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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002542
Receipt No. R000003108
Scientific Title Effectiveness Study of Cognitive Behavioral Therapy for Depression - an open-label pilot study
Date of disclosure of the study information 2009/09/24
Last modified on 2010/07/30

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Basic information
Public title Effectiveness Study of Cognitive Behavioral Therapy for Depression - an open-label pilot study
Acronym Cognitive Behavioral Therapy for Depression - an open-label pilot study
Scientific Title Effectiveness Study of Cognitive Behavioral Therapy for Depression - an open-label pilot study
Scientific Title:Acronym Cognitive Behavioral Therapy for Depression - an open-label pilot study
Region
Japan

Condition
Condition Major Depressive Disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To test effectiveness and feasibility of cognitive behavioral therapy for depression in Japanese clinical settings
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Beck Depression Inventory-II
Key secondary outcomes Hamilton Depression Rating Scale(HAMD)
Quick Inventory of Depressive Symptomatology-self rated (QIDS-SR)
WHO Subjective Wellbeing Inventory(SUBI)
Clinical Global Imression - severity (CGI-S)
Dysfunctional Attitude Scale (DAS24)
Global Assessment of Functioning (GAF) on DSM-IV

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
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 Primary diagnosis of Major Depressive Disorder
Key exclusion criteria active suicidality
organic brain disorder
antisocial personality disorder
other severe mental / physical condition
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daisuke Fujisawa
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address 35 Shinanomachi, Shinjuku, Tokyo, Japan
TEL 03-3353-1211
Email

Public contact
Name of contact person
1st name
Middle name
Last name Daisuke Fujisawa
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address 35 Shinanomachi, Shinjuku, Tokyo, Japan
TEL 03-3353-1211
Homepage URL
Email dai_fujisawa@yahoo.co.jp

Sponsor
Institute Keio University Cognitive Therapy Study Group
Institute
Department

Funding Source
Organization Japan Ministry of Health and Labor
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 桜ケ丘記念病院(東京都)、慈雲堂内科病院(東京都)、東京女子医大附属病院(東京都)、東邦大学病院(東京都)、昭和大学病院(東京都)
Sakuragaoka Memorial Hospital (Tokyo), Jiundo Naika Hospital (Tokyo), Tokyo Women's University Hospital (Tokyo), Toho University Hospital (Tokyo), Showa University Hospital (Tokyo)

Other administrative information
Date of disclosure of the study information
2009 Year 09 Month 24 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
A total of 27 patients with major depression were enrolled and 26 (96%) completed the study. The mean total score of Beck Depression Inventory-II (BDI-II) for all patients (Intention-to-treat sample:ITT) improved from 32.6 to 11.7 during the program with the mean change of 20.8 (95% confidence interval: 17.0 to 24.8). Within-group effect size at endpoint assessment was 2.64 (Cohen's d) on the BDI-II. For the ITT sample, 21 (77.7%) patients showed treatment response and 17 patients (63.0%) achieved remission and at the end of the program. Significant improvement in measurement of objective depression severity, global improvement, dysfunctional attitude, global functioning and subjective well-being were also observed (all p values<0.001). 
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
2004 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2004 Year 04 Month 01 Day
Last follow-up date
2007 Year 08 Month 01 Day
Date of closure to data entry
2007 Year 09 Month 01 Day
Date trial data considered complete
2008 Year 03 Month 01 Day
Date analysis concluded
2008 Year 03 Month 01 Day

Other
Other related information Fujisawa D, Nakagawa A, Tajima M, Sado M, Kikuchi T, Hanaoka M, Ono Y.
Cognitive behavioral therapy for depression among adults in Japanese clinical settings: a single-group study.
BMC Res Notes. 2010 Jun 7;3:160.
PMID: 20529252

Management information
Registered date
2009 Year 09 Month 24 Day
Last modified on
2010 Year 07 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003108

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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