Validity of clinical trials of antidepressants

American Journal of Psychiatry

Volumn 157, Issue 3, 2000, Pages 327-337

  Quitkin, Frederic M ^a   Rabkin, Judith G ^b   Gerald, Jessica ^b   Davis, John M ^b   Klein, Donald F ^b  

^a New York Presbyterian Columbia University Medical Center   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

ALPRAZOLAM; AMITRIPTYLINE; AMOXAPINE; AMPHETAMINE DERIVATIVE; ANTIDEPRESSANT AGENT; CENTRAL STIMULANT AGENT; CHLORDIAZEPOXIDE; DEXAMPHETAMINE; FENFLURAMINE; IMIPRAMINE; LITHIUM; MAPROTILINE; MEPROBAMATE; METHYLPHENIDATE; NIALAMIDE; NICOTINIC ACID; PERPHENAZINE; PLACEBO; RESERPINE; SECOBARBITAL; TRAZODONE;

ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEPRESSION; DRUG EFFICACY; DRUG USE; HUMAN; META ANALYSIS; PRIORITY JOURNAL; PSYCHOTHERAPY; VALIDATION PROCESS;

ANTIDEPRESSIVE AGENTS; CLINICAL TRIALS; DEPRESSIVE DISORDER; HUMANS; PLACEBO EFFECT; PLACEBOS; PREJUDICE; PSYCHOTHERAPY; RANDOMIZED CONTROLLED TRIALS; REPRODUCIBILITY OF RESULTS; RESEARCH DESIGN; TREATMENT OUTCOME;

EID: 0034114435     PISSN: 0002953X     EISSN: None     Source Type: Journal    
DOI: 10.1176/appi.ajp.157.3.327     Document Type: Article

References (77)

