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Augmentation of omega-3 fatty acid with antidepressants for major depressive disorder: a double-blind, randomized controlled trial

Augmentation of omega-3 fatty acid with antidepressants for major depressive disorder: a double-blind, randomized controlled trial - SAKANA for relieving depression in patients taking escitalopram (Sardine study)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000013525
Enrollment
60
Registered
2014-04-01
Start date
2014-04-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

major depressive disorder

Interventions

Omega-3 Polyunsaturated fatty acid placebo

Sponsors

University of Occupational and Environmental Health
Lead Sponsor
National Center of Neurology and Psychiatry University of Toyama Tohoku Medical Megabank Organization, Tohoku University Tohoku Fukushi University Hakatachikushiguchi cocoro clinic
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Hamilton Raing Scale for Depression[Time frame: 12 weeks]

Secondary

MeasureTime frame
MADRS SDS BDI QIDS-J CGI-S RS-14 Serum BDNF, proBDNF, MMP-9, fatty acid level Plasma IL-6

Countries

Japan

Contacts

Public ContactWakako Nakano

University of Occupational and Environmental Health Department of Psychiatry

wakako-u@med.uoeh-u.ac.jp093-691-7253

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026