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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040361
Receipt No. R000046061
Scientific Title CBT Leads Effectiveness Assessed by fMRI with Rumination task in patients with Major Depression: a Randomized Clinical Trial
Date of disclosure of the study information 2020/05/11
Last modified on 2020/07/14

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Basic information
Public title CBT Leads Effectiveness Assessed by fMRI with Rumination task in patients with Major Depression: a Randomized Clinical Trial
Acronym CLEAR Study
Scientific Title CBT Leads Effectiveness Assessed by fMRI with Rumination task in patients with Major Depression: a Randomized Clinical Trial
Scientific Title:Acronym CLEAR 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 rumination 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 rumination 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
-Anxiety symptoms: Generalized Anxiety Disorder -7
- Hopelessness: Beck Hopelessness Scale
-Rumination : Ruminative Response Scale
-Aboidance: Cognitive-Behavioral Avoidance Scale
-Coping: Coping Inventory for Stressful Situations
-Disability: Sheehan Disability Scale
-QOL: EuroQol
-resting state functional connectivity (resting-fMRI)
-Cognition on future-thinking: future-thinking task
-Cognitive function: CABTAB or The Brief Assessment of Cognition in Schizophrenia: BACS-J

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
60 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 >=14 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 program.
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 60

Research contact person
Name of lead principal investigator
1st name Atsuo
Middle name
Last name Nakagawa
Organization Keio University School of Medicine
Division name Keio University Hospital Clinical and Translational Research Center
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 03-5363-32350
Email anakagawa@keio.jp

Public contact
Name of contact person
1st name Nariko
Middle name
Last name Katayama
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 03-5363-3971
Homepage URL
Email narikoktym@keio.jp

Sponsor
Institute Keio Universiyt of medicine
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 Keio University School of Medicine
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel 03-5363-3971
Email narikoktym@keio.jp

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
2020 Year 05 Month 11 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 Preinitiation
Date of protocol fixation
2020 Year 02 Month 05 Day
Date of IRB
2020 Year 03 Month 25 Day
Anticipated trial start date
2020 Year 05 Month 18 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
Other related information

Management information
Registered date
2020 Year 05 Month 11 Day
Last modified on
2020 Year 07 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046061

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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