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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002775
Receipt No. R000003376
Scientific Title The development of computer software (CogPack) to improve cognitive dysfunction and the efficacy of cognitive rehabilitation by using CogPack for the patient with mental disorders
Date of disclosure of the study information 2009/11/17
Last modified on 2012/05/17

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Basic information
Public title The development of computer software (CogPack) to improve cognitive dysfunction and the efficacy of cognitive rehabilitation by using CogPack for the patient with mental disorders
Acronym The efficacy of cognitive rehabilitation for the patient with mental disorders
Scientific Title The development of computer software (CogPack) to improve cognitive dysfunction and the efficacy of cognitive rehabilitation by using CogPack for the patient with mental disorders
Scientific Title:Acronym The efficacy of cognitive rehabilitation for the patient with mental disorders
Region
Japan

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

Objectives
Narrative objectives1 The purpose of this trial is to look into the efficacy of cognitive rehabilitation for cognitive functions in schizophrenia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cognitive function (Brief Assessment of Cognition in Schizophrenia: BACS)
Key secondary outcomes 1.Social function (Life Assessment Scale for Mentally Ill: LASMI)
2.Psychotic symptoms (Positive and Negative Syndrome Scale: PANSS)
3.Work Sample Makuhari version

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Cognitive rehabilitation (twice a week, 45-60min/session, 24sessions)
Interventions/Control_2 Treatment as usual
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 1) Schizophrenia or Schizoaffective disorders (diagnosed by ICD-10 DCR)
2) Age; 20-60 y.o.
Key exclusion criteria 1) Patients with mental retardation
2) Patients who have history of organic brain disorders
3) Patients with dementia, alcohol dependence or psychoactive substance dependence
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Emi Ikebuchi
Organization Teikyo University, School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address 2-11-1 Kaga, Itabashi-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Teikyo University, School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address 2-11-1 Kaga, Itabashi-ku, Tokyo
TEL
Homepage URL
Email

Sponsor
Institute Teikyo University, School of Medicine
Institute
Department

Funding Source
Organization The Ministry of Health, Welfare and Labor of the Japanese Government
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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・神経センター病院(東京都)
大阪府立精神医療センター(大阪府)
三家クリニック(大阪府)
埼玉精神神経センター(埼玉県)
福島県立会津総合病院(福島県)
南浜病院(新潟県)

Other administrative information
Date of disclosure of the study information
2009 Year 11 Month 17 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 No longer recruiting
Date of protocol fixation
2009 Year 07 Month 31 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 11 Month 17 Day
Last modified on
2012 Year 05 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003376

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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