St John's Wort (Hypericum perforatum) versus Sertraline and Placebo in Major Depressive Disorder: Continuation Data from a 26-Week RCT
J Sarris, M Fava, I Schweitzer, D Mischoulon
PHARMACOPSYCHIATRY | GEORG THIEME VERLAG KG | Published : 2012
Hypericum perforatum (St John's wort: SJW) has been extensively studied as an antidepressant in short-term trials, however little research has been conducted on longer-term efficacy.Our objective was to analyze the continuation data from a 26-week randomized, double-blind, controlled study of SJW (LI-160) vs. sertraline and placebo in major depressive disorder. 124 participant "responders" continued treatment after week 8, until week 26. They continued randomly assigned SJW (900-1 500 mg), sertraline (50-100 mg) or matching placebo.At week 26, on the primary outcome, Hamilton depression rating scale (HAM-D) completer scores were: SJW (6.6±4.5), sertraline (7.1±5.4) and placebo (5.7±5.4) with..View full abstract
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Awarded by Australian National Health & Medical Research Council fellowship (NHMRC)
Awarded by NATIONAL INSTITUTE OF MENTAL HEALTH
This reanalysis is supported in part by the MGH Depression Clinical and Research Program's clinical practice revenues. The authors thank the members of the Hypericum Depression Trial Study Group for allowing us access to the original database from their clinical trial. Information about the database and how to obtain access to it is available at: http://www.nimh.nih.gov/trials/datasets/nimh-procedures-for-requesting-data-sets.shtml. The grant number of the parent study is N01 MH070007. The ClinicalTrials.gov Identifier is NCT00005013. The Placebo-Controlled Clinical Trial of a Standardized Extract of Hypericum perforatum in Major Depressive Disorder was conducted and supported by the National Institute of Mental Health (NIMH) and the National Center for Complementary and Alternative Medicine (NCCAM) in collaboration with the study investigators. This manuscript reflects the views of the authors and may not reflect the opinions or views of all the study investigators, the NIMH, or the NCCAM. Study medications were donated by Lichtwer Pharma and Pfizer. Dr. Jerome Sarris is funded by an Australian National Health & Medical Research Council fellowship (NHMRC funding ID 628875), in a strategic partnership with The University of Melbourne and The Centre for Human Psychopharmacology at Swinburne University of Technology.No direct conflicts of interest noted. Dr. Sarris is involved in academic research of natural products in the treatment of psychiatric disorders. This publication is not supported by any direct funding and no potential financial benefit is expected as a result of this publication. Dr. Sarris has received travel grant funding from Integria Health, Society for Medicinal Plant and Natural Product Research, and Pfizer. Dr. Fava has received research support from: Alkermes, Inc.; AstraZeneca; BioResearch; BrainCells Inc.; Bristol-Myers Squibb; CeNeRx BioPharma; Clinical Trials Solutions, LLC; Clintara, LLC; Covance; Covidien; Eli Lilly and Company; EnVivo Pharmaceuticals, Inc.; Euthymics Bioscience, Inc.; Forest Pharmaceuticals, Inc.; Ganeden Biotech, Inc.; GlaxoSmithKline; Icon Clinical Research; i3 Innovus/Ingenix; Johnson & Johnson Pharmaceutical Research & Development; National Alliance for Research on Schizophrenia & Depression (NARSAD); National Center for Complementary and Alternative Medicine (NCCAM); National Institute of Drug Abuse (NIDA); National Institute of Mental Health (NIMH); Novartis AG; PamLab, LLC.; Pfizer Inc.; Pharmavite (R) LLC; Photothera; Roche Pharmaceuticals; RCT Logic, LLC; Sanofi-Aventis US LLC; Synthelabo; Wyeth-Ayerst Laboratories. He has served as Advisor/Consultant to: Abbott Laboratories; Affectis Pharmaceuticals AG; Alkermes, Inc.; Amarin Pharma Inc.; Aspect Medical Systems; AstraZeneca; Auspex Pharmaceuticals; Bayer AG; Best Practice Project Management, Inc.; BioMarin Pharmaceuticals, Inc.; Biovail Corporation; BrainCells Inc; Bristol-Myers Squibb; CeNeRx BioPharma; Cephalon, Inc.; Clinical Trials Solutions, LLC; CNS Response, Inc.; Compellis