Submitted for Publication: October 29, 2013; final revision received June 1, 2014; accepted June 9, 2014.
Published Online: October 8, 2014. doi:10.1001/jamapsychiatry.2014.1314.
Study concept and design: Correll, D. G. Robinson, Schooler, Brunette, Mueser, Rosenheck, Marcy, Addington, Penn, Heinssen, Kane.
Acquisition, analysis, or interpretation of data: Correll, D. G. Robinson, Schooler, Brunette, Marcy, Estroff, J. Robinson, Azrin, Goldstein, Severe.
Drafting of the manuscript: Correll, D. G. Robinson, Rosenheck.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Correll.
Obtained funding: Correll, D. G. Robinson, Brunette, Mueser, Estroff, Azrin, Heinssen, Kane.
Administrative, technical, or material support: D. G. Robinson, Schooler, Brunette, Marcy, J. Robinson, Penn, Severe.
Study supervision: Kane.
Conflict of Interest Disclosures: Dr Correll has been a consultant and/or advisor to or has received honoraria from Actelion, Alexza, American Academy of Child and Adolescent Psychiatry, Bristol-Myers Squibb, Cephalon, Eli Lilly and Co, Genentech, Gerson Lehrman Group, IntraCellular Therapies, Lundbeck, Medavante, Medscape, Merck, National Institute of Mental Health, Janssen/Johnson & Johnson, Otsuka, Pfizer, ProPhase, Roche, Sunovion, Takeda, Teva, and Vanda and has received grant support from Bristol-Myers Squibb, Feinstein Institute for Medical Research, Janssen/Johnson & Johnson, National Institute of Mental Health, National Alliance for Research in Schizophrenia and Depression, Novo Nordisk A/S, and Otsuka. Dr D. G. Robinson has been a consultant to Asubio and Shire and has received grants from Bristol-Myers Squibb, Janssen, and Otsuka. Dr Schooler has been a consultant to Abbott, Amgen, Eli Lilly and Co, Janssen Psychiatry, Lundbeck, Merck, Nupathe, Pfizer, and Shire and has received grants from AstraZeneca, Bristol-Myers Squibb, Eli Lilly, H. Lundbeck, Ortho-McNeil-Janssen, Neurocrine, Otsuka, and Pfizer. Dr Rosenheck has received research support from Janssen Pharmaceutica and Wyeth Pharmaceuticals; has been a consultant to Otsuka; and has provided expert testimony. Dr Addington has served as a consultant to Roche. Dr Kane has been a consultant and/or advisor to or has received honoraria from Alkermes, Amgen, Bristol-Myers Squibb, Eli Lilly and Co, Esai, Forest Laboratories, Genentech, Gerson Lehrman Group, IntraCellular Therapies, Janssen, Jazz, Johnson & Johnson, Lundbeck, MedAvante, Merck, Novartis, Otsuka, Pierre Fabre, Proteus, Pfizer, Roche, Reviva, Sunovion, Takeda, Targacept, and Vanda and is a shareholder of MedAvante. No other disclosures were reported.
Funding/Support: This work was supported in part by grant HHSN-271-2009-00019C from the National Institute of Mental Health (Dr Kane) and by federal funds from the American Recovery and Reinvestment Act.
Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Previous Presentation: This paper was presented in part at the 52nd Annual Meeting of the New Clinical Drug Evaluation Unit; May 30, 2013; Hollywood, Florida.
Additional Contributions: We thank the participating patients and their families, each of the participating 34 centers, and their personnel.