UMIN-CTR Clinical Trial

Basic information
Public title	Explorative study on the effect of novel training program on visual perceptual dysfunction of schizophrenia
Acronym	Explorative study on the effect of novel training program on visual perceptual dysfunction of schizophrenia
Scientific Title	Explorative study on the effect of novel training program on visual perceptual dysfunction of schizophrenia
Scientific Title:Acronym	Explorative study on the effect of novel training program on visual perceptual dysfunction of schizophrenia
Region	Japan

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

Objectives
Narrative objectives1	In this study, we develop software applying Backward Masking task, which is a neuropsychological task of visual perception.
Basic objectives2	Others
Basic objectives -Others	And we will examine the feasibility, safety and tolerability as a training program aimed at enhancing neurocognition of schizophrenia.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	cognitive function: BACS, BVMT-R, FEST (baseline, pre-training, post-training, follow up)
Key secondary outcomes	psychiatric symptoms: PANSS (baseline, pre-training, post-training, follow up)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Training was conducted over 6 weeks and included 20 sessions of 3 different VBM tasks. Two training tasks involved letter identification; one with a mask of overlapping X's that spatially coincided with the target (T1) and one with a non-overlapping mask (T2). The third task (T3) presented a circle in one of four locations followed by a mask with 3 X's in all four locations, and required the user to determine the target circle's location.
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	60 years-old >=
Gender	Male and Female
Key inclusion criteria	Participants were people with schizophrenia or schizoaffective disorder, and the medication was not changed from 6 months prior the baseline assessment.
Key exclusion criteria	Exclusion criteria were premorbid IQ lower than 70, substance abuse in the last 6 months, history of neurological illness or injury, corrected visual acuity worse than 20/30, clinically unstable .
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Satoru Middle name Last name Ikezawa
Organization	National Center of Neurology and Psychiatry
Division name	National Center Hospital
Zip code	187-8551
Address	4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8551, JAPAN
TEL	042-341-2711
Email	satoru.ikezawa@ncnp.go.jp

Public contact
Name of contact person	1st name Satoru Middle name Last name Ikezawa
Organization	National Center of Neurology and Psychiatry
Division name	National Center Hospital
Zip code	187-8551
Address	4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8551, JAPAN
TEL	042-341-2711
Homepage URL
Email	satoru.ikezawa@ncnp.go.jp

Sponsor
Institute	National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization	The Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Center of Neurology and Psychiatry
Address	4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8551, JAPAN
Tel	042-341-2711
Email	rinri-jimu@ncnp.go.jp

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	2019 Year 07 Month 12 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	8
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	No longer recruiting
Date of protocol fixation	2016 Year 02 Month 09 Day
Date of IRB	2016 Year 04 Month 01 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 07 Month 12 Day
Last modified on	2019 Year 07 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042580