UMIN-ICDS Clinical Trial

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
Institute	Keio Imaging Study Group
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021028