1. 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
2. Greenberg RP, Fisher S: A second opinion: rethinking the claims of biological psychiatry, in The Limits of Biological Treatments for Psychological Distress: Comparisons With Psychotherapy and Placebo. Edited by Fisher S, Greenberg RP. Hillsdale, NJ, Lawrence Erlbaum Associates, 1989, pp 309-336
3. Greenberg RP, Fisher S: Examining antidepressant effectiveness: findings, ambiguities, and some vexing puzzles. Ibid, pp 1-37
4. Fisher S, Greenberg RP: How sound is the double-blind design for evaluating psychotropic drugs? J Nerv Ment Dis 1993; 181:345-350
5. Greenberg RP, Bornstein RF, Zborowski MJ, Fisher S, Greenberg MD: A meta-analysis of fluoxetine outcome in the treatment of depression. J Nerv Ment Dis 1994; 182:547-551
6. Fisher S, Greenberg R (eds): From Placebo to Panacea: Putting Psychiatric Drugs to the Test. New York, John Wiley & Sons, 1997
7. Antonuccio DO, Danton WG, DeNelsky GY: Psychotherapy versus medication for depression: challenging the conventional wisdom with data. Professional Psychol: Res and Practice 1995; 26:574-585
8. Antonuccio DO, Danton WG, DeNelsky GY, Greenberg RP, Gordon JS: Raising questions about antidepressants. Psychother Psychosom 1999; 68:3-14
9. Moncrieff J, Wessely S, Hardy R: Meta-analysis of trials comparing antidepressants with active placebos. Br J Psychiatry 1998; 172:227-231
10. Kirsch I, Sapirstein G: Listening to Prozac but hearing placebo: a meta-analysis of antidepressant medications, in How Expectancies Shape Experience. Edited by Kirsch I. Washington, DC, American Psychological Association, 1999, pp 303-320
11. Goleman D: Psychologists dispute value of antidepressants. New York Times, Nov 29, 1995, p C10
12. Blakeslee S: Placebos Prove so Powerful Even Experts Are Surprised. New York Times (Science Times), Oct 13, 1998, p C5
13. Schoofs M: Healing head trips: doctors explore the astonishing power of placebos. Village Voice, May 6-12, 1998, p 46
14. Holmes L: Treatment e-journal is reborn. About.com, June 29, 1998 (http://mentalhealth.miningco.com/library/weekly/ aa062998.htm)
15. Horgan J: Science triumphant? not so fast. New York Times, Jan 19, 1998, p A17
16. Horgan J: Placebo nation. New York Times, March 21, 1999, section 4, p 15
17. Day M: Mostly in the mind. New Scientist, July 11, 1998 (http: //www.newscientist.com/ns/980711/nantidepressant.html)
18. American Psychological Association Press Release: Placebo effect accounts for fifty percent of improvement in depressed patients taking antidepressants Self-Help & Psychology Magazine, May 21, 1998 (http://www.shpm.com/articles/depress/ antidprs.html)
19. American Psychological Association Press Release: Antidepressant medications: miracle drugs or placebos with a buzz? APA Public Communications, July 16, 1998 (http://www.apa. org/releases/debate. html)
20. Munoz RF, Hollon SD, McGrath E, Rehm LP, VandenBos GR: On the AHCPR depression primary care guidelines: further considerations for practitioners. Am Psychol 1994; 49:42-61
21. Young SM: The use of placebos in psychiatry: a response to the draft document prepared by the TRI-Council Working Group. J Psychiatry Neurosci 1996; 21:235-238
22. Healy D: Commentary: meta-analysis of trials comparing antidepressants with active placebos. Br J Psychiatry 1998; 172: 232-234
23. Enserink M: Can the placebo be the cure? Science 1999; 284: 238-240
24. Hirschfeld R, Keller M, Panico S, Arons B, Barlow D, Davidoff F, Endicott J, Froom J, Goldstein M, Gorman J, Guthrie D, Marek R, Maurer T, Meyer R, Phillips K, Ross J, Schwenk T, Sharfstein S, Thase M, Wyatt R: The National Depressive and Manic-Depressive Association Consensus Statement on the Undertreatment of Depression. JAMA 1997; 277:333-340
25. Thase M: How should efficacy be evaluated in randomized clinical trials of treatments for depression? J Clin Psychiatry 1999; 60(suppl 4):23-31
26. Treatment of depression - newer pharmacotherapies: summary, evidence report/technology assessment number 7. Rockville, Md, Agency for Health Care Policy and Research, March 1999 (http://www.ahcpr.gov/clinic/deprsumm.htm)
27. Klawansky S: Meta-analysis on the treatment of depression in late life, in Diagnosis and Treatment of Depression in Late Life: Results of the NIH Consensus Development Conference. Edited by Schneider LS, Reynolds CF III, Liebowitz BD, Freidhoff AJ. Washington, DC, American Psychiatric Press. 1994, pp 333-352
