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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001218
Receipt No. 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

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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
Email 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
Email anakagawa@keio.jp

Sponsor
Institute The E-CAM Study Group
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001487

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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