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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000013623
Receipt No. 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

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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
Email 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
Email sueyosi@ncnp.go.jp

Sponsor
Institute National Center of Neurology and Psychiatry
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015905

Research Plan
Registered date File name
2017/10/05 CVLT研究計画書131205_R2 - コピー.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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