UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000018155
Receipt number R000021028
Scientific Title Clinical and Neural Changes of CBT in patients with Major Depression: a Randomized Clinical Trial with fMRI investigation
Date of disclosure of the study information 2015/07/01
Last modified on 2021/06/09 18:35:14

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Basic information

Public title

Clinical and Neural Changes of CBT in patients with Major Depression: a Randomized Clinical Trial with fMRI investigation

Acronym

IMAGING study

Scientific Title

Clinical and Neural Changes of CBT in patients with Major Depression: a Randomized Clinical Trial with fMRI investigation

Scientific Title:Acronym

IMAGING study

Region

Japan


Condition

Condition

Major Depressive Disorder

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The primary object of this study is to compare brain functional change between cognitive behavioral therapy and talking control during future thinking task in patients with major depression.
We will also evaluate clinical and neuropsychological outcomes of depression.

Basic objectives2

Others

Basic objectives -Others

brain activity

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

BOLD signal during future thinking task recorded by fMRI

Key secondary outcomes

-Depression symptoms: GRID-Hamilton Depression Rating Scale, Beck Depression Inventory, Quick Inventory of Depressive Symptomatology
-Remission: defined as HAMD-17=<7
-Response: defined as 50% reduction of baseline HAMD-17total score
-Dysfunctional attitude: Dysfunctional Attitude Scale,
-Automatic thoughts: Automatic Thoughts Questionnaire Revised,
QOL: EuroQol
-Cognitive function: Word Fluency test, Digit Symbol Substitution test


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom Other

Interventions/Control_1

Cognitive Behavioral Therapy

Interventions/Control_2

Talking Control

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

70 years-old >=

Gender

Male and Female

Key inclusion criteria

1. Subjects with DSM-IV Major Depressive Disorder based on Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorder (SCID) at screening.
2. Subjects with HAMD-17 score >=16 at screening.
3. Subjects who give full consent in the participation of the study.

Key exclusion criteria

1. No comorbid alcohol or substance use disorder in 2 years prior to the screening.
2. No history or concurrent manic or psychotic episode.
3. No other primary DSM-IV Axis I Disorders in 6 months prior to the screening.
4. No comorbid of antisocial personality disorder.
5. No serious and imminent suicidal ideation at screening.
6. Unlikely to attend more than 8 visits during the 16-week trial phase (eg, due to relocation).
7. Have previously completed an individual CBT programme.
8. No organic brain lesions or major cognitive deficits in a year prior to the screening.
9. No severe or unstable medical illness at screening.
10. Contraindication to MRI (including cardiac pacemaker, claustrophobia)

Target sample size

38


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Atsuo Nakagawa, MD, PhD

Organization

Keio University School of Medicine

Division name

Center for Clinical Research

Zip code


Address

Shinanomachi 35, Shinjuku-ku, Tokyo, Japan

TEL

03-5363-3235

Email

anakagawa@keio.jp


Public contact

Name of contact person

1st name
Middle name
Last name Atsuo Nakagawa, MD, PhD

Organization

Keio University School of Medicine

Division name

Center for Clinical Research

Zip code


Address

Shinanomachi 35, Shinjuku-ku, Tokyo, Japan

TEL

03-5363-3235

Homepage URL


Email

anakagawa@keio.jp


Sponsor or person

Institute

Keio Imaging Study Group

Institute

Department

Personal name



Funding Source

Organization

Grant-in-Aid for Scientific Research

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


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

慶應義塾大学医学部/慶應義塾大学病院(東京都)


Other administrative information

Date of disclosure of the study information

2015 Year 07 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


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

Completed

Date of protocol fixation

2015 Year 05 Month 19 Day

Date of IRB

2015 Year 06 Month 22 Day

Anticipated trial start date

2015 Year 07 Month 22 Day

Last follow-up date

2020 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 07 Month 01 Day

Last modified on

2021 Year 06 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021028


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name