Author Contributions: Ms Jones 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: Krystal, Rosenheck, Cramer, Jones, Vertrees.
Acquisition of data: Rosenheck, Cramer, Vessicchio, Stock.
Analysis and interpretation of data: Krystal, Rosenheck, Jones, Vertrees, Horney, Huang.
Drafting of the manuscript: Krystal, Rosenheck, Huang.
Critical revision of the manuscript for important intellectual content: Krystal, Rosenheck, Cramer, Vessicchio, Jones, Vertrees, Horney, Huang, Stock.
Statistical analysis: Krystal, Rosenheck, Jones, Horney.
Obtained funding: Krystal, Vertrees, Huang.
Administrative, technical, or material support: Cramer, Vessicchio, Jones, Vertrees, Huang, Stock.
Study supervision: Krystal, Vertrees, Huang.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Krystal reported having received research support from Janssen Research Foundation; having been a consultant to Aisling Capital, AstraZeneca, Brintnall and Nicolini, Bristol-Myers Squibb, Easton and Associates, Eli Lilly, F. Hoffman LaRoche, Forest Laboratories, Gilead Sciences, GlaxoSmithKline, Janssen, Lundbeck Research USA, Medivation, Merz Pharmaceuticals, MK Medical Communications, Naurex, Pfizer, SK Holdings, Sunovion Pharmaceuticals, Takeda Industries, Tetragenex, and Teva Pharmaceutical Industries; having patents for glutamatergic treatment of neuropsychiatric disorders and intranasal administration of ketamine to treat depression (pending); having served on the scientific advisory boards for Abbott, Bristol-Myers Squibb, Eisai, Eli Lilly, Forest Laboratories, Lohocla Research Corporation, Mnemosyne Pharmaceuticals, Naurex, Pfizer, and Shire; and being the editor of Biological Psychiatry and president elect of the American College of Neuropsychopharmacology. Dr Rosenheck reported having received research support from Eli Lilly, Janssen Pharmaceutica, Astra-Zeneca, and Wyeth Pharmaceuticals; having been a consultant to GlaxoSmithKline, Bristol-Myers Squibb, Organon, Janssen Pharmaceutica, and Otsuka; having provided expert testimony for the plaintiffs in UFCW Local 1776 and Participating Employers Health and Welfare Fund, et al v Eli Lilly and Company ; for the respondent in Eli Lilly Canada Inc v Novapharm Ltd and Minister of Health respondent ; and for the Patent Medicine Prices Review Board of Canada in the matter of Janssen Ortho Inc and “Risperdal Consta”; and being a testifying expert in Jones ex rel the State of Texas v Janssen Pharmaceutica et al. No other conflicts were reported.
Funding/Support: This study was supported by the Cooperative Studies Program of the Department of Veterans Affairs Office of Research and Development. Risperidone and matching placebo were donated to the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center (Albuquerque, New Mexico) by Ortho-McNeil Janssen Scientific Affairs. Ortho-McNeil Janssen Scientific Affairs also contributed a total of $606 219 to the Baltimore Research and Education Foundation on behalf of the VA Cooperative Studies Program.
Role of the Sponsors: The authors were responsible for the collection, management, and analysis of the data and for the preparation of the manuscript and its submission for publication. The funding sources did not have a role in the collection, management, or analysis of the data. The funding sources were provided with a draft of the paper, and they were invited to provide input on the text. Representatives of Ortho-McNeil Janssen Scientific Affairs attended 2 meetings where the design of the study was discussed. Ortho-McNeil Janssen Scientific Affairs was not responsible for and did not determine the final design of the study, did not collect or manage study data, did not draft the manuscript, and did not have approval authority over the content of the paper.
