Clinical trial NCT02553915 (phase 2/phase 3, status: active, not recruiting)
Conditions: major depressive disorder, overweight, inflammation
ICD codes: F33.0, F33.1, F33.9, F32.0, F32.1, F32.9, F33.40, E66.3, H01.9, H30.93, H05.00, H30.003, H30.013, H30.033, H30.103
Drugs: epa 1 g/day, epa 2 g/day, epa 4 g/day
SMILES: CC\C=C/C\C=C/C\C=C/C\C=C/C\C=C/CCCC(O)=O, CC\C=C/C\C=C/C\C=C/C\C=C/C\C=C/CCCC(O)=O, CC\C=C/C\C=C/C\C=C/C\C=C/C\C=C/CCCC(O)=O
Eligibility criteria:

        Inclusion Criteria:

          -  Able to provide informed consent.

          -  Men or women aged 18-80 years.

          -  A primary psychiatric diagnosis of major depressive disorder (MDD), by Diagnostic and
             Statistical Manual-5th ed (DSM-5) using the Mini International Neuropsychiatric
             Interview (MINI v.7.0).

          -  A Screening and Baseline visit Inventory of Depressive Symptoms, Clinician rated
             (IDS-C30) total score ≥ 25.

          -  Currently overweight at screening, defined as BMI > 25 kg/m2.

          -  Screening visit high-sensitivity C-reactive protein concentration ≥ 3 mg/L.

          -  Willing to not significantly modify their diet from the time they sign consent through
             the end of study participation.

        Exclusion Criteria:

          -  Use of any psychotropic agents within 2 weeks of baseline or at any time during the
             study, with the exception of prescription hypnotics (eszopiclone, zaleplon, zolpidem,
             suvorexant, ramelteon), diphenhydramine, or a stable daily dose of a benzodiazepine.

          -  Breastfeeding or pregnant women, women intending to become pregnant within 6 months of
             the screening visit, or women of child bearing potential who are not using a medically
             accepted means of contraception (defined as oral contraceptive pill or implant,
             condom, diaphragm, intrauterine device (IUD), status-post tubal ligation, or partner
             with vasectomy)

          -  Patients who, in the investigator's judgement, pose a current, serious suicidal or
             homicidal risk.

          -  Serious or unstable medical illness that in the investigator's opinion could
             compromise response to treatment or interpretation of study results.

          -  History of seizure disorder, except for childhood febrile seizures.

          -  Meeting DSM-5 criteria at any point in their lifetime, for any of the following:
             Neurocognitive Disorder, Psychotic Disorder, Bipolar disorder, Anorexia Nervosa

          -  Meeting DSM-5 criteria in the 3 months prior to the screening visit for any Substance
             Use Disorder (except nicotine or caffeine).

          -  Meeting DSM-5 criteria at screening for current obsessive compulsive disorder or
             bulimia nervosa.

          -  Presence of psychotic features at any time during the current major depressive
             episode.

          -  Any conditions or medications (within 1 week of baseline or during the trial) that
             might confound the biomarker findings, including: Regular ingestion of NSAIDs or
             Cyclooxygenase-2 (COX-2) inhibitors, or any use of oral steroids, immunosuppressants,
             interferon, chemotherapy, or anticoagulants (Patients will be instructed not to take a
             nonsteroidal antiinflammatory drug (NSAID) or COX-2 inhibitor in the 24 hours prior to
             a biomarker assessment visit), Malignancy not in remission for at least 1 year, Active
             autoimmune disorder or inflammatory bowel disease, Insulin-dependent diabetes
             mellitus.

          -  History of allergy to PUFA supplements.

          -  Laboratory evidence of undiagnosed hypothyroidism or change in treatment for
             hypothyroidism in the 3 months prior to screening.

          -  Patients who have failed to respond during the course of their current major
             depressive episode to >4 adequate antidepressant trials, defined as six weeks or more
             of treatment with the FDA-defined minimally effective dose.

          -  Patients who have taken a supplement of at least 1 g/day of omega 3 fatty acids for at
             least 6 weeks during the current major depressive episode.

          -  Patients who have had electroconvulsive therapy (ECT) during the current depressive
             episode or within 6 months of the screening visit.

          -  Patients who have taken supplements with omega-3 fatty acids (see Appendix A for list
             of products) within sixty (60) days of the screening visit.

          -  Patients who, at baseline, are consuming a diet that contains more than 3g/day of
             omega-3 FA, or who consume more than 3 meals of fatty fish per week.

          -  Patients who have a history of a bleeding disorder.

          -  Patients who have participated in another clinical trial of an investigational
             medication within 1 month of the screening visit.

          -  Patients who are currently in psychotherapy that was initiated within 90 days prior to
             the study screening visit.