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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005896
Receipt No. R000006952
Scientific Title The effect of psychoeducation for the prevent from recurrence of major depression and familial expressed emotion.
Date of disclosure of the study information 2011/07/01
Last modified on 2013/01/04

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Basic information
Public title The effect of psychoeducation for the prevent from recurrence of major depression and familial expressed emotion.
Acronym The effect of psychoeducation for major depression
Scientific Title The effect of psychoeducation for the prevent from recurrence of major depression and familial expressed emotion.
Scientific Title:Acronym The effect of psychoeducation for major depression
Region
Japan

Condition
Condition major depression
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 the effect of psychoeducation for prevent from recurrence of major depression
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Hamilton Rating Scale for Depression 17-items(DRSD-17), Beck Depression Inventory-Second Edition(BDI-II); before and after psychoeducational sessions, after 9 and 24 months
Clinical Global Impression(CGI), Global Assessment of Functioning(GAF); before psychoeducational sessions, after 9 and 24 months
Relapse
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Control group; only usual medication and supportive psychotherapy
Interventions/Control_2 Inetervention group; 6 psychoeducational sessions with using the videos and textbook, usual medication and supportive psychotherapy
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. diagnosis of major depressive disorder according to the DSM-IV criteria (APA, 2000);
2. patient not having undergone electroconvulsive therapy (ECT), or not having ECT already planned for the index episode.
Key exclusion criteria 1. suspected to have experienced hypomanic/manic episode
2. diagnosed to have Axis II disorders
3. severe physical illness.
4. the Mini-Mental State Examination (Folstein et al., 1975) when their age was over 60 and they were excluded if the score was 23 or below.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinji Shimodera
Organization Kochi Medical School
Division name Dept. of Neuropsychiatry
Zip code
Address Kohasu, Oko-cho, Nankoku City, Kochi, Japan
TEL 088-880-2359
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shinji Shimodera
Organization Kochi Mecial School
Division name Dept. of Neuropsychiatry
Zip code
Address Kohasu, Oko-cho, Nankoku City, Kochi, Japan
TEL 088-880-2359
Homepage URL
Email shimodes@kochi-u.ac.jp

Sponsor
Institute Dept. of Neuropsychiatry, Kochi Medical School
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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 高知大学医学部附属病院(高知県),愛宕病院(高知県),藤戸病院(高知県)

Other administrative information
Date of disclosure of the study information
2011 Year 07 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 Completed
Date of protocol fixation
2007 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 06 Month 01 Day
Last follow-up date
2012 Year 04 Month 01 Day
Date of closure to data entry
2012 Year 08 Month 31 Day
Date trial data considered complete
2012 Year 08 Month 31 Day
Date analysis concluded
2012 Year 12 Month 30 Day

Other
Other related information

Management information
Registered date
2011 Year 06 Month 30 Day
Last modified on
2013 Year 01 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006952

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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