{ "_comment": "Machine-readable product facts for Hedonia. Publish at https://hedonia.com/facts/hedonia.json and link it from the product page and the press page. This file is the single source of truth: when any fact changes, change it here first, then update the page copy, the schema blocks and the label to match. All values are confirmed. The only fields still to supply are asset and profile URLs, which are listed in the placeholder register and do not appear in this file.", "_dose_convention": "IMPORTANT. Research on these nutrients is reported per day; product labels are written per capsule. Both are given below and each is labelled. Any amount stated elsewhere on this site without a qualifier is the daily amount.", "entity": "Hedonia", "type": "Medical food", "regulatory_category_notes": "Medical food as defined in the United States: a food formulated for the dietary management of a specific condition with distinctive nutritional requirements, intended for use under the supervision of a physician. Not a dietary supplement. Not a drug.", "regulatory_basis": [ "21 USC 360ee(b)(3)", "21 CFR 101.9(j)(8)", "FDA Guidance for Industry: Frequently Asked Questions About Medical Foods, Third Edition, March 2023 (Docket FDA-2013-D-0880)" ], "company": { "name": "HedoniaUSA Inc.", "location": "Bethesda, Maryland, United States", "address": "7475 Wisconsin Ave, Suite 1100, Bethesda, MD 20814", "website": "https://hedonia.com", "founder": { "name": "Dr. Alexander Vuckovic, MD", "role": "Founder and Chief Scientific Officer", "academic_appointment": "Assistant Professor of Psychiatry, part-time, Harvard Medical School", "clinical_appointment": "Medical Director, The Pavilion, McLean Hospital, Belmont, Massachusetts", "board_certification": "Diplomate, American Board of Psychiatry and Neurology", "professional_fellowship": "Distinguished Life Fellow, American Psychiatric Association", "orcid": "0000-0002-7352-4070", "sameAs": [ "https://www.mcleanhospital.org/profile/alexander-vuckovic", "https://www.massgeneralbrigham.org/en/doctors/v/alexander-vuckovic-3007011", "https://connects.catalyst.harvard.edu/Profiles/display/Person/32142", "https://orcid.org/0000-0002-7352-4070" ] }, "chief_executive": "Dany Sfeir, appointed 1 November 2023", "_founded_note": "Founding year not published in any public record located as at July 2026. Omitted rather than estimated." }, "intended_use": "Dietary management of nutritional deficiencies associated with depression, under a physician's supervision.", "is_not": [ "a dietary supplement", "a drug or an antidepressant", "a replacement for antidepressant medication or therapy", "connected to Hedonia Ltd, maker of the Mood Bloom app, which has registered its own depression trial (NCT05685758)", "connected to Hedonia Clinic in the United Kingdom", "connected to HEDONIA SAS of Rosheim, France, a timber frame and joinery manufacturer", "related to the clinical term 'anhedonia'" ], "directions": "Take two capsules twice a day with food, or as directed by a physician. Four capsules daily. Available without a prescription, but intended for use under a doctor's supervision.", "capsules_per_day": 4, "formulation_per_day": { "basis": "Four capsules, one full day's dose", "EPA_omega_3": { "branded_form": "OmegaTex®", "amount_mg": 1440 }, "EPA_predominance": "Ultra-high-EPA formulation. EPA predominates over DHA.", "total_omega_3_mg": 1800, "DHA_mg": 36, "L_methylfolate": { "branded_form": "Quatrefolic®", "chemical_form": "L-methylfolate glucosamine", "amount_as_supplied_mg": 20, "active_L_5_MTHF_equivalent_mg": 15, "active_equivalent_confirmed_by": "HedoniaUSA, July 2026, consistent with the published product label", "note": "The two figures describe the same thing: the branded ingredient as supplied, and the amount of the active form it delivers." }, "SAMe": { "branded_form": "Adonat® Premium", "amount_mg": 1200 } }, "formulation_per_capsule": { "EPA_mg": 360, "total_omega_3_mg": 450, "other_omega_3_mg": 81, "DHA_mg": 9, "L_methylfolate_as_supplied_mg": 5.0, "L_methylfolate_active_equivalent_mg": 3.75, "SAMe_mg": 300 }, "other_ingredients": [ "Gellan gum", "Hypromellose", "Aerosil 200F", "Sodium copper chlorophyllin" ], "safety": { "_note": "Wording below reflects the current professional reference sources as at July 2026. Pending HedoniaUSA regulatory review before publication; this is the only outstanding item in this file.", "tell_your_doctor": "Tell your doctor about every medicine you take before starting Hedonia, in particular any antidepressant.", "do_not_use": [ "during pregnancy or while breastfeeding", "with bipolar disorder", "alongside MAOI