Submitted for Publication: January 13, 2014; final revision received May 4, 2014; accepted May 11, 2014.
Published Online: August 20, 2014. doi:10.1001/jamapsychiatry.2014.1054.
Study concept and design: Hollon, DeRubeis, Fawcett, Amsterdam, Shelton, Zajecka.
Acquisition, analysis, or interpretation of data: Hollon, DeRubeis, Fawcett, Amsterdam, Shelton, Young, Gallop.
Drafting of the manuscript: Hollon, DeRubeis, Amsterdam, Zajecka, Gallop.
Critical revision of the manuscript for important intellectual content: Hollon, DeRubeis, Fawcett, Amsterdam, Shelton, Zajecka, Young.
Statistical analysis: Hollon, DeRubeis, Zajecka, Gallop.
Obtained funding: Hollon, DeRubeis, Fawcett, Amsterdam, Shelton, Zajecka.
Administrative, technical, or material support: Hollon, DeRubeis, Fawcett, Amsterdam, Shelton, Zajecka, Young.
Study supervision: Hollon, DeRubeis, Fawcett, Amsterdam, Zajecka, Young.
Conflict of Interest Disclosures: Dr Shelton reports being a consultant to Bristol-Myers Squibb, Cerecor, Inc, Cyberonics, Inc, Forest Pharmaceuticals, Janssen Pharmaceutica, Medtronic, Inc, Naurex, Inc, Pamlab, Pfizer Inc, Ridge Diagnostics, Shire Plc, and Takeda Pharmaceuticals and receiving grant or research support from Assurex Health, Bristol-Myers Squibb, Elan Corp, Forest Pharmaceuticals, Janssen Pharmaceutica, Jazz Pharmaceuticals, Naurex, Inc, Novartis Pharmaceuticals, Otsuka Pharmaceuticals, Pamlab, and Takeda Pharmaceuticals. Dr Zajecka reports receiving grant or research support from Alkermes, Allergan, AstraZeneca, Cyberonics, Euthymics, ElMindA, Forest Pharmaceuticals, the Cheryl T. Herman Foundation, Hoffman-LaRoche, Naurex, Inc, Otsuka, the National Institutes of Health, Shire Plc, and Takeda Pharmaceuticals; serving as a consultant or on the advisory board of Abbvie, Avanir (Depression Data Safety Monitoring Board), Eli Lilly & Company, Forest Pharmaceuticals, Lundbeck, Pamlab, Shire Plc, and Takeda Pharmaceuticals; and receiving other financial support from the Cheryl T. Herman Foundation. No other disclosures were reported.
Funding/Support: This study was supported by grants MH60713 and MH01697 (K02) (Dr Hollon), MH60998 (Dr DeRubeis), and MH060768 (Drs Fawcett and Zajecka) from the National Institute of Mental Health. Wyeth Pharmaceuticals provided venlafaxine, and Pfizer Inc provided sertraline for the trial.
Role of the Funder/Sponsor: The funding sources 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.
Additional Information: Robert J. DeRubeis, PhD (University of Pennsylvania), Jan Fawcett, MD (University of New Mexico), and Steven D. Hollon, PhD (Vanderbilt University), were the principal investigators, and Jay D. Amsterdam, MD (University of Pennsylvania), John Zajecka, MD (Rush University), and Richard C. Shelton, MD (Vanderbilt University), were the coprincipal investigators. Drs DeRubeis and Hollon oversaw the implementation of CT at University of Pennsylvania and Vanderbilt University, respectively, and Dr Young did the same at Rush University. Dr Fawcett oversaw the implementation of pharmacotherapy across the study, and Drs Amsterdam, Zajecka, and Shelton supervised the implementation of pharmacotherapy at the respective sites.
Additional Contributions: Brent Freeman, BA, and Bernadette Kooi, MS (University of Pennsylvania), Debra Klbecka, RN, and Matthew Marasco, BA (Rush University), and Margaret L. Lovett, MEd (Vanderbilt University), served as the study coordinators. Giampaolo Gallo, MD, Moira Molloy, MSN, Bobbie Posmontier, PhD, Nancy Rutherford, MSN, Irene Soeller, CRNP, Jeffrey Staab, MD, and Jay D. Amsterdam, MD (University of Pennsylvania), Jagannath Devulapally, MD, Corey Goldstein, MD, Ian Mackey, MD, William Miles, MD, Raj Tummale, MD, and John Zajecka, MD (Rush University), and Virginia Gardner, MSN, Jennifer Scroggie, MSN, Sandra Seidel, MSN, and Vatsal Thakkar, MD (Vanderbilt University), served as study pharmacotherapists. Julie Jacobs, PhD, Cory P. Newman, PhD, and Rita Ryan, PhD (University of Pennsylvania), David C. Clark, PhD, Kristen Flynn, PhD, John Larson, MD, Patricia Meaden, PhD, Chad Owen, PsyD, and Paula R. Young, PhD (Rush University), and Laurel L. Brown, PhD, Kirsten Haman, PhD, Karl N. Jannasch, PhD, Sandra Seidel, MSN, and Dorothy D. Tucker, PhD (Vanderbilt University), served as the cognitive therapists. Kirsten L. Haman, PhD, oversaw the training of the clinical interviewers. All of the above were reimbursed for their participation. William T. McKinney, MD (Northwestern University [emeritus]), Irene Elkin, PhD (University of Chicago [emerita]), Robert Gibbons, PhD, and Mark Siegler, MD (University of Chicago), and Burt Jensen (Federal Bureau of Investigation [retired]) served on the independent data safety monitoring board. Members of the board received an honorarium for their participation. DatStat developed the data entry and patient management system used to conduct the study.