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

  1. 1Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA
  2. 2Academic Computing Services, University of Texas Southwestern Medical Center, Dallas, TX, USA
  3. 3Department of Psychiatry, Cornell University Medical College, New York, NY, USA
  4. 4Department of Psychiatry New York State Psychiatric Institute, New York, NY, USA
  5. 5Department of Psychiatry, Brown University and Rhode Island Hospital, Providence, RI, USA
  6. 6Department of Psychiatry, Virginia Commonwealth University, Richmond, VA, USA
  7. 7Department of Psychiatry & Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA
  8. 8Department of Psychology, State University of New York at Stony Brook, USA
  9. 9Department of Psychiatry & Behavioral Sciences, University of Washington, Seattle, WA, USA
  10. 10Department of Psychiatry, University of Arizona Health Sciences Center, Tucson, AZ, USA
  11. 11Department of Psychiatry & Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA
  12. 12Department of Psychiatry, Rush-St Luke's-Presbyterian Medical Center, Chicago, IL, USA
  13. 13Department of Psychiatry, Western Psychiatric Institute & Clinic, University of Pittsburgh Medical Center, Pittsburgh, PA, USA
  14. 14Department of Psychiatry & Behavioral Sciences, University of Texas Medical Branch, Galveston, TX, USA
  15. 15Bristol-Myers Squibb, Plainsboro, NJ, Atlanta, GA, USA
  16. 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.

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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 greater than or equal to50% 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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