UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032806
Receipt number R000037423
Scientific Title The effect of compensatory cognitive training for patients with schizophrenia
Date of disclosure of the study information 2018/06/01
Last modified on 2019/04/12 16:52:32

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Basic information

Public title

The effect of compensatory cognitive training for patients with schizophrenia

Acronym

The effect of compensatory cognitive training for patients with schizophrenia

Scientific Title

The effect of compensatory cognitive training for patients with schizophrenia

Scientific Title:Acronym

The effect of compensatory cognitive training for patients with schizophrenia

Region

Japan


Condition

Condition

Schizophrenia

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effect of Cognitive Remediation Therapy (CRT) focusing on the cognitive function problem in schizophrenia.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Neuropsychological tests, clinical symptom measures, NIRS and BDNF at pre and post intervention

Key secondary outcomes

Neuropsychological tests, clinical symptom measures, NIRS and BDNF at 3 months after intervention


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

CRT, once a week for 3 months

Interventions/Control_2

Non-CRT

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

16 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patient who meets ICD-10 criteria for schizophrenia
2) Patients whose condition is relatively stable
3) Patient who gave written informed consent

Key exclusion criteria

1) dependence on alcohol
2) Patients who are at high risk of violence, suicide attempts, impulsive acts
3) Patients with head trauma, cerebrovascular disorders and neurodegenerative diseases
4) Patients under 16 years of age

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Yuko
Middle name
Last name Higuchi

Organization

University of Toyama

Division name

Department of Neuropsychiatry

Zip code

930-0152

Address

2630 Sugitani, Toyama

TEL

076-434-7323

Email

yhiguchi@med.u-toyama.ac.jp


Public contact

Name of contact person

1st name Shotaro
Middle name
Last name Nakada

Organization

University of Toyama

Division name

Department of Neuropsychiatry

Zip code

930-0152

Address

2630 Sugitani, Toyama

TEL

076-434-7323

Homepage URL


Email

noutore_toyama@yahoo.co.jp


Sponsor or person

Institute

University of Toyama

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

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

Toyama university hospital Center for Clinical Research

Address

2630 Sugitani, Toyama

Tel

076-415-8857

Email

rinri@adm.u-toyama.ac.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

富山大学附属病院(富山県)、砺波サナトリウム福井病院(富山県)


Other administrative information

Date of disclosure of the study information

2018 Year 06 Month 01 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

41

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

Completed

Date of protocol fixation

2018 Year 06 Month 01 Day

Date of IRB

2017 Year 10 Month 10 Day

Anticipated trial start date

2018 Year 06 Month 01 Day

Last follow-up date

2019 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

2018 Year 05 Month 31 Day

Last modified on

2019 Year 04 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037423


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name