Original Article
Neuropsychopharmacology (2005) 30, 405–416, advance online publication, 1 December 2004; doi:10.1038/sj.npp.1300614
Clinical Research
Self-Reported Depressive Symptom Measures: Sensitivity to Detecting Change in a Randomized, Controlled Trial of Chronically Depressed, Nonpsychotic Outpatients
A John Rush1, Madhukar H Trivedi1, Thomas J Carmody2, Hisham M Ibrahim1, John C Markowitz3,4, Gabor I Keitner5, Susan G Kornstein6, Bruce Arnow7, Daniel N Klein8, Rachel Manber7, David L Dunner9, Alan J Gelenberg10, James H Kocsis3, Charles B Nemeroff11, Jan Fawcett12, Michael E Thase13, James M Russell14, Darlene N Jody15, Frances E Borian15 and Martin B Keller16
- 1Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA
- 2Academic Computing Services, University of Texas Southwestern Medical Center, Dallas, TX, USA
- 3Department of Psychiatry, Cornell University Medical College, New York, NY, USA
- 4Department of Psychiatry New York State Psychiatric Institute, New York, NY, USA
- 5Department of Psychiatry, Brown University and Rhode Island Hospital, Providence, RI, USA
- 6Department of Psychiatry, Virginia Commonwealth University, Richmond, VA, USA
- 7Department of Psychiatry & Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA
- 8Department of Psychology, State University of New York at Stony Brook, USA
- 9Department of Psychiatry & Behavioral Sciences, University of Washington, Seattle, WA, USA
- 10Department of Psychiatry, University of Arizona Health Sciences Center, Tucson, AZ, USA
- 11Department of Psychiatry & Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA
- 12Department of Psychiatry, Rush-St Luke's-Presbyterian Medical Center, Chicago, IL, USA
- 13Department of Psychiatry, Western Psychiatric Institute & Clinic, University of Pittsburgh Medical Center, Pittsburgh, PA, USA
- 14Department of Psychiatry & Behavioral Sciences, University of Texas Medical Branch, Galveston, TX, USA
- 15Bristol-Myers Squibb, Plainsboro, NJ, Atlanta, GA, USA
- 16Department of Psychiatry & Human Behavior, Brown University and Butler Hospital, Providence, RI, USA
Correspondence: Dr AJ Rush, Department of Psychiatry, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX 75390-9086, USA. Tel: 214 648 4601; Fax: 214 648 4612; E-mail: john.rush@utsouthwestern.edu
Received 17 June 2004; Revised 16 September 2004; Accepted 28 September 2004; Published online 1 December 2004.
Abstract
This study evaluated and compared the performance of three self-report measures: (1) 30-item Inventory of Depressive Symptomatology-Self-Report (IDS-SR30); (2) 16-item Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR16); and (3) Patient Global Impression-Improvement (PGI-I) in assessing clinical outcomes in depressed patients during a 12-week, acute phase, randomized, controlled trial comparing nefazodone, cognitive-behavioral analysis system of psychotherapy (CBASP), and the combination in the treatment of chronic depression. The IDS-SR30, QIDS-SR16, PGI-I, and the 24-item Hamilton Depression Rating Scale (HDRS24) ratings were collected at baseline and at weeks 1–4, 6, 8, 10, and 12. Response was defined a priori as a
50% reduction in baseline total score for the IDS-SR30 or for the QIDS-SR16 or as a PGI-I score of 1 or 2 at exit. Overall response rates (LOCF) to nefazodone were 41% (IDS-SR30), 45% (QIDS-SR16), 53% (PCI-I), and 47% (HDRS17). For CBASP, response rates were 41% (IDS-SR30), 45% (QIDS-SR16), 48% (PGI-I), and 46% (HDRS17). For the combination, response rates were 68% (IDS-SR30 and QIDS-SR16), 73% (PGI-I), and 76% (HDRS17). Similarly, remission rates were comparable for nefazodone (IDS-SR30=32%, QIDS-SR16=28%, PGI-I=22%, HDRS17=30%), for CBASP (IDS-SR30=32%, QIDS-SR16=30%, PGI-I=21%, HDRS17=32%), and for the combination (IDS-SR30=52%, QIDS-SR16=50%, PGI-I=25%, HDRS17=49%). Both the IDS-SR30 and QIDS-SR16 closely mirrored and confirmed findings based on the HDRS24. These findings raise the possibility that these two self-reports could provide cost- and time-efficient substitutes for clinician ratings in treatment trials of outpatients with nonpsychotic MDD without cognitive impairment. Global patient ratings such as the PGI-I, as opposed to specific item-based ratings, provide less valid findings.
Keywords:
chronic depression, psychotherapy, nefazodone, symptom measures
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