Members of the Department of Veterans Affairs Cooperative Study No. 504 Group (in addition to the authors): J. Canive, L. Calais, A. Smith, E. Nye, Albuquerque, New Mexico; E. Duncan, K. Skelton, R. Bradley, K. Tabb, T. Sergent, M. Daugherty, E. Russ, Atlanta, Georgia; N. Denny, K. Arnemann, J. Lauren-Rusnack, J. Schillac, Austin, Texas; S. Batten, L. Dixon, A. Santanello, L. Bell, J. Duncan, S. Carney, G. Kavanagh, Baltimore, Maryland; P. Parker, K. McCall, S. Rathmell, Birmingham, Alabama; D. Kaloupek, G. Aguayo, D. Ryngala, A. Collins, Boston, Massachusetts; M. Hamner, D. Agbor-Tabi, M. Timmerman, M. Brown, S. Robert, S. Coleman, Charleston, South Carolina; P. Fore, T. Tepper, J. Yount, Chicago, Illinois; E. Konicki, V. Nero, E. Smith, R. Huhra-Grassel, Cleveland, Ohio; A. Suris, C. North, J. Whitman, E. Wiley, Dallas, Texas; M. Hertzberg, R. Biddix, M. Becker, Durham, North Carolina; T. Grieder, C. Feigel, East Los Angeles, California; T. Vo, P. Wolf, Fargo, North Dakota; R. Garza, C. Murphy, B. Melton, Houston, Texas; E. Ahearn, C. Johnson, M. Mussey, T. Smith, Madison, Wisconsin; D. David, J. Junco-Valladares, P. Slone, A. Giron, Miami, Florida; J. Westermeyer, M. Spring, A. Ferrier, Minneapolis, Minnesota; M. Eakin, A. Wolkin, C. Woo, M. Kramer, New York, New York; R. Erhman, K. Marquez, A. Fornish, Philadelphia, Pennsylvania; A. Khan, A. Zakai, H. Frank, J. Kikuchi, Providence, Rhode Island; C. Stock, L. Carpenter, S. Plumb, S. Allen, C. Olsen, M. Greenwell, Salt Lake City, Utah; J. Casada, J. Polanco, T. Benson, San Antonio, Texas; D. Baker, P. Shah, P. Gorman, T. Perin, A. Kelada, J. Cooley, J. Pittman, N. Madra, San Diego, California; F. Schoenfeld, M. Schmitz, R. Coeshott, H. Q. Tong, San Francisco, California; L. Davis, C. Garner, J. Newell, Tuscaloosa, Alabama; P. Hicks, S. Justice, B. Lippe, Waco, Texas; C. S. Saunders, D. Goldstein, S. Ereshefsky, A. Melnick, M. Urbaitis, West Los Angeles, California; S. Affleck, M. Beam, E. Spence, D. Briones, S. Dixon, C. Howell, X. Lu, Perry Point, Maryland; D. Conner, C. Haakenson, Albuquerque. Data Monitoring Committee: T. Grieger, Falls Church, VA; D. Blake, Boise, ID; K. Dickerson, Baltimore; M. Thase, Philadelphia; P. Harvey, Miami. Executive Committee: K. Jones, Perry Point; J. Vertrees, Albuquerque; M. Stein, San Diego; C. Stock, Salt Lake City; M. Hertzberg, Durham; E. Duncan, Atlanta; J. Gelernter, New Haven, Connecticut. Planning Committee: D. Ciraulo, D. Kaloupek, Boston; M. Stein, San Diego; G. Bartzokis, Los Angeles; A. Rasmusson, West Haven, Connecticut; J. Davidson, Durham; C. Marmar, San Francisco; P. Lavori, Menlo Park, California; S. Berkowitz, T. O’Leary, B. Schuster, Washington, DC; K. Jones, J. Collins, C. Howell, Perry Point; J. Vertrees, Albuquerque; D. Bradham, Baltimore; M. Friedman, White River Junction, Vermont.
Additional Contributions: We thank Frank Weathers, PhD, Department of Psychology, Auburn University, for providing CAPS training and rater certification. He did receive compensation for this contribution.