Unique ID issued by UMIN | UMIN000040361 |
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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 |
CBT Leads Effectiveness Assessed by fMRI with Rumination task in patients with Major Depression: a single-arm Clinical Trial
CLEAR Study
CBT Leads Effectiveness Assessed by fMRI with Rumination task in patients with Major Depression: a single-arm Clinical Trial
CLEAR Study
Japan |
Major Depressive Disorder
Psychiatry |
Others
NO
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.
Others
Brain activity
Exploratory
Pragmatic
Phase II
Bold signal during rumination task recorded by fMRI
-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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
1
Treatment
Behavior,custom | Other |
Cognitive Behavioral Therapy
20 | years-old | <= |
60 | years-old | >= |
Male and Female
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.
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)
40
1st name | Atsuo |
Middle name | |
Last name | Nakagawa |
Keio University School of Medicine
Keio University Hospital Clinical and Translational Research Center
160-8582
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
03-5363-32350
anakagawa@keio.jp
1st name | Nariko |
Middle name | |
Last name | Katayama |
Keio University School of Medicine
Department of Neuropsychiatry
160-8582
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
03-5363-3971
narikoktym@keio.jp
Keio Universiyt of medicine
Grant-in-Aid for Scientific Research
Japanese Governmental office
Japan
Keio University School of Medicine
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
03-5363-3971
narikoktym@keio.jp
NO
慶應義塾大学医学部/慶應義塾大学病院(東京都)
2020 | Year | 05 | Month | 11 | Day |
Unpublished
Open public recruiting
2020 | Year | 02 | Month | 05 | Day |
2020 | Year | 03 | Month | 25 | Day |
2020 | Year | 05 | Month | 18 | Day |
2025 | Year | 03 | Month | 31 | Day |
38 subjects registered (November 13th, 2023)
2020 | Year | 05 | Month | 11 | Day |
2023 | Year | 11 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046061
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