Methodological issues in clinical trials of antidepressant medications: Perspectives from psychotherapy outcome research

Psychotherapy and Psychosomatics

Volumn 74, Issue 1, 2005, Pages 17-25

  Gaudiano, Brandon A ^a,c   Herbert, James D ^b  

^a BROWN UNIVERSITY   (United States)

^b DREXEL UNIVERSITY COLLEGE OF MEDICINE   (United States)

^c BUTLER HOSPITAL   (United States)

Author keywords

Antidepressants active placebos, psychotherapy outcome research; Psychotherapy outcome research, depression; Randomized controlled trials, antidepressants active placebos

Indexed keywords

ANTIDEPRESSANT AGENT; ATROPINE; BARBITURIC ACID DERIVATIVE; BENZODIAZEPINE; HYPERICUM PERFORATUM EXTRACT; NEUROLEPTIC AGENT; PAROXETINE; PLACEBO; SEROTONIN UPTAKE INHIBITOR; SERTRALINE; TRICYCLIC ANTIDEPRESSANT AGENT;

CLINICAL TRIAL; DEPRESSION; DROWSINESS; FOOD AND DRUG ADMINISTRATION; HEART DISEASE; HUMAN; INTERMETHOD COMPARISON; MAJOR DEPRESSION; MEDICAL RESEARCH; META ANALYSIS; NAUSEA; PRIORITY JOURNAL; PSYCHOTHERAPY; RATING SCALE; RELIABILITY; REVIEW; RISK FACTOR; SIDE EFFECT; SWEATING; TREATMENT OUTCOME; VISUAL IMPAIRMENT; XEROSTOMIA;

ANTIDEPRESSIVE AGENTS; DEPRESSIVE DISORDER, MAJOR; HUMANS; OUTCOME ASSESSMENT (HEALTH CARE); PSYCHOTHERAPY; RANDOMIZED CONTROLLED TRIALS;

EID: 11844301337     PISSN: 00333190     EISSN: None     Source Type: Journal    
DOI: 10.1159/000082022     Document Type: Review

References (70)

