UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012106 |
|---|---|
| Receipt number | R000014148 |
| Scientific Title | Feasibility study of manual based cognitive behavioral therapy for depression conducted by mental health specialists in japan |
| Date of disclosure of the study information | 2013/10/25 |
| Last modified on | 2013/10/23 10:41:10 |
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Basic information
Public title
Feasibility study of manual based cognitive behavioral therapy for depression conducted by mental health specialists in japan
Acronym
Manual based CBT by mental health specialists (CREC Study)
Scientific Title
Feasibility study of manual based cognitive behavioral therapy for depression conducted by mental health specialists in japan
Scientific Title:Acronym
Manual based CBT by mental health specialists (CREC Study)
Region
| Japan |
Condition
Condition
Major Depressive Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate feasibility, effectiveness and safety of manual based CBT for adult major depression disorder conducted by Japanese trained clinical professionals.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Hamilton Depression Rating Scale(GRID-HAMD-17) score at 16 week from the baseline will be compared.
Key secondary outcomes
Remission rate (defined as GRID-HAMD-17<7; QIDS<5), response rate (defined as 50% reduction of baseline HAMD-17 and QIDS), subjective depression (measured with the BDI and QIDS), Quality of life (measured with EQ-5D and SF-36) score at 16 week from the baseline will be compared.
Dropout rate and adverse events will also be evaluated.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
Cognitive Behavioral Therapy for depression
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Subjects with current DSM-4 Major Depressive Disorder based on SCID-P at screening
2.Subjects with HAMD-17 score>16 at screening
3.Aged 20 years or older, and 65 years or younger at screening
4.Subjects who give full consent in the participation of the study
Key exclusion criteria
1.No alcohol or substance use disorder in 6 months prior to the screening.
2.No history or concurrent manic or psychiatric episode.
3.No other primary DSM-4 Axis1 Disorders at screening.
4.No comorbid of antisocial personality.
5.No serious suicidal ideation at screening.
6.Evidence of unable to participate half or more of the intervention phase.
7.No past treatment of CBT.
8.No organic brain lesions or major cognitive deficits in a year prior to the screening.
9.No sever or unstable medical co-morbidities at screening.
10.Other relevant reason decided by the CREC investigators.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsuo Nakagawa, MD, PhD |
Organization
National Center for Neurology and Psychiatry
Division name
National Center for Cognitive Behavior Therapy and Research
Zip code
Address
4-1-1 Ogawa-higashi Kodairashi Tokyo, Japan
TEL
042-341-2711
anakagawa@ncnp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriko Tamura |
Organization
National Center for Neurology and Psychiatry
Division name
National Center for Cognitive Behavior Therapy and Research
Zip code
Address
4-1-1 Ogawa-higashi Kodairashi Tokyo, Japan
TEL
042-341-2711
Homepage URL
norikotamura@ncnp.go.jp
Sponsor or person
Institute
CREC Study Group
Institute
Department
Personal name
Funding Source
Organization
Intramural Research Grant (24-4) for Neurological and Psychiatric Disorders of NCNP
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
国立精神・神経医療研究センター病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 25 | 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
Terminated
Date of protocol fixation
| 2011 | Year | 10 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 23 | Day |
Last modified on
| 2013 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014148
