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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000037191
Receipt No. R000042398
Scientific Title Rumination Focused Cognitive-Behavioral Therapy for Treatment-resistant Depression: A Pilot study
Date of disclosure of the study information 2019/06/27
Last modified on 2019/12/27

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Basic information
Public title Rumination Focused Cognitive-Behavioral Therapy for Treatment-resistant Depression: A Pilot study
Acronym RFCBT-Pilot study
Scientific Title Rumination Focused Cognitive-Behavioral Therapy for Treatment-resistant Depression: A Pilot study
Scientific Title:Acronym Rumination Focused Cognitive-Behavioral Therapy for Treatment-resistant Depression: A Pilot study
Region
Japan

Condition
Condition Treatment-resistant Depression
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate safety, efficacy and feasibility of Rumination Focused Cognitive-Behavioral Therapy for Treatment-resistant Depression
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes 1. Baseline reduction score of GRID-Hamilton Depression Rating Scale (GRID-HAMD) at 16wk
2. Drop-out rate
Key secondary outcomes 1. Baseline reduction score of GRID-Hamilton Depression Rating Scale (GRID-HAMD) at 28 and 40wk
2. Beck Depression Inventory (BDI-II), Generalized Anxiety Disorder (GAD-7), Ruminative Responses Scale (RRS), Sheehan Disability Scale (SDISS), Cognitive-Behavioral Avoidance Scale (CBAS), Coping Inventory for Stressful Situations (CISS): 0,8,16,28,40 wks
3. Quick Inventory of Depressive Symptomatology (QIDS), Euro-Qol (EQ-5D), Session Rating Scale (SRS) at each session
4. Client satisfaction questionnaire (CSQ-8j): 0, 8,16 wks

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
Interventions/Control_1 Rumination Focused Cognitive-Behavioral Therapy
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
70 years-old >=
Gender Male and Female
Key inclusion criteria 1) having a diagnosis of DSM-IV Major Depressive Disorder confirmed with the SCID
2) have been treated with antidepressants or cognitive behavioral therapy for depression at least 8 weeks up to screening.
3) GRID-HAMD-17>=14
4) can attend session more than 8
5) 20 years old <= age <70 years old
6) can obtain written consent
Key exclusion criteria 1) No alcohol or substance use disorder in 12 months prior to the screening
2) No history or concurrent manic episode or psychotic disorders
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) No organic brain lesions or major cognitive deficits in a year prior to the screening
7) No severe or unstable medical co-morbidities at screening
8) No structured psychotherapy during the intervention.
9) Other relevant reason decided by the CBT principal investigator.
Target sample size 8

Research contact person
Name of lead principal investigator
1st name Atsuo
Middle name
Last name Nakagawa, MD, PhD
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry
Zip code 160-8582
Address Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL 03-5363-3235
Email anakagawa@keio.jp

Public contact
Name of contact person
1st name Atsuo
Middle name
Last name Nakagawa, MD, PhD
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry
Zip code 160-8582
Address Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL 03-5363-3235
Homepage URL
Email anakagawa@keio.jp

Sponsor
Institute Keio University School of Medicine, Department of Neuropsychiatry
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Keio University School of Medicine
Address Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
Tel 03-3353-1211
Email med-rinri-jimu@adst.keio.ac.jp

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 慶應義塾大学医学部・慶應義塾大学病院 (東京都)
Keio University School of Medicine, Department of Neuropsychiatry (Tokyo)

Other administrative information
Date of disclosure of the study information
2019 Year 06 Month 27 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 Enrolling by invitation
Date of protocol fixation
2019 Year 05 Month 21 Day
Date of IRB
2019 Year 06 Month 24 Day
Anticipated trial start date
2019 Year 07 Month 04 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 06 Month 27 Day
Last modified on
2019 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042398

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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