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 UMIN000003331
Receipt No. R000004021
Scientific Title Biological predictors of responsiveness to cognitive behaviour therapy for anxiety disorders, depression and bulimia nervosa: a randomised controlled trial.
Date of disclosure of the study information 2010/04/01
Last modified on 2015/06/24

* 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 Biological predictors of responsiveness to cognitive behaviour therapy for anxiety disorders, depression and bulimia nervosa: a randomised controlled trial.
Acronym A randomised controlled trial of cognitive behaviour therapy and biological predictors.
Scientific Title Biological predictors of responsiveness to cognitive behaviour therapy for anxiety disorders, depression and bulimia nervosa: a randomised controlled trial.
Scientific Title:Acronym A randomised controlled trial of cognitive behaviour therapy and biological predictors.
Region
Japan

Condition
Condition anxiety disorders, obsessive compulsive disorders, eating disorders, depression and related disorders
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to compare the efficacy and cost-effectiveness of cognitive behaviour therapy (CBT) and treatment as usual (TAU) in patients with anxiety disorders, obsessive compulsive disorders, bulimia nervosa, depressive disorders and related disorders.
Basic objectives2 Others
Basic objectives -Others The aim of this study was to investigate biomarkers of predictors for the responders to CBT.
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Body mass index(BMI), frequency of binge-eating and purging behaviours,BITE,EDEQ,HADS,YBOCS
Key secondary outcomes Wisconsin Card Sorting Test (WCST), Trail Making Test,Iowa Gambling Task(IGT),NIRS,p-50,serum brain-derived neurotrophic factor (BDNF), serum amino acids

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Placebo
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
Behavior,custom Maneuver
Interventions/Control_1 Participants were randomly assigned to waiting list or individual CBT guided self-care supported by therapists. Therapists were regularly supervised by professional CBT psychiatrists or psychologists.
Interventions/Control_2 Participants assigned to waiting list received treatment as usual (TAU).
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
7 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria Participants were recruited at the Department of Psychiatry, Department of Child Psychiatry, Chiba University Hospital. Written informed consent was sought from participants. They were 7-75 years of age, met DSM-IV criteria for anxiety disorders, obsessive compulsive disorders, bulimia nervosa, depressive disorders and related disorders.
Key exclusion criteria We excluded patients with a body mass index below 15, patients suffering from severe mental illness, or substance dependence, pervasive developmental disorders, learning disability, severe physical illness, at risk for self-injury or suicidal attempt, patients with GAF score below 50, mental retardation and mental disability (IQ<80).
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaomi Iyo
Organization Chiba University Graduate School of Medicine, Chiba
Division name Department of Psychiatry
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba 2608677 JAPAN
TEL 043-226-2297
Email

Public contact
Name of contact person
1st name
Middle name
Last name Michiko Nakaztao
Organization Chiba University Hospital
Division name Department of Child Psychiatry
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba 2608677 JAPAN
TEL 043-226-2297
Homepage URL
Email nakazato@faculty.chiba-u.jp

Sponsor
Institute Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba
Institute
Department

Funding Source
Organization Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Integrative Neurophysiology
Chiba University Graduate School of Medicine
Name of secondary funder(s) Division of Clinical Neuroscience, ChibaUniversity Center for Forensic Mental Health

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 千葉大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2010 Year 04 Month 01 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
2010 Year 03 Month 12 Day
Date of IRB
Anticipated trial start date
2010 Year 04 Month 01 Day
Last follow-up date
2015 Year 03 Month 01 Day
Date of closure to data entry
2015 Year 03 Month 01 Day
Date trial data considered complete
2015 Year 03 Month 01 Day
Date analysis concluded
2016 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 03 Month 13 Day
Last modified on
2015 Year 06 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004021

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.