1. Kessler RC, Berglund P, Demler O, Jin R, Koretz D, Merikangas KR, Rush AJ, Walters EE, Wang PS: The epidemiology of major depressive disorder: Results from the National Comorbidity Survey Replication (NCS-R). JAMA 2003;289:3095-3105.
2. Antonuccio DO, Danton WG, DeNelsky GY, Greenberg RP, Gordon JS: Raising questions about antidepressants. Psychother Psychosom 1999;68:3-14.
3. Department of Health: Prescription Cost Analysis 1997. London, HMSO, 1998.
4. Gaudiano BA, Herbert JD: The antidepressant-placebo debate in the media: Balanced coverage or placebo hype? Sci Rev Ment Health Pract 2003;2:74-77.
5. Leber P: The use of placebo control groups in the assessment of psychiatric drugs: An historical context. Biol Psychiatry 2000;47:699-706.
6. Lohr JM, DeMaio C, McGlynn FD: Specific and nonspecific treatment factors in the experimental analysis of behavioral treatment efficacy. Behav Modif 2003;27:322-368.
7. White L, Tursky B, Schwartz GE: Placebo: Theory, Research, and Mechanisms. New York, Guilford, 1985.
8. Greenberg RP, Bornstein RF, Greenberg MD, Fisher S: A meta-analysis of antidepressant outcome under 'blinder' conditions. J Consult Clin Psychol 1992;60:664-669.
9. Quitkin FM, Rabkin JG, Gerald J, Davis JM, Klein DF: Validity of clinical trials of antidepressants. Am J Psychiatry 2000;157:327-337.
10. Kirsch I, Sapirstein G: Listening to Prozac but hearing placebo: A meta-analysis of antidepressant medication. Prevention & Treatment 1998;1:Article 0002a. Retrieved from: http://journals.apa.org/prevention/ volume1/pre0010002a.html.
11. Klein DF: Listening to meta-analysis but hearing bias. Prevention & Treatment 1998;1:Article 0006c. Retrieved from: http://journals.apa.org/ prevention/volume1/pre0010006c.html.
12. Klein DF: Reply to Kirsch's rejoinder regarding antidepressant meta-analysis. Prevention & Treatment 1998;1:Article 0008r. Retrieved from: http://journals.apa.org/prevention/volume1/pre0010008r.html.
13. Kirsch I: Reducing noise and hearing placebo more clearly. Prevention & Treatment 1998;1: Article 0007r. Retrieved from: http://journals.apa.org/ prevention/volume1/pre0010009r.html.
14. Kirsch I: On the importance of reading carefully: A response to Klein. Prevention & Treatment 1998;1:Article 0009r. Retrieved from: http://journals.apa.org/prevention/volume1/pre0010009r.html.
15. Kirsch I, Moore TJ, Scoboria A, Nicholls SS: The emperor's new drugs: An analysis of antidepressant medication data submitted to the U.S. Food and Drug Administration. Prevention & Treatment 2002;5:Article 23. Retrieved from: http://journals.apa.org/prevention/volume5/pre0050023a.
16. Rosenthal R: The 'file drawer problem' and tolerance for null results. Psychol Bull 1979;86:638-641.
17. Thase ME: Small effects are not trivial from a public health perspective. Psychiatric Times 2003;19(9). Retrieved from: http://www.psychiatrictimes.com/ p020909.html.
18. Smith D, Dempster C, Glanville J, Freemantle N, Anderson I: Efficacy and tolerability of venlafaxine compared with selective serotonin reuptake inhibitors and other antidepressants: A meta-analysis. Br J Psychiatry 2002;180:396-404.
19. Hypericum Depression Trial Study Group: Effect of Hypericum perforatum (St John's wort) in major depressive disorder: A randomized controlled trial. JAMA 2002;287:1807-1814.
20. Walsh BT, Seidman SN, Sysko R, Gould M: Placebo response in studies of major depression: Variable, substantial, and growing. JAMA 2002;287:1840-1847.
21. Greenberg RP, Fisher S: Examining antidepressant effectiveness: Findings, ambiguities, and some vexing puzzles; in Fisher S (ed): The Limits of Biological Treatment for Psychological Distress: Comparisons with Psychotherapy and Placebo. Hillsdale, Erlbaum, 1989, pp 1-37.
22. Double DB: Unblinding in trials of the withdrawal of anticholinergic agents in patients maintained on neuroleptics. J Nerv Ment Dis 1995;183:599-602.
