UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005896 |
|---|---|
| Receipt number | 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 15:32:17 |
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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
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
shimodes@kochi-u.ac.jp
Sponsor or person
Institute
Dept. of Neuropsychiatry, Kochi Medical School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006952
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
