UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023977 |
|---|---|
| Receipt number | 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 09:02:03 |
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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
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
igataryouhei@gmail.com
Sponsor or person
Institute
University of Occupational and Environmental Health
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027576
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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