UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of the neural basis of intrinsic motivation in schizophrenia using fMRI and NIRS
Title of the study (Brief title)	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	Kazuyuki Nakagome
Organization	National Center of Neurology and Psychiatry
Division name	National Institute of Mental Health
Address	4-1-1, Ogawa-Higashi, Kodaira, Tokyo
TEL	042-341-2711
Email	nakagome@ncnp.go.jp

Public contact
Name of contact person	Kazuyoshi Takeda
Organization	National Center Hospital, National Center of Neurology and Psychiatry
Division name	Department of Psychiatry
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2012 Year 12 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000011452