UMIN-CTR Clinical Trial

Basic information
Public title	The effect of family psychoeducation in depression
Acronym	The effect of family psychoeducation in depression
Scientific Title	The effect of family psychoeducation in depression
Scientific Title:Acronym	The effect of family psychoeducation in depression
Region	Japan

Condition
Condition	Depression
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Confirm that the effect of family psychoeducation on improvement of prognosis of depression
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	the rate of recurrence of the depression during 9 moths
Key secondary outcomes	BDI (Beck Depression Inventory) HAM-D (Hamilton Rating Scale for Depression) CGI (Clinical Global Impressions) FMSS (Five Minute Speech Sample) FAS (Family Attitude Scale) GHQ-12(General Health Questionnaire)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Group of Family Psychoeducation
Interventions/Control_2	Group of non Family Psychoeducation (Control)
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients diagnosed by DSM-V Patients and their family
Key exclusion criteria	None
Target sample size	125

Research contact person
Name of lead principal investigator	1st name Hirokazu Middle name Last name Fujita
Organization	Kochi Medical School
Division name	Center to Promote Creativity in Medical Education
Zip code	7838505
Address	Kohasu, Oko-cho, Nankoku, Kochi
TEL	088-880-2291
Email	fujitah@kochi-u.ac.jp

Public contact
Name of contact person	1st name Hirokazu Middle name Last name Fujita
Organization	Kochi Medical School
Division name	Center to Promote Creativity in Medical Education
Zip code	7838505
Address	Kohasu, Oko-cho, Nankoku, Kochi
TEL	088-880-2291
Homepage URL
Email	fujitah@kochi-u.ac.jp

Sponsor
Institute	Kochi Medical School
Institute
Department

Funding Source
Organization	Japan Society for the promotion of science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethical Review Board of Kochi Medical School
Address	Kohasu, Oko-cho, Nankoku, Kochi
Tel	088-866-5811
Email	rinri21@kochi-u.ac.jp

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	2015 Year 10 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	2015 Year 09 Month 30 Day
Date of IRB	2015 Year 10 Month 27 Day
Anticipated trial start date	2015 Year 10 Month 27 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry	2020 Year 03 Month 31 Day
Date trial data considered complete	2020 Year 03 Month 31 Day
Date analysis concluded	2020 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date	2015 Year 08 Month 28 Day
Last modified on	2020 Year 04 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021791