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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000023977
Receipt No. R000027576
Scientific Title Neurocognitive functions, social functions and decision making in schizophrenia patients comparing with healthy subjects
Date of disclosure of the study information 2016/09/08
Last modified on 2016/09/08

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Basic information
Public title Neurocognitive functions, social functions and decision making in schizophrenia patients comparing with healthy subjects
Acronym Neurocognitive functions, social functions and decision making in schizophrenia patients comparing with healthy subjects
Scientific Title Neurocognitive functions, social functions and decision making in schizophrenia patients comparing with healthy subjects
Scientific Title:Acronym Neurocognitive functions, social functions and decision making in schizophrenia patients comparing with healthy subjects
Region
Japan

Condition
Condition schizophrenia
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 We are investigating in neurocognitive functions, social functions and a tendency of decision making, also comparing among the schizophrenia patients recovered from the illness, the refractory schizophrenia patients and healthy subjects.
Basic objectives2 Others
Basic objectives -Others We are also investigating side effects with treatments.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Cognitive function test (COGNITRAX)
Social Functioning Scale(SFS)
The prisoner's dilemma game
The ultimatum game
Key secondary outcomes Japanese Adult Reading Test
Drug Induced Extra-Pyramidal Symptons Scale(DIEPSS)

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
65 years-old >=
Gender Male and Female
Key inclusion criteria A) The enrolled criteria is as follows.
1) The patients were diagnosed schizophrenia using the Structured Clinical interview for the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5), and had recovered from their illness.

2) The patients were diagnosed Schizophrenia using the Structured Clinical interview for the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5), and were met criteria for refractory schizophrenia.
We defineed patients who had not responded at least two antipsychotic drugs with adequate dose or not tolerated the pharmacotherapy as refractory schizophrenia.
3) Healthy subjects

B) The subjects who can be signed informed consent are enrolled in the present study.
Key exclusion criteria The patients who have any history of neurological diseases or physical diseases.
The patients who have comorbidities with other disorders, bipolar disorder, personality disorders, or mental retardation.
The patients who have previous history of substance-related disorders, such as drug dependence or alcohol dependence.
The patients who their physicians consider not suited.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryohei Igata
Organization University of Occupational and Environmental Health
Division name Department of Psychiatry
Zip code
Address 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu, Fukuoka 8078555, JAPAN
TEL 0936031611
Email igataryouhei@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Ryohei Igata
Organization University of Occupational and Environmental Health
Division name Department of Psychiatry
Zip code
Address Yahatanishi-ku, Kitakyushu, Fukuoka 8078555, JAPAN
TEL 0936031611
Homepage URL
Email igataryouhei@gmail.com

Sponsor
Institute University of Occupational and Environmental Health
Institute
Department

Funding Source
Organization University of Occupational and Environmental Health
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
2016 Year 09 Month 08 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
Date of protocol fixation
2016 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2016 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 none

Management information
Registered date
2016 Year 09 Month 08 Day
Last modified on
2016 Year 09 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027576

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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