UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037344
Receipt number R000042580
Scientific Title Explorative study on the effect of novel training program on visual perceptual dysfunction of schizophrenia
Date of disclosure of the study information 2019/07/12
Last modified on 2019/07/12 14:59:57

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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 or person

Institute

National Center of Neurology and Psychiatry

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042580


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name