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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name