Use of placebo control groups in evaluating efficacy of treatment of unipolar major depression

Biological Psychiatry

Volumn 47, Issue 8, 2000, Pages 736-744

  Schatzberg, Alan F ^a   Kraemer, Helena C ^a  

^a STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Antidepressants; Major depression; Outcomes; Placebo; Randomized controlled trial

Indexed keywords

ANTIDEPRESSANT AGENT; FLUOXETINE; PLACEBO;

CLINICAL PROTOCOL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; DEPRESSION; DISEASE SEVERITY; DRUG EFFICACY; HUMAN; METHODOLOGY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RELIABILITY; REVIEW; TREATMENT OUTCOME;

ANTIDEPRESSIVE AGENTS; CLINICAL TRIALS; DEPRESSIVE DISORDER, MAJOR; HUMANS; PLACEBOS; PSYCHIATRIC STATUS RATING SCALES; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

EID: 0034655666     PISSN: 00063223     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0006-3223(00)00846-5     Document Type: Review

References (46)

1. Anton R.F. Jr, Burch E.A. Jr. Amoxapine vs. amitriptyline combined with perphenazine in the treatment of psychotic depression. Am J Psychiatry. 147:1990;1203-1208.
2. Bialik R.J., Ravindran A.V., Bakish D., Lapierre Y.D. A comparison of placebo responders and nonresponders in subgroups of depressive disorder. J Psychiatry Neurosci. 20:1995;265-270.
3. Brown W.A. Placebo as a treatment for depression. Neuropsychopharmacology. 10:1994;265-269.
4. Brown W.A., Dornseif B.E., Wernicke J.F. Placebo response in depression A search for predictors . Psychiatry Res. 26:1988;259-264.
5. Brown W.A., Johnson M.F., Chen M.-G. Clinical features of depressed patients who do and do not improve with placebo. Psychiatry Res. 41:1992;203-214.
6. Calabrese J.R., Bowden C.L., Sachs G.S., Ascher J.A., Monaghan E., Rudd G.D. A double-blind placebo-controlled study of lamotrigine monotherapy in outpatients with bipolar I depression. J Clin Psychiatry. 60:1999;79-88.
7. Campbell D.T., Kenny D.A., Reichardt C.S. A Primer on Regression Artifacts. 1999;Guilford, New York.
8. Cohen J. The cost of dichotomization. Appl Psychol Meas. 7:1983;249-253.
9. Cohen J. Statistical Power Analysis for the Behavioral Sciences. 1988;Lawrence Erlbaum, Hillsdale, NJ.
10. Cohen J. The earth is round (p < .05). Am Psychol. 49:1995;997-1003.
11. Doogan D.P., Caillard V. Sertraline in the prevention of depression. Br J Psychiatry. 160:1992;217-222.
12. Fairchild C.J., Rush J.A., Versavada N., Giles D.E., Khatami M. Which depressions respond to placebo. Psychiatry Res. 18:1986;217-226.
13. Faries DM, Heiligenstein J, DeBrota DJ, Potter WZ (1999, June): The double-blind variable placebo lead in period: Results from two antidepressant studies. Poster presented at the 39th annual meeting of the New Clinical Drug Evaluation Unit, Boca Raton, FL.
14. Frank E., Kupfer D.J., Perel J.M., Cornes C., Jarrett D.B., Mallinger A.G., et al. Three-year outcomes for maintenance therapies in recurrent depression. Arch Gen Psychiatry. 47:1990;1093-1099.
15. Glassman A.H., Roose S.P. Delusional depression A distinct clinical entity? Arch Gen Psychiatry. 38:1981;424-427.
16. Hunter J.E. Needed A ban on the significance test . Psychol Sci. 8:1997;3-7.
17. Jacobson N.S., Truax P. Clinical significance A statistical approach to defining meaningful change in psychotherapy research . J Consult Clin Psychol. 59:1991;12-19.
18. Keller M.B., Kocsis J.H., Thase M.E., Gelenberg A.J., Koran L., Schatzberg A.F., et al. Maintenance phase efficacy of sertraline for chronic depression A randomized controlled trial . JAMA. 280:1998;1665-1672.
19. Khan A., Dager S.R., Cohen S., Avery D.H., Scherzo B., Dunner D.L. Chronicity of depressive episode in relation to antidepressant-placebo response. Neuropsychopharmacology. 4:1991;125-130.
20. Kirsch I, Sapirstein G. Listening to Prozac but hearing placebo: A meta-analysis of antidepressant medication. Available at: http://journals.apa.org/prevention/volume1/pre0010002a.html. Accessed March 20, 2000.
21. Kraemer H.C. Reporting the size of effects in research studies to facilitate assessment of practical or clinical significance. Psychoneuroendocrinology. 17:1993;527-536.
