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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000009781
Receipt No. R000011452
Scientific Title Investigation of the neural basis of intrinsic motivation in schizophrenia using fMRI and NIRS
Date of disclosure of the study information 2013/01/21
Last modified on 2018/07/22

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Basic information
Public title Investigation of the neural basis of intrinsic motivation in schizophrenia using fMRI and NIRS
Acronym Neural basis of intrinsic motivation in schizophrenia
Scientific Title Investigation of the neural basis of intrinsic motivation in schizophrenia using fMRI and NIRS
Scientific Title:Acronym Neural basis of intrinsic motivation in schizophrenia
Region
Japan

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

Objectives
Narrative objectives1 To explore the neural basis of intrinsic motivation in schizophrenia and to establish a relevant biological marker
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Brain activation data using fMRI and NIRS along with behavioral data obtained while patients are processing Stop watch/Watch stop (SW/WS) task, which was designed to invoke intrinsic motivation in patients with schizophrenia.
JART-25
PANSS
UPSA-B
SLOF
GAF
IMI
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
50 years-old >=
Gender Male and Female
Key inclusion criteria (1)Fifteen patients with schizophrenia according to the DSM-IV criteria recruited from outpatients and inpatients of National Center Hospital, National Center of Neurology and Psychiatry (NCNP). All patients were 20-50 years old and had the capacity to give written informed consent.

(2)Fifteen healthy controls aged 20-50 years old without any history of psychiatric and neurological illness, who consented to participate in the study
Key exclusion criteria (1)Patients with the estimated IQ lower than 80 (by Japanese Adult Reading Test)
(2)Patients with history of organic brain disorder, dementia, pervasive developmental disorder, or substance/alcohol dependence.
(3)Patients with severe irritation that hindered them from being seated still during the experiment.
(4)Patients for whom changes in medication were presumed to be necessary during the study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuyuki Nakagome
Organization National Center of Neurology and Psychiatry
Division name National Institute of Mental Health
Zip code
Address 4-1-1, Ogawa-Higashi, Kodaira, Tokyo
TEL 042-341-2711
Email nakagome@ncnp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuyoshi Takeda
Organization National Center Hospital, National Center of Neurology and Psychiatry
Division name Department of Psychiatry
Zip code
Address 4-1-1, Ogawa-Higashi, Kodaira, Tokyo
TEL 042-341-2711
Homepage URL
Email ktakeda@ncnp.go.jp

Sponsor
Institute National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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 国立精神・神経医療研究センター病院(東京都)

Other administrative information
Date of disclosure of the study information
2013 Year 01 Month 21 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Main results already published
Date of protocol fixation
2012 Year 12 Month 15 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 01 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Brain activation as well as behavioral data would be compared between patients with schizophrenia and normal controls. In addition, relationship between brain activation and neuropsychological indices would be examined in schizophrenia.

Management information
Registered date
2013 Year 01 Month 14 Day
Last modified on
2018 Year 07 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011452

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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