Submitted for Publication: August 30, 2013; final revision received January 24, 2014; accepted January 24, 2014.
Published Online: April 2, 2014. doi:10.1001/jamapsychiatry.2014.163.
Study concept and design: Alberati, Martin-Facklam, Borroni, Knoflach, Dorflinger, Wettstein, Garibaldi, Santarelli.
Acquisition, analysis, or interpretation of data: Umbricht, Martin-Facklam, Borroni, Youssef, Ostland, Wallace, Bausch, Santarelli.
Drafting of the manuscript: Umbricht, Wallace, Knoflach, Wettstein, Garibaldi, Santarelli.
Critical revision of the manuscript for important intellectual content: Alberati, Martin-Facklam, Borroni, Youssef, Ostland, Dorflinger, Bausch, Garibaldi, Santarelli.
Statistical analysis: Ostland.
Administrative, technical, or material support: Youssef, Wallace, Dorflinger, Garibaldi.
Study supervision: Umbricht, Borroni, Youssef, Bausch.
Conflict of Interest Disclosures: Drs Umbricht, Alberati, Martin-Facklam, Borroni, Youssef, Ostland, Knoflach, Dorflinger, Wettstein, Garibaldi, and Santarelli are employees of F. Hoffmann–La Roche Ltd. Dr Wallace was an employee of F. Hoffmann–La Roche Ltd during the conduct of the experiments in nonhuman primates. Dr Bausch was an employee of F. Hoffmann–La Roche Ltd during the conduct of the proof-of-concept study.
Funding/Support: This study was sponsored by F. Hoffman–La Roche Ltd.
Role of the Sponsor: F. Hoffmann–La Roche Ltd had a 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.
Additional Contributions: We thank Donald Goff, MD (Department of Psychiatry, New York University, New York), and Marc Laruelle, MD, PhD (Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut), for valuable comments on earlier versions of this manuscript. They did not receive compensation for their contributions. We also thank the investigators of the phase 2 study for recruiting and assessing patients: Csaba Almasi, Aleksander Araszkiewicz, Alla Avedisova, Istvæn Bitter, Przemyslaw Bogacki, Rodrigo Bressan, David Brown, Miranda Chakos, Læszl Csekey, Marek Cwiakala, Daniel Dassa, Natalia Dobrovolskaya, Helio Elkis, Tetsuro Enomoto, Donald Garcia, Hamilton Grabowski, Andrey Gribanov, Jun Ishigooka, Nakao Iwata, Mieczyslaw Janiszewski, Lala Kasimova, Hiroaki Kawasaki, Mary Knesevich, Sændor Koffler, Alex Kopelowicz, Alexsander Kotsubinsky, Jelena Kunovac, Tamas Kurimay, Toshihide Kuroki, Ichiro Kusumi, Mark Lerman, Andreas Mahler, Margarita Morozova, Joaquim Mota Neto, Tadashi Murakami, Judit Nagy, Henry Nasrallah, Nikolay Neznanov, Claus Normann, Mark Novitsky, Youtaro Numachi, Toshinari Odawara, Tetsuro Ohmori, Irismar Reis de Oliveira, Alfonso Ontiveros, György Ostorharics-Horvæth, Hiroki Ozawa, Høctor Pinedo, Philippe Raymondet, Robert Reisenberg, Sandra Ruschel, Margot Schmitz, Gunther Schumann, Kazumasa Shiozaki, Rajinder Shiwach, George Simpson, Joachim Springub, Klaus Steinwachs, Jaroslaw Strzelec, Louise Thurman, Gabor Vincze, David Walling, Ryszard Wardenski, Kauser Yakhin, Reiji Yoshimura, and Marcel Zins-Ritter. All investigators were compensated for their work according to the contracts made for their participation in the study. Editorial assistance for this manuscript was provided by ApotheCom and Archimed Medical Communication AG, Switzerland.