Study concept and design: McEvoy, Byerly, Hamer, Swartz, Rosenheck, Stroup.
Acquisition, analysis, or interpretation of data: McEvoy, Byerly, Hamer, Dominik, Swartz, Rosenheck, Ray, Buckley, Lamberti, Wilkins, Stroup.
Drafting of the manuscript: McEvoy, Byerly, Hamer, Dominik, Swartz, Stroup.
Critical revision of the manuscript for important intellectual content: McEvoy, Byerly, Hamer, Dominik, Swartz, Rosenheck, Ray, Buckley, Lamberti, Wilkins, Stroup.
Statistical analysis: Hamer, Dominik, Ray, Wilkins.
Obtained funding: McEvoy, Byerly, Hamer, Swartz, Stroup.
Administrative, technical, or material support: McEvoy, Swartz, Rosenheck, Stroup.
Study supervision: McEvoy, Hamer, Dominik, Swartz, Wilkins, Stroup.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Drs McEvoy, Byerly, Hamer, and Stroup report receipt of a grant from the National Institute of Mental Health (NIMH). Dr McEvoy reports receipt of a grant from Merck, Sunovion, Roche/Genentech, GlaxoSmithKline (outside submitted work), and Psychogenics (outside submitted work); and personal fees (speaking honoraria) from Lilly, Merck, and Sunovion; and personal fees for consulting from Otsuka, Roche/Genentech, Envivo, and Alkermes. Dr Byerly reports receipt of research support from Otsuka; a grant from Sunovion (outside the submitted work); and personal fees from Janssen, Merck, Novartis, Otsuka, and Bristol-Myers Squibb. Dr Hamer reports receipt of personal fees (data safety and monitoring board) from Novartis, Roche, Protein Sciences, Alkermes, Allergan, Abbot/Abvie, Bioline, and Columbia University, (clinical trials consulting) from Lilly, AstraZeneca, Duke University,Cenerx, and National University of Singapore/Duke, (expert witness) from Winston and Strawn, Sheppard Mullin, Rakoczy Molino Mazzochi Siwik, and Goldberg Segalla, (grant review panel) from Veterans Administration, and (mock advisory panel) from Titan, and Neurogex outside the submitted work. Dr Swartz reports receipt of personal fees for consulting from Med-IQ outside the submitted work. Dr Rosenheck reports receipt of personal fees (expert witness) in Jones ex rel the State of Attorney Genera of Texas in Texas v Janssen Phamaceutica et al, and (consultant) from Otsuka outside the submitted work. Dr Buckley reports receipt of grants and personal fees (DSMB and federal reviews) from NIMH, and grants from Ameritox and Posit Science outside the submitted work. Dr Stroup reports participation in CME activities funded by Genentech outside the submitted work. Drs Dominik and Lamberti and Mss Ray and Wilkins report no disclosures.
The following investigators conducted the study: Lawrence Adler, Glen Burnie, MD; Peter Buckley, Augusta, GA; Matthew Byerly, Dallas, TX; Stanley Caroff, Philadelphia, PA; Cherilyn DeSouza, Kansas City, MO; Dale D’Mello, Lansing, MI; Deepak D’Souza, New Haven, CT; Fred Jarskog, Chapel Hill, NC; Venkata Jasty, Detroit, MI; Eric Konicki, Cleveland, OH; Matthew Macaluso, Wichita, KS; J. Steven Lamberti, Rochester, NY; Joshua Kantrowitz, New York, NY; Joseph McEvoy, Butner, NC; Del Miller, Iowa City, IA; Robert Millet, Durham, NC; Max Schubert, Waco, TX; Martin Strassnig, Miami, FL; Sriram Ramaswamy, Omaha, NE; Andre Tapp, Tacoma, WA; Sarah Yasmin, Palo Alto, CA.
Funding/Support: The study was funded by grants from NIMH to Drs McEvoy and Stroup.
Role of the Sponsors: NIMH had no role in the design and conduct of the study, in the collection, analysis, and interpretation of the data, and in the preparation, review, or approval of the manuscript. The funder had no role in the decision to submit the manuscript for publication. A DSMB convened by NIMH monitored the study. NIMH grant funds paid for all study medications.
Additional Contributions: The authors thank Adam Haim, PhD, and Joanne Severe, MS, of NIMH for their support during the project. Neither individual received additional compensation in association with work on this article.
Correction: This article was corrected on May 20, 2014, to fix a denominator in the Secondary Outcomes section, and corrected on July 3, 2014, to fix a typographical error.