UMIN-CTR Clinical Trial

Public title

Neuropsychological Studies on Cognitive Impairment in Psychiatric Disorders

Acronym

Research on Cognitive Function in Psychiatric Disorders

Scientific Title

Neuropsychological Studies on Cognitive Impairment in Psychiatric Disorders

Scientific Title:Acronym

Research on Cognitive Function in Psychiatric Disorders

Region

Japan

Condition

Depression, anxiety, obsessive-compulsive disorder, anorexia nervosa, bulimia nervosa, autism spectrum disorder, attention-deficit/hyperactivity disorder

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

In this study, cognitive functions such as inhibitory control and mental rotation in psychiatric disorders such as depression, anxiety, obsessive-compulsive disorder, eating disorders, autism spectrum disorder, and attention-deficit/hyperactivity disorder will be evaluated from multiple perspectives. By comparing the data obtained from patients with aforementioned disorders with healthy subjects, differences specific to each disorder and the relationship between each cognitive function will be clarified. The results are expected to contribute to the understanding of the pathophysiology of mental disorders and to the improvement of treatment effects.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The overall target number of patients is 280. This includes 196 patients with psychiatric disorders (depression, anxiety, obsessive-compulsive disorder, anorexia nervosa, bulimia nervosa, autism spectrum disorder, and attention-deficit/hyperactivity disorder) and 28 patients in the subthreshold anxiety group. In addition, the number of healthy subjects will be 56. Because of the wide range of cognitive impairments in each disease, the effect size was set to be small (0.2) and the dropout rate was expected to be 10%, resulting in 28 subjects in each group. The number of healthy participants was set at 56, in order to match the age and gender of the participants with each disease, and to provide a comparison group. Over a two-year period, it is expected to obtain data from half of the participants.

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

Cognitive Tasks
1) Stop-Signal Task
2) Comprehensive Ability Battery-Spatial (CAB-S)
3) Vandenberg & Kuse Mental Rotation Test

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

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Selection Criteria for Patient Groups
1) Patients will be selected by using the Mini-International Neuropsychiatric Interview (M.I.N.I.), and the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-R or DSM-5).
2) The patient has residual symptoms of moderate severity or greater.
3) Symptoms in 1) are the main obstacle in the patient's life and other comorbidities are acceptable as long as they are secondary.
4) Patients must be at least 18 years of age.
5) Patients who have been fully informed of the study and have given their free and voluntary written consent based on a full understanding of the study.
Rationale:
1-2) To identify the target disease.
3) To reflect the clinical picture by recognizing comorbidities as much as possible.
4-5) To consider safety and ethical aspects.
Selection criteria for the subthreshold anxiety group
1) Patients with no history of psychiatric disorders and no current symptoms
2) Patients who do not meet the criteria for a psychotic episode on the M.I.N.I.
3) LSAS score of 50 or higher
4) Age 18 years or older.
5) The patient must have been fully informed of the study and must have given his/her free and voluntary written consent based on a thorough understanding of the study.
Rationale:
1-3)To identify the subjects.
To reflect the clinical picture by recognizing comorbidities as much as possible.
4-5) To consider safety and ethical aspects.
Selection Criteria for Healthy Subjects
1) No history of psychiatric disorders and no current symptoms
2) Age 18 years or older.
3) Participants who have been fully informed of the study and who have given written consent of their own free will based on a thorough understanding of the study.
Rationale:
1) To identify the target population.
To recognize comorbidities as much as possible to better reflect the clinical picture.
2-3) To consider safety and ethical aspects.

Key exclusion criteria

1) Those at imminent risk of suicide
2) Those with antisocial personality disorder
3) Patients with serious mental disorders that may require hospitalization.
4) Patients who cannot give their free and voluntary written consent after receiving a full explanation of their participation in this study and with full understanding.
5) Other subjects deemed inappropriate by the PI.
[Rationale]
1-5) For ethical and safety considerations.

Target sample size

280

Name of lead principal investigator

1st name	Yoshiyuki
Middle name
Last name	Hirano

Organization

Chiba University

Division name

Research Center for Child Mental Development

Zip code

260-8670

Address

1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba-ken, Japan

TEL

043-226-2975

Email

hirano@chiba-u.jp

Name of contact person

1st name	Sertap
Middle name
Last name	Maral

Organization

Chiba University

Division name

Research Center for Child Mental Development

Zip code

260-8670

Address

1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba-ken, Japan

TEL

043-226-2975

Homepage URL

Email

22fm0125@student.gs.chiba-u.jp

Institute

Chiba University

Institute

Department

Personal name

Organization

Ministry of Education, Culture, Sports, Science and Technology (MEXT)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Chiba University Hospital Clinical Research Ethics Review Committee

Address

1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba-ken

Tel

043-222-7171

Email

igaku-rinri@office.chiba-u.jp

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

2023

Year

06

Month

29

Day

URL releasing protocol

Publication of results

Unpublished

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

Open public recruiting

Date of protocol fixation

2023

Year

02

Month

27

Day

Date of IRB

2023

Year

06

Month

28

Day

Anticipated trial start date

2023

Year

06

Month

28

Day

Last follow-up date

2025

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

06

Month

28

Day

Last modified on

2023

Year

06

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058494