UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013623 |
|---|---|
| Receipt number | R000015905 |
| Scientific Title | Study on the validation of the California Verbal Learning Test- 2nd Edition- Japanese version |
| Date of disclosure of the study information | 2014/05/03 |
| Last modified on | 2017/10/05 09:20:20 |
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Basic information
Public title
Study on the validation of the California Verbal Learning Test- 2nd Edition- Japanese version
Acronym
Validity of the California Verbal Learning Test- 2nd Edition- Japanese version
Scientific Title
Study on the validation of the California Verbal Learning Test- 2nd Edition- Japanese version
Scientific Title:Acronym
Validity of the California Verbal Learning Test- 2nd Edition- Japanese version
Region
| Japan |
Condition
Condition
Bipolar disorder
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the utility and validity of the CVLT-II Japanese version in the assessment of verbal memory deficits in patients with bipolar disorder
Basic objectives2
Others
Basic objectives -Others
To investigate the validity of cognitive function measures
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
CVLT-II
BACS-J(Brief Assessment of Cognitive function in Schizophrenia Japanese version
UPSA-B (International version)
SLOF(Specific Levels of Functioning Assessment)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
A. Patients
(1) Meeting DSM-V criteria for bipolar disorder (type I or II)
(2) Outpatients
(3)20 or older and younger than 60 in age
(4)remitted at the time of assessment, i.e. 7 points or less with the Montgomery-Asberg Depression Rating Scale, and 8 points or less with the Young Mania Rating Scale
(5) Having a family member or caregiver capable of assessing social/functional outcome of the subject
(6) Capable of understanding the purpose and content of the study, and providing informed consent to participate
B. Healthy subjects
(1) Not meeting any of the DSM-V criteria
(2) 20 or older and younger than 60 in age
(3)Capable of understanding the purpose and content of the study, and providing informed consent to participate
Key exclusion criteria
A. Patients
(1) Past or present history of severe organic brain lesions or injury (with conciousness loss lasting 10 minutes or longer)
(2) Comorbidity of alcohol or substance use (excluding caffeine and nicotine) witnin 12 months
(3)Meeting DSM-V criteria for personality disorder or mental retardation
(4) Not eligible due to other reasons as judged by investigators
B. Healthy subjects
Same as in patients
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomiki Sumiyoshi |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Clinical Epidemiology
Zip code
Address
4-1-1 Ogawahigashi-cho, Kodaira, Tokyo
TEL
042-341-2711
sumiyot@ncnp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuki Sueyoshi |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Clinical Epidemiology
Zip code
Address
4-1-1 Ogawahigashi-cho, Kodaira, Tokyo
TEL
042-341-2711
Homepage URL
sueyosi@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
MHLW
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Hokkaido University
Nagoya University
Fujita Health University
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
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
Main results already published
Date of protocol fixation
| 2014 | Year | 01 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 07 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 09 | Month | 01 | Day |
Other
Other related information
The principal aim is to see if scores of the CVLT-II will be correlated with those of BACS-J, HVLT, and UPSA-B. The difference in performance on the CVLT-II between patients and control subjects will also be evaluated.
Management information
Registered date
| 2014 | Year | 04 | Month | 03 | Day |
Last modified on
| 2017 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015905
