Submitted for Publication: December 16, 2014; final revision received February 13, 2015; accepted February 19, 2015.
Published Online: March 29, 2015. doi:10.1001/jamapsychiatry.2015.0241.
Study concept and design: Berwaerts, Liu, Gopal, Nuamah, Xu, Savitz, Coppola, Remmerie, Hough.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Berwaerts, Liu, Gopal, Nuamah, Xu, Hough.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Liu, Gopal, Nuamah, Xu.
Obtained funding: Gopal.
Administrative, technical, or material support: Berwaerts, Liu, Gopal, Savitz, Coppola, Schotte, Hough.
Study supervision: Gopal, Coppola, Hough.
Conflict of Interest Disclosures: Dr Maruta was the principal investigator for this study and has received research support and worked as a consultant for Janssen Research & Development, LLC. Drs Berwaerts, Gopal, Nuamah, Xu, Savitz, Coppola, Schotte, and Hough, Ms Liu, and Mr Remmerie are employees of Janssen Research & Development, LLC, which is a Johnson & Johnson company. No other disclosures were reported.
Funding/Support: This study was supported by Janssen Research & Development, LLC, Titusville, New Jersey.
Role of the Funder/Sponsor: Janssen Research & Development, LLC, had a role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, and approval of the manuscript; and decision to submit the manuscript for publication. An independent data monitoring committee convened by Janssen Research & Development, LLC, monitored the study.
Additional Contributions: Shalini Nair, PhD, SIRO Clinpharm Pvt Ltd, Maharashtra, India, provided writing assistance and Wendy P. Battisti, PhD, Janssen Research & Development, LLC, Titusville, New Jersey, provided additional editorial and writing support for the manuscript; they received compensation from the funding sponsor for these contributions. Navid Samad, MD, Samad Pharma and Biotech Consulting, LLC, White Plains, New York, contributed to data analysis; he received compensation as a paid consultant. Dean Najarian, PharmD, Janssen Pharmaceuticals, Titusville, contributed to medical monitoring; he received compensation as an employee of the sponsor. Christoph Correll, MD, Zucker Hillside Hospital, Glen Oaks, New York, L. Frederick Jarskog, MD, North Carolina Psychiatric Research Center, Raleigh, Mary F. Johnson, PhD, MJbiostat, Spring Lake, New Jersey, Joseph Peuskens, MD, PhD, Catholic University of Louvain, Kortenberg, Belgium, and Rene S. Kahn, MD, PhD, University Medical Center Utrecht, Utrecht, the Netherlands, were members of the independent data monitoring committee; they received a stipend from the contract research organization that administered the interim analysis. We thank the study participants, without whom this study would never have been accomplished, and the investigators for their participation in this study.