UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Neurocognitive functions, social functions and decision making in schizophrenia patients comparing with healthy subjects
Title of the study (Brief title)	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	Ryohei Igata
Organization	University of Occupational and Environmental Health
Division name	Department of Psychiatry
Address	1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu, Fukuoka 8078555, JAPAN
TEL	0936031611
Email	igataryouhei@gmail.com

Public contact
Name of contact person	Ryohei Igata
Organization	University of Occupational and Environmental Health
Division name	Department of Psychiatry
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)

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

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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