28. Klerman GL, Cole JO: Clinical pharmacology of imipramine and related compounds. Pharmacol Rev 1965; 17:101-141
29. Ather SA, Ankier SI, Middleton RSW: A double-blind evaluation of trazodone in the treatment of depression in the elderly. Br J Clin Pract 1985; 39:192-199
30. Blacker R, Shanks NJ, Chapman N, Davey A: The drug treatment of depression in general practice: a comparison of nocte administration of trazodone with mianserin, dothiepin, and amitriptyline. Psychopharmacology (Berl) 1988; 95:18-24
31. Klieser E, Lehmann E: Experimental comparison between the effect of standardized trazodone-amitriptyline and placebo treatment in vitalized depressive patients. Psychopharmacology (Berl) 1988; 95:3-5
32. Klieser E, Lehmann E: Experimental examination of trazodone. Clin Neuropharmacol 1989; 12(suppl 1):S18-S24
33. McNair DM, Kahn RJ, Frankenthaler LM, Faldetta LL: Amoxapine and amitriptyline, I: relative speed of antidepressant action. Psychopharmacology (Berl) 1984; 83:129-133
34. McNair DM, Kahn RJ, Frankenthaler LM, Faldetta LL: Amoxapine and amitriptyline, II: specificity of cognitive effects during brief treatment of depression. Psychopharmacology (Berl) 1984; 83:134-139
35. Quitkin FM, Rabkin JG, Ross D, McGrath PJ: Duration of antidepressant drug treatment: what is an adequate trial? Arch Gen Psychiatry 1984; 41:238-245
36. Donovan SJ, Quitkin FM, Stewart JW, Ocepek-Welikson K, Harrison W, McGrath PJ, Nunes EV, Wager S, Tricamo E: Duration of antidepressant trials: clinical and research implications. J Clin Psychopharmacol 1994; 14:64-66
37. Mantel N, Haenszel W: Statistical aspect of the analysis of data from retrospective studies of disease. J Natl Cancer Inst 1959; 22:719-748
38. Leber P: The future of controlled clinical trials. Psychopharmacol Bull 1993; 27:3-8
39. Leber P: There is an alternative to the randomized-controlled trials. Psychiatr Annals 1995; 25:401-403
40. Lambert MJ, Hatch DR, Kingston MD, Edwards BC: Zung, Beck, and Hamilton rating scales as measures of treatment outcome: a meta-analytic comparison. J Consult Clin Psychol 1986; 54:54-59
41. Kellner R, Simpson GM, Sheffield BF: The value of self-rating scales in drug trials (proceedings). Psychopharmacol Bull 1977; 13:42-43
42. Quitkin FM, Stewart JW, McGrath PJ, Tricamo E, Rabkin JG, Ocepek-Welikson K, Nunes E, Harrison W, Klein DF: Columbia atypical depression: a subgroup of depressives with better response to MAOI than to tricyclic antidepressants or placebo. Br J Psychiatry Suppl 1993; 21:30-34
43. Cohen J: Statistical Power Analysis for Behavioral Sciences, revised ed. San Diego, Academic Press, 1977
44. Thomson R: Side effects and placebo amplification. Br J Psychiatry 1982; 140:64-68
45. Friedman AS, Granick S, Cohen HW, Cowitz B: Imipramine (Tofranil) vs placebo in hospitalized psychotic depressives (a comparison of patients' self-ratings, psychiatrists' ratings and psychological test scores). J Psychiatr Res 1966; 4:13-36
46. Hollister L, Overall J, Johnson M, Pennington V, Katz G, Shelton J: Controlled comparison of amitriptyline, imipramine, and placebo in hospitalized depressed patients. J Nerv Ment Dis 1964; 139:370-375
47. Hussain Z: Drugs in depressive illness. Br Med J 1970; 1:482
48. Uhlenhuth E, Park L: The influence of medication (imipramine) and doctor in relieving depressed psychoneurotic outpatients. J Psychiatr Res 1963; 2: 101-122
49. Wilson I, Vernon J, Sandiler M: A controlled study of treatment of depression. J Neuropsychiatry 1963; 4:331-337
50. Daneman E: Imipramine in office management of depressive reactions (a double blind clinical study). Dis Nerv Syst 1961; 22:213-217
51. Fahy P, Imlah N, Harrington J: A controlled comparison of electroconvulsive therapy, imipramine and thiopentone sleep in depression. J Neuropsychiatry 1963; 4:310-314
52. McLean PD, Hakstian AR: Clinical depression: comparative efficacy of outpatient treatments. J Consult Clin Psychol 1979; 47:818-836
53. Weintraub W, Aronson H: Clinical judgment in psychopharmacological research. J Neuropsychiatry 1963; 4:65-70
54. Friedman AS: Interaction of drug therapy with marital therapy in depressive patients. Arch Gen Psychiatry 1975; 32-619-637
