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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030708
Receipt No. R000035060
Scientific Title Japan Unified Protocol Clinical Trial for Depressive and Anxiety Disorders
Date of disclosure of the study information 2018/01/06
Last modified on 2019/07/09

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Basic information
Public title Japan Unified Protocol Clinical Trial for Depressive and Anxiety Disorders
Acronym JUNP Study
Scientific Title Japan Unified Protocol Clinical Trial for Depressive and Anxiety Disorders
Scientific Title:Acronym JUNP Study
Region
Japan

Condition
Condition Anxiety Disorders
Depressive Disorders
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study is to examine the superiority of the combined treatments of transdiagnostic cognitive-behavior therapy (Unified Protocol; UP) and Treatment-As-Usual in comparison with the waiting-list with Treatment-As-Usual in the reduction of depressive and anxiety symptoms among depressive and anxiety disorders.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase III

Assessment
Primary outcomes GRID-Hamilton Depression Rating Scale-17 (GRID-HAMD) [ Time Frame: 21 weeks ]
Key secondary outcomes Hamilton Anxiety Rating Scale 14 item(HAM-A) [ Time Frame: 21 weeks ]
Clinical Global Impression- Severity(CGI-S) [ Time Frame: 21 weeks ]
Clinical Global Impression-Improvement(CGI-I) [ Time Frame: 21 weeks ]
Responder Status assessed by GRID-HAMD [ Time Frame: 21 weeks ](Reduction in GRID-HAMD score of at least 50% compared with baseline)
Remission of symptoms assessed by GRID-HAMD [ Time Frame: 21 weeks ](GRID-HAMD score of less than 8)
Psychiatric diagnosis assessed by Structured Clinical Interview for the DSM(SCID) [ Time Frame: 21 weeks ]

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom Other
Interventions/Control_1 Experimental: Unified Protocol with Treatment As Usual
Unified Protocol is designed to help patients learn how to confront and experience uncomfortable emotions and learn how to respond to their emotions in more adaptive ways. Individual treatment sessions will be conducted by experienced clinicians who will be trained in the administration of this protocol. A workbook will be provided to each patient as part of this manualized treatment. During this treatment period, the participants continue the Treatment As Usual.
Interventions/Control_2 Waitlist Control with Treatment As Usual
Waitlist participants will not receive treatment during a 20-week waitlist period, but will receive the unified protocol immediately following the 20 week waiting period. During the waitlist period, the waitlist participants continue the treatment as usual.
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 (a) DSM-IV diagnosis of Major Depressive Disorder, Dysthymia, Depressive Disorder Not Otherwise Specified, Panic Disorder With Agoraphobia, Panic Disorder Without Agoraphobia, Agoraphobia Without History of Panic Disorder, Social Phobia(Social Anxiety Disorder), Obsessive-Compulsive Disorder, Posttraumatic Stress Disorder, Generalized Anxiety Disorder, Anxiety Disorder Not Otherwise Specified assessed by SCID.
(b) Depressive and anxiety symptoms is mild or more severe (GRID-HAMD >= 8).
(c) Ages 20 years or older, and 65 years or younger at screening.
(d) Subjects who give full consent in the participation of the study.
Key exclusion criteria (a) No alcohol or substance use disorder in 6 months prior to the screening assessed by SCID
(b) No current manic episode or current schizophrenia and other psychotic disorders at baseline assessed by SCID
(c) No serious suicidal ideation at baseline (GRID-HAMD Item3 severity is 3 or higher.)
(d) No life-threatening, severe or unstable physical disorders or major cognitive deficits at baseline.
(e) Evidence of unable to participate half or more of the intervention phase.
(f) No structured psychotherapy during at baseline.
(g) Other relevant reason decided by the investigators.
Target sample size 104

Research contact person
Name of lead principal investigator
1st name Masaya
Middle name
Last name Ito
Organization National Center of Neurology and Psychiatry
Division name National Center of Cognitive-Behavior Therapy and Research
Zip code 187-8551
Address Kodaira, Tokyo, Japan, 187-8551
TEL +81-42-341-2712(3605)
Email masaya-ito@umin.ac.jp

Public contact
Name of contact person
1st name Masaya
Middle name
Last name Ito
Organization National Center of Neurology and Psychiatry
Division name National Center of Cognitive-Behavior Therapy and Research
Zip code 187-8551
Address Kodaira, Tokyo, Japan, 187-8551
TEL +81-42-341-2712(3605)
Homepage URL http://cbt.ncnp.go.jp/research/archives/5
Email masaya-ito@umin.ac.jp

Sponsor
Institute National Center of Neurology and Psychiatry, Japan
Institute
Department

Funding Source
Organization KAKENHI Grant-in-aid for young scientists(A)
National Center of Neurology and Psychiatry (NCNP) Intramural Research Grant
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Institutional Review Board at National Center of Neurology and Psychiatry
Address Kodaira, Tokyo, Japan, 187-8551
Tel +81-42-341-2711
Email rinri-jimu@ncnp.go.jp

Secondary IDs
Secondary IDs YES
Study ID_1 NCT02003261
Org. issuing International ID_1 U.S. National Library of Medicine
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

Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 06 Day

Related information
URL releasing protocol https://bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-016-0779-8
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 104
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
2013 Year 10 Month 02 Day
Date of IRB
2013 Year 10 Month 30 Day
Anticipated trial start date
2013 Year 12 Month 06 Day
Last follow-up date
2019 Year 04 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 01 Month 06 Day
Last modified on
2019 Year 07 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035060

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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