UMIN-CTR Clinical Trial

Basic information
Public title	Omega-3 polyunsaturated fatty acids and psychological interventions for workers with mild to moderate depression: a randomized controlled trial
Acronym	Healing worker's depression by omega-3 polyunsaturated fatty acids and psychological interventions: a randomized controlled trial
Scientific Title	Omega-3 polyunsaturated fatty acids and psychological interventions for workers with mild to moderate depression: a randomized controlled trial
Scientific Title:Acronym	Healing worker's depression by omega-3 polyunsaturated fatty acids and psychological interventions: a randomized controlled trial
Region	Japan

Condition
Condition	Job stress
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the efficacy of omega-3 fatty acids supplementation for psychological distress and depressive symptoms by comparing the outcome of the groups of omega-3 fatty acids supplementation added to psychological interventions and psychological interventions alone in workers
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	Beck depression Inventory-II
Key secondary outcomes	-Kessler K6 -The Center for Epidemiologic Studies -Depression Scale (CES-D)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation
Institution consideration
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Psychological interventions + Omega-3 Polyunsaturated Fatty Acids
Interventions/Control_2	Psychological interventions
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	Japanese workers -A native Japanese speaking ability -Those who can understand scope and contents in the trial
Key exclusion criteria	Us of warfarin within 3 month at regular intervals
Target sample size	78

Research contact person
Name of lead principal investigator	1st name Susumu Middle name Last name Shirabe
Organization	Nagasaki University
Division name	Center for Health and Community Medicine
Zip code	852-8521
Address	1-14 Bunkyo, Nagasaki 852-8521
TEL	095-819-2214
Email	shirabe@nagasaki-u.ac.jp

Public contact
Name of contact person	1st name Jun Middle name Last name Tayama
Organization	Nagasaki University
Division name	Graduate School of Education
Zip code	852-8521
Address	1-14 Bunkyo, Nagasaki 852-8521
TEL	095-819-2214
Homepage URL
Email	jtayama@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki University
Institute
Department

Funding Source
Organization	Japan society for the promotion of science
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Health Sciences University of Hokkaido University of Toyama Saitama Prefectural University Tohoku University Tohoku Fukushi University Kurume University
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Committee of Nagasaki University Graduate School of Biomedical Sciences
Address	852-8523, 1-12-4, Sakamoto, Nagasaki
Tel	095-819-7198
Email	gakujutu_kikaku@ml.nagasaki-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	長崎大学保健・医療推進センター（長崎県）、埼玉県立大学保健医療福祉学部（埼玉県）、別府大学文学部（大分県）

Other administrative information
Date of disclosure of the study information	2014 Year 09 Month 01 Day

Related information
URL releasing protocol	https://www.sciencedirect.com/science/article/pii/S0165032718312400?via%3Dihub
Publication of results	Unpublished

Result
URL related to results and publications	https://www.sciencedirect.com/science/article/pii/S0165032718312400?via%3Dihub
Number of participants that the trial has enrolled	90
Results	After 12 weeks of treatment, BDI-II scores were significantly lower in the placebo and omega-3 group, when compared to their respective baseline scores (Placebo: t=-4.6, p<0.01; Omega-3: t=-7.3, p<0.01). However, after 12 weeks of treatment, we found no significant difference between both groups with respect to changes in the BDI-II scores (0.7; 95% CI, -0.7 to 2.1; p=0.30).
Results date posted	2021 Year 05 Month 19 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Workers with moderate depressive symptoms
Participant flow	For potential participants assessed for eligibility, the degree of depressive symptoms was confirmed, and those with moderate symptoms were selected. Subsequently, 90 subjects who consented to the study were randomized to 47 in the intervention group and 43 in the control group.
Adverse events	Not applicable
Outcome measures	BDI-II
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 25 Day
Date of IRB	2014 Year 09 Month 11 Day
Anticipated trial start date	2014 Year 10 Month 06 Day
Last follow-up date	2015 Year 12 Month 31 Day
Date of closure to data entry	2016 Year 01 Month 31 Day
Date trial data considered complete	2016 Year 02 Month 29 Day
Date analysis concluded	2016 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2014 Year 08 Month 04 Day
Last modified on	2021 Year 05 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017153