55. Rabkin JG, Markowitz JS, Stewart JW, McGrath PJ, Harrison W, Quitkin FM, Klein DF: How blind is blind? assessment of patient and doctor medication guesses in a placebo-controlled trial of imipramine and phenelzine. Psychiatry Res 1986; 19:75-86
56. Blackburn IM, Bishop S, Glen Al, Whalley LJ, Christie JE: The efficacy of cognitive therapy in depression: a treatment trial using cognitive therapy and pharmacotherapy, each alone and in combination. Br J Psychiatry 1981; 139:181-189
57. Murphy GE, Simmons AD, Wetzel RD, Lustman PJ: Cognitive therapy and pharmacotherapy: single and together in the treatment of depression. Arch Gen Psychiatry 1983; 41:33-41
58. Weissman MM, Prusoff BA, DiMascio A, Neu C, Goklaney M, Klerman GL: The efficacy of drugs and psychotherapy in the treatment of acute depressive episodes. Am J Psychiatry 1979; 136:555-558
59. Bellack AS, Hersen M, Himmelhoch J: Social skills training compared with pharmacotherapy and psychotherapy in the treatment of unipolar depression. Am J Psychiatry 1981; 138: 1562-1567
60. Beutler LE, Scogin F, Kirkish P, Schretlen D, Corbishley A, Hamblin D, Meredith K, Potter R, Levenson A, Bamford CR: Group cognitive therapy and alprazolam in the treatment of depression in older adults. J Consult Clin Psychol 1987; 55: 550-556
61. McLean P, Hackstian A; Clinical depression: comparative efficacy of outpatient treatments. J Consult Clin Psychol 1979; 47:818-836
62. Klein DF: Preventing hung juries about therapy studies. J Consult Clin Psychol 1996; 64:81-87
63. Rush AJ, Beck AT, Kovacs M, Hollon S: Comparative efficacy of cognitive therapy and pharmacotherapy in the treatment of depressed outpatients. Cognitive Therapy Res 1977; 1:17-37
64. Robinson LA, Berman JS, Neimeyer RA: Psychotherapy for the treatment of depression. Psychol Bull 1990, 108:30-49
65. Elkin I, Shea MT, Watkins JT, Imber SD, Sotsky SM, Collins JF, Glass DR, Pilkonis PA, Leber WR, Docherty JP, Fiester SJ, Parloff MB: National Institute of Mental Health Treatment of Depression Collaborative Research Program: general effectiveness of treatments. Arch Gen Psychiatry 1989; 46:971-982
66. Elkin I, Gibbons RD, Shea MT, Sotsky SM, Watkins JT, Pilkonis PA, Hedeker D: Initial severity and differential treatment outcome in the National Institute of Mental Health Treatment of Depression Collaborative Research Program. J Consult Clin Psychol 1995; 63:841-847
67. Klein DF, Ross DC: Re-analysis of the National Institute of Mental Health Treatment of Depression Collaborative Research Program General Effectiveness Report. Neuropsychopharmacology 1993, 8:241-252
68. Sotsky SM, Simmens SJ: Pharmacotherapy response in atypical depression: findings from the NIMH Treatment of Depression Collaborative Research Program, in DSM-IV Sourcebook, vol 4. Edited by Widiger TA, Frances AJ, Pincus HA, Ross R, First MB, Davis WW. Washington, DC, American Psychiatric Association, 1996, pp 143-156
69. Stewart JW, Garfinkel R, Nunes EV, Klein DF: Atypical depression and treatment response in the NIMH Treatment of Depression Collaborative Research Program. J Clin Psychopharmacol 1998; 18:429-434
70. Zisook S, Shuchter SR, Gallagher T, Sledge P: Atypical depression in an outpatient population. Depression 1993; 1: 268-274
71. Luborsky L, Diguer L, Seligman D, Rosenthal R, Krause E, 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 and Practice 1999; 6:95-106
72. Shaw B: How to use the allegiance effect to maximize competence and therapeutic outcomes. Clin Psychol - Sci and Practice 1999; 6:131-132
73. Hollon S: Allegiance effects in treatment research: a commentary. Clin Psychol - Sci and Practice 1999; 6:107-112
74. McGrath PJ, Stewart JW, Nunes EV, Ocepek-Welikson K, Rabkin JG, Quitkin FM, Klein DF: A double-blind crossover trial of imipramine and phenelzine for outpatients with treatment-refractory depression. Am J Psychiatry 1993; 150:118-123
75. Davis JM, Wang Z, Janicak PG: Psychiatric medication compares favorably to drugs used in internal medicine: a metaanalysis (abstract). Schizophr Res 1995; 15:148
76. Teicher MH, Glod C, Cole JO: Emergence of intense suicidal preoccupation during fluoxetine treatment. Am J Psychiatry 1990; 147:207-210
77. Andrews G: Randomized controlled trials in psychiatry: important but poorly accepted. Br Med J 1999; 319:562-564