(61857)
Homepage URL
shinichiro_nakajima@hotmail.com
Sponsor or person
Institute
Keio University School of Medicine
Department of Neuropsychiatry
Institute
Department
Personal name
Funding Source
Organization
Not translated yet
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Komagino Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Department of Neuropsychiatry
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582 Japan
Tel
03-3353-1211(61857)
shinichiro.l.nakajima@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
慶應義塾大学医学部精神・神経科学教室
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 17 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000028055
Publication of results
Published
Result
URL related to results and publications
https://koara.lib.keio.ac.jp/xoonips/modules/xoonips/detail.php?koara_id=KAKEN_16H06253seika
Number of participants that the trial has enrolled
95
Results
A total of 95 participants were included (TRS=29, non-TRS=33, and HCs=33). dACCGlx levels were higher in the TRS group versus HCs. No group differences were identified in the caudate. Our results suggest that higher Glx levels in the dACC may reflect the difference indisease category between TRS and non-TRS.
Results date posted
| 2023 | Year | 04 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Not translation yet
Participant flow
Not translation yet
Adverse events
Not adverse events
Outcome measures
Not translation yet
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 10 | Month | 17 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 06 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 13 | Day |
Last modified on
| 2023 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028055
