Author Contributions: Dr Carney had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Carney, Freedland, Rubin, Rich.
Acquisition of data: Carney, Freedland, Rubin, Harris.
Analysis and interpretation of data: Carney, Freedland, Rubin, Rich, Steinmeyer, Harris.
Drafting of the manuscript: Carney, Freedland, Steinmeyer, Harris.
Critical revision of the manuscript for important intellectual content: Carney, Freedland, Rubin, Rich.
Statistical analysis: Freedland, Steinmeyer.
Obtained funding: Carney, Freedland.
Administrative, technical, or material support: Carney, Rubin.
Study supervision: Carney, Rubin.
Financial Disclosures: Dr Carney reports that he has received an honorarium from Forest Laboratories Inc for participating in a symposium and completing a review of the literature concerning depression and heart disease. He or a member of his family is a stockholder in Pfizer Inc, Forest Laboratories, and Johnson and Johnson Inc. Dr Harris reports that he is a scientific advisor to Glaxo-Smith-Kline, Monsanto, Unilever and OmegaQuant Analytics; is a speaker for Glaxo-Smith-Kline and OmegaQuant Analytics; and is a stockholder in OmegaQuant Analytics. No other disclosures were reported.
Funding/Support: This study was supported by grant RO1 HL076808-01A1 from the National Heart, Lung, and Blood Institute. GlaxoSmithKline Inc supplied omega-3 and placebo capsules and Pfizer Inc supplied sertraline.
Role of the Sponsor: The peer review process of the National Institutes of Health resulted in some changes in the original design of the study prior to funding. The National Institutes of Health had no further role in study design and no role in data collection, data analysis, data interpretation, or writing of the manuscript. Glaxo-Smith-Kline Inc and Pfizer Inc had no role in study design, data collection, data analysis, data interpretation, or writing of the manuscript. Dr Carney had final responsibility for the decision to submit the manuscript for publication after funding.
Additional Contributions: We thank Ronald Krone, MD, for his service on the data and safety monitoring committee and Judith Skala, PhD, Stephanie Porto, PharmD, Julie Nobbe, PharmD, Patricia Herzing, RN, Cathi Klinger, RN, Carol Sparks, LPN, Tiffany Bonds, and Kim Metze (Washington University, St Louis, Missouri) for their contributions to the conduct of the trial. We also thank Nancy Frasure-Smith, PhD, and Francois Lespérance, MD (University of Montreal, Montreal, Quebec, Canada) for providing valuable advice during the planning of the study. Drs Frasure-Smith and Lespérance received payment for consultation services.