UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040361 |
|---|---|
| Receipt number | R000046061 |
| Scientific Title | CBT Leads Effectiveness Assessed by fMRI with Rumination task in patients with Major Depression: a single-arm Clinical Trial |
| Date of disclosure of the study information | 2020/05/11 |
| Last modified on | 2023/11/13 09:07:21 |
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Basic information
Public title
CBT Leads Effectiveness Assessed by fMRI with Rumination task in patients with Major Depression: a single-arm Clinical Trial
Acronym
CLEAR Study
Scientific Title
CBT Leads Effectiveness Assessed by fMRI with Rumination task in patients with Major Depression: a single-arm 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 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
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Cognitive Behavioral Therapy
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
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
40
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
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
narikoktym@keio.jp
Sponsor or person
Institute
Keio Universiyt of medicine
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
Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
03-5363-3971
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
Open public recruiting
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
38 subjects registered (November 13th, 2023)
Management information
Registered date
| 2020 | Year | 05 | Month | 11 | Day |
Last modified on
| 2023 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046061
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| Registered date | File name |
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