Copyright 2016 American Medical Association. All Rights Reserved.
To the Editor We write to report that we have discovered a number of pervasive errors in our published trial comparing recovery rates for major depressive disorder with cognitive therapy and medication vs medication alone (Effect of Cognitive Therapy With Antidepressant Medications vs Antidepressants Alone on the Rate of Recovery in Major Depressive Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2014;71(10):1157-1164).1
These errors, once corrected, have not changed the final conclusion of this study—that cognitive therapy combined with antidepressant medication treatment enhanced rates of recovery relative to treatment with medication alone. However, the corrections do result in changes to numerous data in the Abstract, text, Table, and Figures. Three of the findings that were previously reported as statistically significantly different are no longer significantly different: the interaction between recovery rate and severity, the number of patients who dropped out of each group, and the number of serious adverse events in each group. Because of these errors, we have reconducted our analyses with the correct data, have corrected all findings and interpretations, and have requested that JAMA Psychiatry retract and replace the original article.
The major problem with our original reported data was that the automated algorithm that we used to track patient progress sometimes failed to recognize remissions or recoveries that occurred or it recognized only later instances. This resulted in missing recoveries in 13 patients. There were 5 additional patients who recovered in the combined treatment group (the correct number is 170 not 165), and 8 additional patients who recovered in the medications only group (the correct number is 148 not 140). In addition, 282 patients recovered earlier and 16 patients recovered later than was initially recognized in our analyses. Differences between the treatment conditions were largely unaffected but the median time to recovery was reduced. In the process of hand-checking our data, we also found 2 patients who were credited with remissions that they did not achieve (1 in each group). Correcting these errors affected the cell sizes reported in Figures 2 and 3 and the exact values of the tests reported and also resulted in a change in the interaction between severity and treatment condition, which is no longer a statistically significant interaction.
There were other errors that led us to conduct an intensive review of the data. In one instance, a single patient was misclassified as having low-severity major depressive disorder at intake when he actually had high-severity major depressive disorder. This resulted from the use of a Hamilton Rating Scale for Depression score from this patient’s initial screening assessment rather than from the later assessment that led to inclusion in the trial. The earlier lower score was inadvertently used as a covariate in the primary analyses. Correcting this error did not alter any of the statistical inferences drawn or the study conclusions, but it did affect (by 1) the cell sizes reported in Figures 2 and 3 and the exact values of the tests reported (usually only at the level of the second decimal place). The correct values were reported in the original Table.
In addition, in the original Table, the number of patients who met criteria for chronic depression was undercounted by 13 and the number who met criteria for recurrent depression was undercounted by 5. The correct values are 172 of 452 (38.1%) with chronic depression and 381 (84.3%) with recurrent depression. In each instance, the evaluator had neglected to check the box for chronic or recurrent depression when entering the patient information into our automated data entry system but did record the length and number of the episode correctly. Given that we used episode length and number in our computations, underreporting the number of patients with chronic and recurrent depression in the Table did not affect any of the statistical analyses.
Also, in the original Table, we misreported numbers of patients for 3 other characteristics: those unemployed, with prior use of antidepressants, and with other Axis I disorders. We had overreported the number of patients who were unemployed as 140 (31%) but the correct number is 65 (14.4%). We had underreported the number of patients exposed to prior antidepressant medications by inadvertently excluding several types of antidepressants. We had reported 303 (67.0%) with prior use of antidepressants, but the correct number is 395 (87.4%). The reported numbers of patients comorbid with other Axis I disorders were undercounted by 2. We had reported 226 (50%), but the correct number is 228 (50.4%). None of those errors affected any of the analyses or the inferences in the published article.
We apologize to the journal and its readers for the errors that were present in our original publication, and we appreciate the action taken by the reader who alerted us to the undercounts in the Table just described that prompted our complete review of the data, analyses, and conclusions. The relevant data and findings have now been corrected, and the Abstract, text, Table, and Figures 1, 2, and 3 in our article have been corrected and replaced online with a new supplement that includes a version of the original retracted article showing the original errors and a version of the replacement article showing what was corrected.
Corresponding Author: Steven D. Hollon, PhD, Department of Psychology, Vanderbilt University, 306 Wilson Hall, Nashville, TN 37203 (email@example.com).
Published Online: April 20, 2016. doi:10.1001/jamapsychiatry.2016.0756
Conflict of Interest Disclosures: At the time of publication, Dr Shelton reported 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 reported 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.
Hollon SD, DeRubeis RJ, Fawcett J, Amsterdam JD, Shelton RC, Zajecka J, Young PR, Gallop R. Notice of Retraction and Replacement. Hollon et al. Effect of cognitive therapy with antidepressant medications vs antidepressants alone on the rate of recovery in major depressive disorder: a randomized clinical trial. JAMA Psychiatry. 2014;71(10):1157-1164. JAMA Psychiatry. 2016;73(6):639-640. doi:10.1001/jamapsychiatry.2016.0756