UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002775 |
|---|---|
| Receipt number | 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 09:25:48 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
Sponsor or person
Institute
Teikyo University, School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.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 |
