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The Only 3-in-1 Medical Food for Depression

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Press and Facts

Press and company facts

Please use verbatim:
HedoniaUSA Inc. is a Bethesda, Maryland company and the maker of Hedonia, a medical food for the dietary management of nutritional deficiencies associated with depression, intended for use under a physician’s supervision. Hedonia combines three nutrients with published research in depression: EPA omega-3, L-methylfolate and SAMe. The rationale for the combination is set out in a 2024 peer-reviewed paper in Nutrients. HedoniaUSA Inc. is not connected to Hedonia Ltd (the Mood Bloom app) or to Hedonia Clinic in the United Kingdom.
Short version, for use where space is limited:
HedoniaUSA Inc. of Bethesda, Maryland makes Hedonia, a medical food for the dietary management of nutritional deficiencies associated with depression, taken under a physician’s supervision.

Fast facts

Company
HedoniaUSA Inc.
Headquarters
Bethesda, Maryland, United States
Founder
Dr. Alexander Vuckovic, MD, psychiatrist. Assistant professor of psychiatry, part-time, at an Ivy League medical school
Chief Executive Officer
Dany Sfeir
Product

Hedonia, a 3-in-1 medical food for the dietary management of nutritional deficiencies associated with depression

Regulatory category
Medical food (United States). Not a dietary supplement and not a drug
Daily dose
Four capsules, taken as two capsules twice a day with food
Formulation, per day
EPA omega-3 (OmegaTex®) 1,440 mg, from 1,800 mg total omega-3; L-methylfolate glucosamine (Quatrefolic®) 20 mg, providing 15 mg L-methylfolate; SAMe (Adonat® Premium) 1,200 mg
Formulation, per capsule
EPA 360 mg, from 450 mg total omega-3; DHA 9 mg; Quatrefolic® 5 mg, providing 3.75 mg L-methylfolate; SAMe 300 mg
Peer-reviewed foundation
Tobin D, Vuckovic A, Sarris J. Targeting divergent pathways in the nutritional management of depression. Nutrients. 2024;16(16):2806. doi:10.3390/nu16162806. PMID: 39203943
Clinical research
No trial of the finished 3-in-1 formulation has yet reported. A trial is being commissioned with Clinical Research Australia and is not yet registered. Randomised controlled trial evidence exists for each of the three nutrients individually in depression. NCT05685758 is a study of a mobile phone application sponsored by the unrelated Hedonia Ltd
Patents
US 8,372,451, granted 12 February 2013, and US 9,662,359, granted 30 May 2017, both titled “Compositions and methods for treating depression”. Named inventor Alexander Vuckovic; assignee Alexander Vuckovic MD LLC. Hedonia is stated on the product label as protected by both
Scientific advisors
Dr. Alexander Vuckovic, MD; Derek Tobin; Professor Jerome Sarris; Professor Joseph Firth
Website
hedonia.com
Where to buy
Direct from hedonia.com, and on Amazon, sold by the Hedonia Store, ASIN B0FZ924YM9

Note for editors: research on these nutrients is normally reported per day, and product labels are normally written per capsule. Both sets of figures are given above so that neither is mistaken for the other. Where this page gives an amount without saying which, it is the daily amount.

Leadership and Advisors

Dr. Alexander Vuckovic, MD, Founder. A psychiatrist with more than 35 years of clinical experience, and an assistant professor of psychiatry, part-time, at an Ivy League medical school. Named inventor on both US patents behind the formulation. Profile

Dany Sfeir, Chief Executive Officer & Co-Founder (since 1 November 2023). A consumer goods executive with a record of building brands to substantial revenue across several categories.

Professor Jerome Sarris, Scientific Advisor. Executive Director of the Psychae Institute. Lead author of the 2022 WFSBP and CANMAT clinician guidelines on nutraceuticals and phytoceuticals in psychiatric disorders, and co-author of the ISNPR practice guidelines on omega-3 fatty acids in major depressive disorder. Profile

Derek Tobin, PhD, Scientific Advisor. Lead author of the 2024 Nutrients paper. Product Development and Clinical Science Manager at Epax Norway, formerly of GE Healthcare and BASF. Profile

Professor Joseph Firth, PhD, Scientific Advisor. Professor of Psychology and Mental Health at a leading UK university, whose research focuses on nutrition, exercise and lifestyle interventions in the treatment of mental illness. Chair of the Lancet Commission on Physical Health in Mental Illness. Profile

What Hedonia is, and is not

Included on the press page deliberately. It saves journalists from guessing, and guessing is where inaccurate coverage begins.
Hedonia is a medical food, a distinct regulatory category in the United States for products formulated to manage the nutritional requirements of a specific condition under a physician’s supervision.
Hedonia is not a drug, not an antidepressant, and not a dietary supplement. It does not replace antidepressant medication or therapy, and it is designed to be used alongside existing treatment.
No trial of the complete Hedonia formulation has yet reported, and the published evidence concerns the three constituent nutrients individually in depression. Coverage should reflect that distinction. A trial of the finished formulation is being commissioned with Clinical Research Australia; it is not yet registered, it has produced no findings, and it should not be reported as being under way or as evidence of anything.
All three nutrients are assessed in the 2022 clinician guidelines of the World Federation of Societies of Biological Psychiatry and the Canadian Network for Mood and Anxiety Treatments, which give adjunctive omega-3 fatty acids their strongest rating for any nutrient in unipolar depression. A systematic review and meta-analyses in the American Journal of Psychiatry concluded that current evidence supports the adjunctive use of SAMe, methylfolate and omega-3 with antidepressants to reduce depressive symptoms. Those findings should be reported as given.
One point that is regularly reported incorrectly. A search of the ClinicalTrials.gov registry for “Hedonia” returns NCT05685758, a completed depression trial of a mobile phone application. That study is sponsored by Hedonia Ltd, an unrelated company. It is not a study of the Hedonia medical food and it is not a study by HedoniaUSA Inc.

Media contact

Media enquiries: press@hedoniausa.com

General enquiries: customerservice@hedoniausa.com

Hedonia® is classified (and regulated) in the USA as a medical food product.

Hedonia is intended to be used under medical supervision alongside an individual’s physician-directed treatment.

Each gel-capsule contains a total omega-3 triglyceride content of 640mg of which EPA is 400mg, 400mg of Adonat® Premium SAMe Stabilized PowdeR, and 3.75mg of Quatrefolic® ((6S)-5-methyltetrahydrofolic acid).

Ingredients:

Mono and diglycerides of fatty acids, Lemon natural flavor, sunflower lecithin, gelatin, Firming agent: glycerol, colorant: Titanium dioxide, Coloring: allura red, yellow-orange, and brilliant blue FCF