Pharmaceuticals; Cypress Pharmaceutical, Inc.; DiagnoSearch Life Sciences (P) Ltd.; Dinippon Sumitomo Pharma Co. Inc.; Dov Pharmaceuticals, Inc.; Edgemont Pharmaceuticals, Inc.; Eisai Inc.; Eli Lilly and Company; ePharmaSolutions; EPIX Pharmaceuticals, Inc.; Euthymics Bioscience, Inc.; Fabre-Kramer Pharmaceuticals, Inc.; Forest Pharmaceuticals, Inc.; GenOmind, LLC; GlaxoSmithKline; Grunenthal GmbH; i3 Innovus/Ingenis; Janssen Pharmaceutica; Jazz Pharmaceuticals, Inc.; Johnson & Johnson Pharmaceutical Research & Development, LLC; Knoll Pharmaceuticals Corp.; Labopharm Inc.; Lorex Pharmaceuticals; Lundbeck Inc.; MedAvante, Inc.; Merck & Co., Inc.; MSI Methylation Sciences, Inc.; Naurex, Inc.; Neuronetics, Inc.; Next Wave Pharmaceuticals; Novartis AG; Nutrition 21; Orexigen Therapeutics, Inc.; Organon Pharmaceuticals; Otsuka Pharmaceuticals; Pam Lab, LLC.; Pfizer Inc.; PharmaStar; Pharmavite LLC.; PharmoRx Therapeutics; Precision Human Biolaboratory; Prexa Pharmaceuticals, Inc.; Puretech Ventures; PsychoGenics; Psylin Neurosciences, Inc.; Rexahn Pharmaceuticals, Inc.; Ridge Diagnostics, Inc.; Roche; RCT Logic, LLC; Sanofi-Aventis US LLC.; Sepracor Inc.; Servier Laboratories; Schering-Plough Corporation; Solvay Pharmaceuticals, Inc.; Somaxon Pharmaceuticals, Inc.; Somerset Pharmaceuticals, Inc.; Sunovion Pharmaceuticals; Supernus Pharmaceuticals, Inc.; Synthelabo; Takeda Pharmaceutical Company Limited; Tal Medical, Inc.; Tetragenex Pharmaceuticals, Inc.; Trans Form Pharmaceuticals, Inc.; Transcept Pharmaceuticals, Inc.; Vanda Pharmaceuticals, Inc.; Wyeth-Ayerst Laboratories He has received speaking and publishing honoraria from: Adamed, Co; Advanced Meeting Partners; American Psychiatric Association; American Society of Clinical Psychopharmacology; AstraZeneca; Belvoir Media Group; Boehringer Ingelheim GmbH; Bristol-Myers Squibb; Cephalon, Inc.; CME Institute/Physicians Postgraduate Press, Inc.; Eli Lilly and Company; Forest Pharmaceuticals, Inc.; GlaxoSmithKline; Imedex, LLC; MGH Psychiatry Academy/Primedia; MGH Psychiatry Academy/Reed Elsevier; Novartis AG; Organon Pharmaceuticals; Pfizer Inc.; PharmaStar; United BioSource, Corp.; Wyeth-Ayerst Laboratories; Equity Holdings: Compellis. Royalty/patent, other income: Patent for Sequential Parallel Comparison Design (SPCD) and patent application for a combination of azapirones and bupropion in Major Depressive Disorder (MDD), copyright royalties for the MGH Cognitive & Physical Functioning Questionnaire (CPFQ), Sexual Functioning Inventory (SFI), Antidepressant Treatment Response Questionnaire (ATRQ), Discontinuation-Emergent Signs & Symptoms (DESS), and SAFER. Patent for research and licensing of SPCD with RCT Logic; Lippincott, Williams & Wilkins; World Scientific Publishing Co. Pte. Ltd. Dr Schweitzer has received speaking honoraria from AstraZeneca, Eli Lilly, Lundbeck, Wyeth, Pfizer, Servier, and Janssen-Cilag; consultancy fees from AstraZeneca, Eli Lilly, Lundbeck, Wyeth, and Pfizer; and educational or research grants, sponsorships, or donations from Wyeth, Lundbeck, and Bristol-Myers Squibb. Dr. Mischoulon has received research support from Nordic Naturals, Ganeden, Fisher Wallace, and the Bowman Family Foundation. He has served as an advisor/consultant to Bristol-Meyers Squibb Company, and ICON. He has received speaking honoraria from Nordic Naturals, and writing honoraria from Pam lab. He has received royalties from Back Bay Scientific for PMS Escape, and from Lippincott Williams & Wilkins for textbook "Natural Medications for Psychiatric Disorders: Considering the Alternatives" (David Mischoulon and Jerrold F Rosenbaum, Eds.). He has received honoraria from Reed Medical Education (a company working as a logistics collaborator for the MGH Psychiatry Academy). The education programs conducted by the MGH Psychiatry Academy were supported through Independent Medical Education (IME) grants from pharmaceutical companies co-supporting programs along with participant tuition. Commercial entities currently supporting the MGH Psychiatry Academy are listed on the Academy's website www.mghcme.org. No payment from any individual entity or company has exceeded0000/year.