23. Bystritsky A, Waikar SV: Inert placebo versus active medication: Patient blindability in clinical pharmacological trials. J Nerv Ment Dis 1994;182:485-487.
24. White K, Kando J, Park T, Waternaux C, Brown WA: Side effects and the 'blindability' of clinical drug trials. Am J Psychiatry 1992;149:1730-1731.
25. Piasecki MP, Antonuccio DO, Steinagel GM, Kohlenberg BS, Kafadar K: Penetrating the blind in a study of an SSRI. J Behav Ther Exp Psychiatry 2002;33:67-71.
26. Sharpe L, Ryan B, Allard S, Sensky T: Testing for the integrity of blinding in clinical trials: How valid are forced choice paradigms? Psychother Psychosom 2003;72:128-131.
27. Basoglu M, Marks I, Livanou M, Swinson R: Double-blindness procedures, rater blindness, and ratings of outcome: Observations from a controlled trial. Arch Gen Psychiatry 1997;54:744-748.
28. Thomson R: Side effects and placebo amplification. Br J Psychiatry 1982;140:64-68.
29. Moncrieff J, Wessley S, Hardy R: Meta-analysis of trials comparing antidepressants with active placebos. Br J Psychiatry 1998;172:227-231.
30. Moncrieff J, Wessely S, Hardy R: Active placebos versus antidepressants for depression (Cochrane Review). The Cochrane Library 2002, issue 1. Oxford, Update Software.
31. Quitkin FM: Placebos, drug effects, and study design: A clinician's guide. Am J Psychiatry 1999;156:829-836.
32. Cooney JM: Active placebos in antidepressant trials. Br J Psychiatry 1998;172:541-542.
33. Salamone JD: A critique of recent studies on placebo effects of antidepressants: Importance of research on active placebos. Psychopharmacology 2000;152:1-6.
34. Klein DF: Flawed meta-analyses comparing psychotherapy with pharmacology. Am J Psychiatry 2000;157:1204-1211.
35. Otto MW, Nierenberg AA: Assay sensitivity, failed clinical trials, and the conduct of science. Psychother Psychosom 2002;71:241-243.
36. Moncrieff J: Are antidepressants overrated? A review of methodological problems in antidepressant trials. J Nerv Ment Dis 2001;198:288-295.
37. Tedlow J, Fava M, Uebelacker J, Nierenberg AA, Alpert JE, Rosenbaum J: Outcome definitions and predictors in depression. Psychother Psychosom 1998;67:266-270.
38. Sensky T: The utility of systematic reviews: The case of psychological debriefing after trauma. Psychother Psychom 2003;72:171-175.
39. Khan A, Warner HA, Brown WA: Symptom reduction and suicide risk in patients treated with placebo in antidepressant clinical trials: An analysis of the Food and Drug Administration database. Arch Gen Psychiatry 2000;57:311-317.
40. Healy D: Lines of evidence on the risks of suicide with selective serotonin reuptake inhibitors. Psychother Psychosom 2003;72:71-79.
41. Schatzberg AF, Cole JO: Benzodiazepines in depressive disorders. Arch Gen Psychiatry 1978;35:1359-1365.
42. Klein DF, Thase ME, Endicott J, Adler L, Glick I, Kalali A, Leventer S, Mattes J, Ross P, Bystritsky A: Improving clinical trials: American Society of Clinical Psychopharmacology recommendations. Arch Gen Psychiatry 2002;59:272-278.
43. Fava M, Evins AE, Dorer DJ, Shoenfeld DA: The problem of the placebo response in clinical trials for psychiatric disorders: Culprits, possible remedies, and a novel study design approach. Psychother Psychosom 2003;72:115-127.
44. TenHave TR, Coyne J, Salzer M, Katz I: Research to improve the quality of care for depression: Alternatives to the simple randomized clinical trial. Gen Hosp Psychiatry 2003;25:115-123.
45. Luborsky L, Diguer L, Seligman DA, Rosenthal R, Krause ED, Johnson S, Halperin G, Bishop M, Berman JS, Schweizer E: The researcher's own therapy allegiances: A 'wild card' in comparisons of treatment efficacy. Clin Psychol Sci Pract 1999;6:95-106.
46. Herbert JD: The science and practice of empirically supported treatments. Behav Modif 2003;27:412-430.
47. Benedetti F, Maggi G, Lopiano L: Open versus hidden medical treatments: The patient's knowledge about a therapy affects the therapy outcome. Prevention & Treatment 2003;6:Article 1. Retrieved from: http://journals.apa.org/ prevention/volume6/pre0060001a.html.
