UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013525 |
|---|---|
| Receipt number | R000015776 |
| Scientific Title | Augmentation of omega-3 fatty acid with antidepressants for major depressive disorder: a double-blind, randomized controlled trial |
| Date of disclosure of the study information | 2014/04/01 |
| Last modified on | 2014/04/03 19:47:31 |
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Basic information
Public title
Augmentation of omega-3 fatty acid with antidepressants for major depressive disorder: a double-blind, randomized controlled trial
Acronym
SAKANA for relieving depression in patients taking escitalopram (Sardine study)
Scientific Title
Augmentation of omega-3 fatty acid with antidepressants for major depressive disorder: a double-blind, randomized controlled trial
Scientific Title:Acronym
SAKANA for relieving depression in patients taking escitalopram (Sardine study)
Region
| Japan |
Condition
Condition
major depressive disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine the efficacy of augmentation of omega-3 fatty acid with escitalopram in patients with major depressive disorder.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Hamilton Raing Scale for Depression[Time frame: 12 weeks]
Key secondary outcomes
MADRS
SDS
BDI
QIDS-J
CGI-S
RS-14
Serum BDNF, proBDNF, MMP-9, fatty acid level
Plasma IL-6
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Omega-3 Polyunsaturated fatty acid
Interventions/Control_2
placebo
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
1. The subject did not receive any antidepressant drugs(≥4 weeks at minimal effective dose) for major depression
2. Total HDRS-17 score ≥17
3. The major depressive episode is the focus of the treatment and the treating physician has judged escitalopram to be its appropriate 1st line drug
4. A native Japanese speaker
5. The participant is able to understand and sign written informed consent.
Key exclusion criteria
1. History of schizophrenia, schizoaffective disorder or bipolar disorder (DSM-IV) as judged by treating physician.
2. Current dementia, borderline personality disorder, eating disorder or substance dependence (DSM-IV) as judged by treating physician.
3. Imminent high risk of suicide as judged by treating physician.
4. Use of antipsychotic drugs and antidepressant drugs within 1 week of the visit
5. Physical diseases which may contraindicate treatment with escitalopram.
6. Currently pregnant or breast-feeding women
7. Regular consumption of polyunsaturated fatty acid supplements within the last 3 months
8. A habit of eating fish >= 4 times per week, to ensure comparability to patients studied in Western countries.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Wakako Nakano |
Organization
University of Occupational and Environmental Health
Division name
Department of Psychiatry
Zip code
Address
1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu, Fukuoka 807-8555, Japan
TEL
093-691-7253
wakako-u@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Wakako Nakano |
Organization
University of Occupational and Environmental Health
Division name
Department of Psychiatry
Zip code
Address
1-1, Iseigaoka, Yahatanishi-ku, Kitakyushu, Fukuoka 807-8555, Japan
TEL
093-691-7253
Homepage URL
wakako-u@med.uoeh-u.ac.jp
Sponsor or person
Institute
University of Occupational and Environmental Health
Institute
Department
Personal name
Funding Source
Organization
University of Occupational and Environmental Health
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Center of Neurology and Psychiatry
University of Toyama
Tohoku Medical Megabank Organization, Tohoku University
Tohoku Fukushi University
Hakatachikushiguchi cocoro clinic
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
| 2014 | Year | 04 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 03 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 27 | Day |
Last modified on
| 2014 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015776
