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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024392
Receipt No. 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 2019/05/25

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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)
Email 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
Email shinichiro_nakajima@hotmail.com

Sponsor
Institute Keio University School of Medicine
Department of Neuropsychiatry
Institute
Department

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)
Email 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
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
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
2019 Year 05 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028055

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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