48. Miller JL, Delgado PL, Salomon RM, Berman R, Krystal JH, Heninger GR, Charney DS: Clinical and biochemical effects of catecholamine depletion on antidepressant-induced remission of depression. Arch Gen Psychiatry 1996;53:117-128.
49. Young LT, Bakish D, Beaulieu S: The neurobiology of treatment response to antidepressants and mood stabilizing medications. J Psychiatry Neurosci 2002;27:260-265.
50. Kazdin AE: Research Design in Clinical Psychology, ed 3. Boston, Allyn & Bacon, 1998.
51. Borkovec TD, Newman MG, Pincus AL, Lytle R: A component analysis of cognitive-behavioral therapy for generalized anxiety disorder and the role of interpersonal problems. J Consult Clin Psychol 2002;70:288-298.
52. Fava GA: Conflict in interest in psychopharmacology: Can Dr. Jekyll still control Mr. Hyde? Psychother Psychosom 2004;73:1-4.
53. Kjaergard LL, Als-Nielsen B : Association between competing interests and authors' conclusions: Epidemiological study of randomized clinical trials published in the BMJ. BMJ 2002;325:249.
54. Kirsch I, Lynn SJ: Automaticity in clinical psychology. Am Psychol 1999;54:504-515.
55. Holt CS, Heimberg RG: The Reaction to Treatment Questionnaire: Measuring treatment credibility and outcome expectancies. Behav Ther 1990;13:213-214.
56. Antonuccio DO, Burns DD, Danton WG: Antidepressants: A triumph of marketing over science? Prevention & Treatment 2002;5:Article 25. Retrieved from: http://journals.apa.org/prevention/volume5/pre0050025c.html.
57. Even C, Siobud-Dorocant E, Dardennes RM: Critical approach to antidepressant trials: Blindness protection is necessary, feasible, and measurable. Br J Psychiatry 2000;177:47-51.
58. Petkova E, Quitkin FM, McGrath PJ, Stewart JW, Klein DF: A method to quantify rater bias in antidepressant trials. Neuropsychopharmacology 2000;22:559-565.
59. Katz RJ, Deveaugh-Geiss J: The issue of side effects and the 'blindability' of clinical drug trials. Am J Psychiatry 1994;150:1759-1760.
60. Ross DC, Quitkin FM, Klein DF: A typological model for estimation of drug and placebo effects in depression. J Clin Psychopharmacol 2002;22:414-418.
61. Stassen HH, Delini-Stula A, Angst J: Time course of improvement under antidepressant treatment: A survival-analytical approach. Eur Neuropsychopharmacol 1993;3:127-135.
62. Herbert JD, Rheingold AA, Gaudiano BA, Harwell VD: Standard versus extended cognitive behavior therapy for social anxiety disorder: A randomized-controlled trial. Behav Cogn Psychother 2004;32:131-147.
63. Haynes SN, O'Brien WH: Principles and Practice of Behavioral Assessment. New York, Kluwer/Plenum Press, 2000.
64. Herbert JD, Rheingold AA, Brandsma LL: Assessment of social anxiety and social phobia; in Hofmann SG, DiBartolo PM (eds): From Social Anxiety to Social Phobia: Multiple Perspectives. New York, Guilford, 2001, pp 20-45.
65. Jacobson NS, Truax P: Clinical significance: A statistical approach to defining meaningful change in psychotherapy research. J Consult Clin Psychol 1991;59:12-19.
66. Möller HJ: Methodological aspects in the assessment of severity of depression by the Hamilton Depression Scale. Eur Arch Psychiatry Clin Neurosci 2001;251(Suppl 2):II13-II20.
67. Beck AT, Rush AJ, Shaw BF, Emery G: Cognitive Therapy of Depression. New York, Guilford, 1979.
68. Jacobson NS, Dobson KS, Truax PA, Addis ME, Koerner K, Gollan JK, Gortner E, Prince SE: A component analysis of cognitive-behavioral treatment for depression. J Consult Clin Psychol 1996;64:295-304.
69. Kendall PC, Holmbeck G, Verduin T: Methodology, design, and evaluation in psychotherapy research; in Lamberg MJ (ed): Bergin and Garbield's Handbook of Psychotherapy and Behavior Change, ed 5. New York, Wiley, 2004, p 43.
70. Moher D, Schulz KF, Altman DG: The CONSORT statement: Revised recommendations for improving the quality of reports of parallel-group randomized trials. Ann Intern Med 2001;134:657-662.