UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005555 |
|---|---|
| Receipt number | R000006585 |
| Scientific Title | Family psychoeducation to prevent relapse/recurrent in the maintenance treatment of major depression: a randomized controlled trial |
| Date of disclosure of the study information | 2011/05/09 |
| Last modified on | 2022/07/22 09:31:29 |
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Basic information
Public title
Family psychoeducation to prevent relapse/recurrent in the maintenance treatment of major depression: a randomized controlled trial
Acronym
Family psychoeducation for major depression
Scientific Title
Family psychoeducation to prevent relapse/recurrent in the maintenance treatment of major depression: a randomized controlled trial
Scientific Title:Acronym
Family psychoeducation for major depression
Region
| Japan |
Condition
Condition
Major depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of family psychoeducation to prevent relapse/recurrence in the maintenance treatment of major depression
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relapse/recurrence of a major depressive episode
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Family psychoeducation in addition to treatment as usual
Interventions/Control_2
Treatment as usual only
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Diagnosed as suffering from major depressive disorder according to the DSM-IV
2. Expected to be on continuation/maintenance antidepressant therapy for at least nine months after the patients had responded to acute phase antidepressant therapy and were in partial or full remission, i.e. they no longer fulfilled the diagnostic threshold for major depressive episode
3. Not having undergone electroconvulsive therapy or not having electroconvulsive therapy already planned for the index episode
4. Living with the family for 3 months or longer before participating in this study and being expected to live with the family during the investigation period
5. Having at least one family member living with the patient who was available for family interviews.
Key exclusion criteria
1. Patients were screened with the Mini-Mental Status Examination 11 when dementia was clinically suspected and those scoring 23 or below were excluded.
2. Patients suspected of having organic diseases were examined by head magnetic resonance imaging, and those diagnosed as such were excluded.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinji Shimodera |
Organization
Kochi Medical School
Division name
Department of Neuropsychiatry
Zip code
Address
Kohasu, Okoh-cho, Nankoku-shi, Kochi 783-8505 Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kochi Medical School
Division name
Department of Neuropsychiatry
Zip code
Address
Kohasu, Okoh-cho, Nankoku-shi, Kochi 783-8505 Japan
TEL
Homepage URL
Sponsor or person
Institute
Department of Neuropsychiatry, Kochi Medical School
Institute
Department
Personal name
Funding Source
Organization
Grand-in-Aid for Scientific Research, Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://bjp.rcpsych.org/
Number of participants that the trial has enrolled
Results
Time to relapse was statistically significantly longer in the psychoeducation group than in the control group (Kaplan-Meier survival analysis, p=0.002). The relapse rate up to the 9-month follow-up was 8.3% and 50.0%, respectively (RR=0.17, 95%CI: 0.04 to 0.66; NNT=2.4, 95%CI: 1.6 to 4.9). In Cox proportional hazard analysis, baseline EE did not moderate the effectiveness of the intervention.
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
Main results already published
Date of protocol fixation
| 2004 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2004 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2004 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 12 | Month | 01 | Day |
Other
Other related information
Shimazu K, Shimodera S, Mino Y, Nishida A, Kamimura N, Sawada K, Fujita H, Furukawa TA & Inoue S (2011) Family psychoeducation for major depression: Randomised controlled trial. British Journal of Psychiatry, 198, 385-390.
Shimodera S, Furukawa TA, Mino Y, Shimazu K, Nishida A & Inoue S (2012) Cost-effectiveness of family psychoeducation to prevent relapse in major depression: Results from a randomized controlled trial. BMC Psychiatry, 12, 40.
Management information
Registered date
| 2011 | Year | 05 | Month | 04 | Day |
Last modified on
| 2022 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006585
| Research Plan | |
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| 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 |
