UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001218 |
|---|---|
| Receipt number | R000001487 |
| Scientific Title | Effectiveness of CBT Augmentation in Major depression treatment: a randomized clinical trial |
| Date of disclosure of the study information | 2008/07/01 |
| Last modified on | 2015/11/04 18:27:56 |
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Basic information
Public title
Effectiveness of CBT Augmentation in Major depression treatment: a randomized clinical trial
Acronym
Effectiveness of CBT Augmentation in Major depression study (E-CAM Study)
Scientific Title
Effectiveness of CBT Augmentation in Major depression treatment: a randomized clinical trial
Scientific Title:Acronym
Effectiveness of CBT Augmentation in Major depression study (E-CAM Study)
Region
| Japan |
Condition
Condition
Major Depressive Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and cost effectiveness of cognitive behavior therapy in addition to treatment as usual with treatment as usual alone in adult patients with moderate to severe major depression who had 8weeks or longer adequate depression treatment before the study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Hamilton Depression Rating Scale (HAMD-17) change score at 16 week from the baseline will be compared between the groups.
Key secondary outcomes
Response rate (defined as 50% reduction of baseline HAMD-17), remission rate (defined as HAMD-17=<7), subjective depression (measured with the BDI and QIDS/IDS) and quality of life (measured with EQ-5D and SF-36) at 16 week and post-intervention phase (up to 12months) will be compared between the groups. Cost effectiveness (ICER per remitted patient and ICER per QALY) will be also compared between the groups.
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 considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
16 weeks of cognitive behavior therapy in addition to treatment as usual
Interventions/Control_2
16 weeks of treatment as usual alone
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-IV Major Depressive Disorder based on SCID-P at screening.
2. Subjects with HAMD-17 score >=16 at screening.
3. Subjects who had received 8 weeks or longer usual depression treatment for current depression episode at baseline.
4. Subjects with mild to moderate treatment resistance assessed at baseline (Mausdley Staging Method>=3).
5. Aged 20 years or older, and 65 years or younger at screening.
6. 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 psychotic episode.
3.No other primary DSM-IV Axis I Disorders at screening.
4.No comorbid of antisocial personality disorder.
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 severe or unstable medical co-morbidities at screening.
10.Other relevant reason decided by the E-CAM investigators.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Ono, M.D., Ph.D. |
Organization
Keio University School of Medicine
National Center of Neurology and Psychiatry
Division name
Center for CBT and research
Zip code
Address
Shinanomachi 35, Shinjuku-ku, Tokyo Keio University School of Medicine
TEL
03-5363-3214
yutakaon@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsuo Nakagawa, M.D.,Ph.D. |
Organization
Keio University School of Medicine
Division name
Department of Psychiatry
Zip code
Address
Shinanomachi 35, Shinjuku-ku, Tokyo
TEL
03-5363-3214
Homepage URL
anakagawa@keio.jp
Sponsor or person
Institute
The E-CAM Study Group
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
慶應義塾大学病院（東京都）Keio University Hospital(Tokyo)
桜ヶ丘記念病院（東京都）Sakuragaoka Memorial Hospital(Tokyo)
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
http://bmjopen.bmj.com/content/4/10/e006359.full
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
| 2008 | Year | 07 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 27 | Day |
Date of closure to data entry
| 2015 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 02 | Month | 20 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
80 enrolled (as of August 2013)
LPO 2014.12
Management information
Registered date
| 2008 | Year | 06 | Month | 30 | Day |
Last modified on
| 2015 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001487
