UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000025220
Receipt No. R000028926
Scientific Title A randomized controlled trial of cognitive behavior therapy as an adjunct to usualcare for panic disorder refractory to medical treatment
Date of disclosure of the study information 2016/12/11
Last modified on 2017/12/11

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A randomized controlled trial of cognitive behavior therapy as an adjunct to usualcare for panic disorder refractory to medical treatment
Acronym RCT about the effectiveness of the CBT for medical treatment-resistant panic disorder patients
Scientific Title A randomized controlled trial of cognitive behavior therapy as an adjunct to usualcare for panic disorder refractory to medical treatment
Scientific Title:Acronym RCT about the effectiveness of the CBT for medical treatment-resistant panic disorder patients
Region
Japan

Condition
Condition panic disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effectiveness of cognitive behavioral therapy as an adjunct to usual care when compared to usual care alone in patients with panic disorder refractory to medical treatment.
Basic objectives2 Others
Basic objectives -Others To examine clinical and cost effectiveness of cognitive behavioral therapy as an adjunct to usual care 16weeks after.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Panic Disorder Severity Scale(PDSS)(assessor-rated)
Key secondary outcomes PAS(Panic and Agoraphobia Scale)
PHQ-9(Patient Health Questionnare-9)
GHQ-7(Generalized anxiety disorder-7)
EQ-5D-5L(EuroQol5-Dimension-5Levels)
MDS(Mental Defeat Scale)
CFS(Cognitive Flexibility Scale)

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 Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 cognitive behavioral therapy(16 weeks)
Interventions/Control_2 usual care only(16 weeks)
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
18 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria Primary diagnosis of Panic Disorder refractory to medicine(Taking antidepressant or anti-anxiety drugs treatment and had done so for at least 8 weeks at an adequate dose while remaining at least moderately ill(PDSS >=8)).
Key exclusion criteria psychosis, major depression, bipolar, active suicidality, organic brain disorder, substance abuse or dependence, antisocial personality disorder, other severe mental / physical condition
Target sample size 44

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eiji Shimizu
Organization Graduate School of Medicine Chiba University,Chiba University Hospital
Division name Research Center for Child Mental Development, Department of Cognitive Behavioral Physiology,Cognitive Behavioral Therapy Center
Zip code
Address 1-8-1 Inohana, Chuouku, Chiba, Japan
TEL 043-226-2027
Email eiji@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoichi Seki
Organization Chiba University Hospital
Division name Cognitive Behavioral Therapy Center
Zip code
Address 1-8-1 Inohana, Chuouku, Chiba, Japan
TEL 043-222-7171
Homepage URL
Email yoichi-seki@chiba-u.jp

Sponsor
Institute Chiba University Hospital
Institute
Department

Funding Source
Organization Ministry of education
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
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

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 11 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
2016 Year 11 Month 21 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 08 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
2016 Year 12 Month 11 Day
Last modified on
2017 Year 12 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028926

Research Plan
Registered date File name
2017/06/19 資料6)様式17臨床試験実施計画書パニックRCT(1.2版).docx

Research case data specifications
Registered date File name
2017/06/19 パニック_CRF2_治療開始1・8・16週_ver1.0.docx

Research case data
Registered date File name


Contact us.