Placebo effect in randomized, controlled studies of acute bipolar mania and depression

Biological Psychiatry

Volumn 47, Issue 8, 2000, Pages 748-755

  Keck Jr , Paul E ^a   Welge, Jeffrey A ^b   McElroy, Susan L ^a   Arnold, Lesley M ^a   Strakowski, Stephen M ^a  

^a UNIVERSITY OF CINCINNATI   (United States)

^b UNIVERSITY OF CINCINNATI MEDICAL CENTER   (United States)

Author keywords

Bipolar disorder; Clinical trials; Depression; Mania; Placebo

Indexed keywords

CHLORPROMAZINE; CLONIDINE; FLUOXETINE; IMIPRAMINE; LITHIUM; OLANZAPINE; PAROXETINE; PLACEBO; PSYCHOTROPIC AGENT; TRANYLCYPROMINE; VALPROATE SEMISODIUM; VERAPAMIL;

ACUTE DISEASE; ARTICLE; BIPOLAR DEPRESSION; CLINICAL PROTOCOL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; HUMAN; MANIA; MANIC DEPRESSIVE PSYCHOSIS; META ANALYSIS; METHODOLOGY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL;

EID: 0342424182     PISSN: 00063223     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0006-3223(99)00311-X     Document Type: Review

References (49)

1. Aldenhoff J.B., Schlegal S., Heuser I., Wetzel H. Antimanic effects of the calcium-antagonist D600. A double-blind placebo-controlled study. Clin Neuropharmacol. 9:(suppl 4):1986;553-555.
2. Diagnostic and Statistical Manual of Mental Disorders. 3rd ed rev. 1987;American Psychiatric Press, Washington, DC.
3. Diagnostic and Statistical Manual of Mental Disorders. 4th ed. 1994;American Psychiatric Press, Washington, DC.
4. Ballenger J.C., Post R.M. Therapeutic effects of carbamazepine in affective illness A preliminary report . Commun Psychopharmacol. 2:1978;159-175.
5. Baron M., Gershon E.S., Rudy V. Lithium carbonate response in depression. Arch Gen Psychiatry. 32:1975;1107-1111.
6. Bowden C.L., Brugger A.M., Swann A.C., Calabrese J.R., Janicak P.G., Petty F., et al. Efficacy of divalproex vs lithium and placebo in the treatment of mania. JAMA. 271:1994;918-924.
7. Bowden C.L., Calabrese J.R., Wallin B.A., Swann A.C., McElroy S.L., Risch S.C., et al. Who enters therapeutic trials? Illness characteristics of patients in clinical drug studies of mania. Psychopharmacol Bull. 31:1995;103-109.
8. Bowden C.L., Davis J., Morris D., Swann A., Calabrese J., Lambert M., Goodnick P. Effect size efficacy measures comparing divalproex, lithium and placebo in acute mania. Depression Anxiety. 6:1997;26-30.
9. Calabrese J.R., Bowden C.L., Sachs G.S., