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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035301
Receipt No. R000040220
Scientific Title Monoamine metabolite levels in schizophrenia correlate with mismatch negativity
Date of disclosure of the study information 2018/12/19
Last modified on 2018/12/18

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Basic information
Public title Monoamine metabolite levels in schizophrenia correlate with mismatch negativity
Acronym Monoamine metabolite in schizophrenia correlates with MMN
Scientific Title Monoamine metabolite levels in schizophrenia correlate with mismatch negativity
Scientific Title:Acronym Monoamine metabolite in schizophrenia correlates with MMN
Region
Japan

Condition
Condition Schizphrenia
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The principal aim of this study is to reveal the relation between mismatch negativity and monoamine levels in patients with schizophrenia.
Basic objectives2 Others
Basic objectives -Others None
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation between amplitude of mismatch negativity and level of homovanillic acid (HVA) and 5-hydroxyindole acetic acid (5-HIAA) collected from patients' serum.
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 Japanese patients diagnosed with schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. All participants are right-handed and undergoing medical treatment with antipsychotic drugs.
Key exclusion criteria None reported any neurological disorder, hearing dysfunction, traumatic brain injury, or previous substance abuse or addiction.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shiga Tetsuya
Organization Fukushima Medical University
Division name Department of Neuropsychiatry
Zip code
Address 1 Hikarigaoka, Fukushima City
TEL 0245471331
Email tetsuya3@fmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shiga Tetsuya
Organization Fukushima Medical University
Division name Department of Neuropsychiatry
Zip code
Address 1 Hikarigaoka, Fukushima City
TEL 0245471331
Homepage URL
Email tetsuya3@fmu.ac.jp

Sponsor
Institute Fukushima Medical University
Institute
Department

Funding Source
Organization Fukushima Medical University
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
Address
Tel
Email

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
2018 Year 12 Month 19 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 Completed
Date of protocol fixation
2013 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 04 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 Relationships between MMN and plasma monoamine levels

Management information
Registered date
2018 Year 12 Month 18 Day
Last modified on
2018 Year 12 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040220

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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