antidepressants, or within 14 days of stopping one" ], "use_with_caution": [ "alongside anticoagulant (blood-thinning) medication; speak to a doctor first", "alongside levodopa for Parkinson's disease", "before surgery; stop taking Hedonia two weeks beforehand" ], "possible_effects": "In trials, side effects from these nutrients have generally been mild and no more common than with placebo, most often stomach upset or headache. Some people notice changes in sleep.", "supervision": "Intended for use under a physician's supervision. Not a replacement for prescribed treatment; do not stop or change prescribed medication without medical advice.", "adjunctive_use": "Hedonia is designed to be used alongside antidepressant treatment, not instead of it, and under a doctor's supervision. Adjunctive use of these nutrients has been assessed in the 2022 WFSBP and CANMAT clinician guidelines." }, "evidence": { "summary": "Published research exists for each of the three nutrients individually in depression. All three are assessed in the 2022 WFSBP and CANMAT clinician guidelines for unipolar depression, which give adjunctive omega-3 their strongest rating for any nutrient and do not recommend plain folic acid. 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, with primarily positive results in replicated studies for all three.", "dose_alignment": { "_note": "Each daily amount against the amount used in the supporting research. This describes formulation design, not efficacy of the finished product.", "EPA": "1,440 mg daily, inside the 1 to 2 g range recommended by the ISNPR practice guidelines and the range where the 2023 meta-analysis found an effect. No significant effect was found at 2 g or more.", "EPA_proportion": "An ultra-high-EPA formulation, above the threshold associated with benefit.", "L_methylfolate": "15 mg daily, matching the trial arm that showed an effect when added to an SSRI (number needed to treat approximately six). A companion trial at 7.5 mg daily did not show the same effect.", "SAMe": "1,200 mg daily, within the range used across published trials. Included as a synergistic partner to the omega-3 and the methylfolate, on the divergent-pathways rationale set out in the 2024 Nutrients review." }, "peer_reviewed_rationale": { "citation": "Tobin D, Vuckovic A, Sarris J. Targeting divergent pathways in the nutritional management of depression. Nutrients. 2024;16(16):2806.", "doi": "10.3390/nu16162806", "pubmed": "https://pubmed.ncbi.nlm.nih.gov/39203943/", "type": "Narrative review", "limits": "A review of the published research, not a study of Hedonia. It sets out the rationale for the combination and is not evidence that the product works.", "disclosure": "The paper carries a standard disclosure that two authors advise HedoniaUSA and one founded the company." }, "key_references": [ { "role": "International clinical guideline", "citation": "Sarris J, Ravindran A, Yatham LN, et al. WFSBP and CANMAT Taskforce clinician guidelines. World J Biol Psychiatry. 2022;23(6):424-455.", "doi": "10.1080/15622975.2021.2013041", "pmid": "35311615" }, { "role": "Meta-review of meta-analyses", "citation": "Firth J, Teasdale SB, Allott K, Siskind D, Marx W, Cotter J, et al. The efficacy and safety of nutrient supplements in the treatment of mental disorders: a meta-review of meta-analyses of randomized controlled trials. World Psychiatry. 2019;18(3):308-324.", "doi": "10.1002/wps.20672", "pmcid": "PMC6732706", "keyFinding": "Thirty-three meta-analyses, 10,951 individuals. Strongest evidence for omega-3, particularly eicosapentaenoic acid, as an adjunctive treatment for depression; positive effects from trials of high-dose methylfolate in major depressive disorder." }, { "role": "Omega-3 practice guideline", "citation": "Guu TW, Mischoulon D, Sarris J, et al. ISNPR practice guidelines for omega-3 fatty acids in major depressive disorder. Psychother Psychosom. 2019;88(5):263-273.", "doi": "10.1159/000502652", "pmid": "31480057" }, { "role": "Omega-3 meta-analysis, current", "citation": "Kelaiditis CF, Gibson EL, Dyall SC. Prostaglandins Leukot Essent Fatty Acids. 2023;192:102572.", "doi": "10.1016/j.plefa.2023.102572", "pmid": "37028202" }, { "role": "L-methylfolate adjunctive trials", "citation": "Papakostas GI, Shelton RC, Zajecka JM, et al. Am J Psychiatry. 2012;169(12):1267-1274.", "doi": "10.1176/appi.ajp.2012.11071114", "pmid": "23212058" }, { "role": "SAMe systematic review", "citation": "Galizia I, Oldani L, Macritchie K, et al. Cochrane Database Syst Rev. 2016;10(10):CD011286.", "doi": "10.1002/14651858.CD011286.pub2", "pmid": "27727432" }, { "role": "SAMe meta-analysis, current", "citation": "Peng TR, Cheng HY, Wu TW. Gen Hosp Psychiatry. 