UMIN-CTR Clinical Trial

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

Bipolar disorder

Classification by specialty

Psychiatry

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

National Center of Neurology and Psychiatry

Institute

Department

Personal name

Organization

MHLW

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Hokkaido University
Nagoya University
Fujita Health University

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2014

Year

05

Month

03

Day

URL releasing protocol

Publication of results

Published

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

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 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.

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