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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005555
Receipt No. 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 2011/05/04

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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
Email

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
Email

Sponsor
Institute Department of Neuropsychiatry, Kochi Medical School
Institute
Department

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
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
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 Completed
Date of protocol fixation
2004 Year 03 Month 01 Day
Date of IRB
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

Management information
Registered date
2011 Year 05 Month 04 Day
Last modified on
2011 Year 05 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006585

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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