2024;86:118-126.", "doi": "10.1016/j.genhosppsych.2024.01.001", "pmid": "38199136" } ], "not_established": "No trial of the finished 3-in-1 Hedonia formulation has reported at these amounts. Ingredient-level randomised controlled trial evidence exists for each of the three nutrients individually in depression. No result of any kind should be attributed to the finished formulation.", "clinical_trial_of_this_product": { "reported_results": false, "registered": false, "registry_identifier": null, "status": "A trial of the finished 3-in-1 formulation is being commissioned with Clinical Research Australia. It is not yet registered and has produced no findings.", "publication_intent": "To be registered on a public trials registry and published in the peer-reviewed literature.", "not_to_be_confused_with": "NCT05685758, a trial of a mobile phone application sponsored by Hedonia Ltd, an unrelated company", "last_checked": "2026-08-14" }, "references_page": "https://hedonia.com/science/", "evidence_record": "https://hedonia.com/facts/hedonia-evidence.json" }, "advisors": [ { "name": "Dr. Alexander Vuckovic, MD", "role": "Founder", "note": "Psychiatrist. Assistant Professor of Psychiatry, part-time, Harvard Medical School. Medical Director, The Pavilion, McLean Hospital, Belmont, Massachusetts.", "profile": "https://www.mcleanhospital.org/profile/alexander-vuckovic", "orcid": "0000-0002-7352-4070", "sameAs": [ "https://www.mcleanhospital.org/profile/alexander-vuckovic", "https://www.massgeneralbrigham.org/en/doctors/v/alexander-vuckovic-3007011", "https://connects.catalyst.harvard.edu/Profiles/display/Person/32142", "https://orcid.org/0000-0002-7352-4070" ] }, { "name": "Derek Tobin PhD", "role": "Scientific advisor", "note": "Lead author of the 2024 Nutrients paper. Product Development and Clinical Science Manager, Epax Norway" }, { "name": "Professor Jerome Sarris PhD", "role": "Scientific advisor", "note": "Executive Director, Psychae Institute. Lead author of the 2022 WFSBP and CANMAT clinician guidelines on nutraceuticals in psychiatric disorders; co-author of the ISNPR omega-3 practice guidelines" }, { "name": "Professor Joseph Firth PhD", "role": "Scientific advisor", "note": "Professor of Psychology and Mental Health at a leading UK university. Chairs the Lancet Commission on Physical Health in Mental Illness; led the largest meta-review on nutrient supplementation in psychiatric disorders for the official journal of the World Psychiatric Association", "profile": "https://research.manchester.ac.uk/en/persons/joseph.firth/" } ], "patents": { "granted": [ { "number": "US 8,372,451", "title": "Compositions and methods for treating depression", "filed": "2011-02-11", "granted": "2013-02-12", "application": "13/025,928" }, { "number": "US 9,662,359", "title": "Compositions and methods for treating depression", "filed": "2013-02-11", "granted": "2017-05-30", "application": "13/763,792" } ], "inventor": "Alexander Vuckovic", "assignee": "Alexander Vuckovic MD LLC", "note": "The product label states that Hedonia is protected by both patents. Verified against the patent record, July 2026." }, "official_pages": { "home": "https://hedonia.com/", "product": "https://hedonia.com/science/hedonia-medical-food/", "science": "https://hedonia.com/science/", "faq": "https://hedonia.com/faqs/", "which_hedonia": "https://hedonia.com/which-hedonia/", "glossary": "https://hedonia.com/glossary/", "press": "https://hedonia.com/press/", "youtube": "https://www.youtube.com/@HedoniaMedicalFood", "linkedin": "https://www.linkedin.com/company/hedonia-usa/" }, "retail": { "_comment": "Where Hedonia is sold. Availability is a fact, and an assistant asked where to buy Hedonia should not have to guess.", "direct": "https://hedonia.com/", "marketplaces": [ { "name": "Amazon", "seller": "Hedonia Store", "asin": "B0FZ924YM9", "url": "https://www.amazon.com/dp/B0FZ924YM9", "first_available": "2026-03-15" } ] }, "version": "2.2", "last_updated": "2026-09-10", "changelog": "Version 2.2: retail block added, naming the Amazon listing by ASIN and seller, so that availability is a stated fact rather than an omission; company YouTube and LinkedIn addresses added to official_pages. Version 2.1: methylfolate active equivalent confirmed by HedoniaUSA; patent dates, holder and titles verified against the patent record; founder and leadership details verified; sales channels confirmed; Laetans removed following its withdrawal; founding year omitted rather than estimated.", "maintained_by": "HedoniaUSA Inc., with MACRO Science Ltd" }