22. Kraemer H.C., Kazdin A.E., Offord D.R., Kessler R.C., Jensen P.S., Kupfer D.J. Measuring the potency of a risk factor for clinical or policy significance. Psychol Methods. 4:1999;257-271.
23. Kraemer H.C., Thiemann S. How Many Subjects? Statistical Power Analysis in Research. 1987;Sage, Newbury Park, CA.
24. Kraemer H.C., Thiemann S. A strategy to use "soft" data effectively in randomized controlled clinical trials. J Consult Clin Psychol. 57:1989;148-154.
25. Krantz D.H. The null hypothesis testing controversy in psychology. J Am Stat Assoc. 44:1999;1372-1381.
26. Lau J., Elliott M.A., Jimenez-Silva J., Kupelnick B., Mosteller F., Chalmers T.C. Cumulative meta-analysis of therapeutic trials for myocardial infarction. N Engl J Med. 327:1992;248-254.
27. Loebel A.D., Hyde T.S., Dunner D.L. Early placebo response in anxious and depressed patients. J Clin Psychiatry. 47:1986;230-233.
28. Meinert C.L. Clinical Trials Design, Conduct, and Analysis . 1986;Oxford University Press, New York.
29. Miller R.G.J. Survival Analysis. 1981;Wiley, New York.
30. Montgomery S.A., Dufour H., Brion S., Gailledeau J., Laqueille X., Ferrey G., et al. The prophylactic efficacy of fluoxetine in unipolar depression. Br J Psychiatry. 153:(suppl 3):1988;69-76.
31. Montgomery S.A., Dunbar G. Paroxetine is better than placebo in relapse prevention and the prophylaxis of recurrent depression. Int Clin Psychopharmacol. 8:1993;189-195.
32. A 14-month randomized clinical trial of treatment strategies for attention-deficit/hyperactivity disorder. Arch Gen Psychiatry. 56:1999;1073-1086.
33. Moderators and mediators of treatment response for children with attention-deficit/hyperactivity disorder. Arch Gen Psychiatry. 56:1999;1088-1096.
34. Paykel E.S., Hollyman J.A., Freeling P., Sedwick P. Predictors of therapeutic benefit from amitriptyline in mild depression A general practice placebo-controlled trial . J Affect Disord. 14:1988;83-95.
35. Quitkin F., Rabkin J., Markowitz J., Stewart J.W., McGrath P.J., Harrison W. Use of pattern analysis to identify true drug response A replication . Arch Gen Psychiatry. 44:1987;259-264.
36. Quitkin F., Rabkin J., Ross D., Stewart J.W. Identification of true drug response to antidepressants Use of pattern analysis . Arch Gen Psychiatry. 41:1984;782-786.
37. Schatzberg AF (1995, May-June): Determinants of placebo response rates in clinical trials. Paper presented at the 35th annual meeting of the New Clinical Drug Evaluation Unit, Orlando, Florida.
38. Schatzberg A.F., Rothschild A.J. Psychotic (delusional) major depression Should it be included as a distinct syndrome in DSM-IV? Am J Psychiatry. 149:1992;733-745.
39. Shrout P.E. Should significance tests be banned? Introduction to a special section exploring the pros and cons. Psychol Sci. 8:1997;1-2.
40. Singer J.D., Willett J.B. Modeling the days of our lives Using survival analysis when designing and analyzing longitudinal studies of duration and the timing of events . Psychol Bull. 110:1991;268-290.
41. Stewart J.W., Quitkin F.M., Liebowitz M.R., McGrath P.J., Harrison W.M., Klein D.F. Efficacy of desipramine in depressed outpatients. Arch Gen Psychiatry. 40:1983;202-207.
42. Stewart J.W., Quitkin F.M., McGrath P.J., Amsterdam J., Fava M., Fawcett J., et al. Use of pattern analysis to predict differential relapse of remitted patients with major depression during 1 year of treatment with fluoxetine or placebo. Arch Gen Psychiatry. 55:1998;334-343.
43. Terra J.L., Montgomery S.A. Fluvoxamine prevents recurrence of depression Results of a long-term, double-blind, placebo-controlled study . Int Clin Psychopharmacol. 13:1998;55-62.
44. Trivedi M.H., Rush J. Does a placebo run-in or a placebo treatment cell affect the efficacy of antidepressant medications? Neuropsychopharmacology. 11:1994;33-43.
45. Wilcox C.S., Cohn J.B., Linden R.D., Heiser J.F., Lucas P.B., DeAnn L.M. Predictors of placebo response A retrospective analysis . Psychopharmacol Bull. 28:1992;157-162.
46. Willett J.B., Singer J.D. Investigating onset, cessation, relapse and recovery Why you should, and how you can, use discrete-time survival analysis to examine event occurrence . J Consult Clin Psychol. 61:1993;952-965.