UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014755 |
|---|---|
| Receipt number | R000017153 |
| Scientific Title | Omega-3 polyunsaturated fatty acids and psychological interventions for workers with mild to moderate depression: a randomized controlled trial |
| Date of disclosure of the study information | 2014/09/01 |
| Last modified on | 2021/05/19 17:04:13 |
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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
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
jtayama@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017153
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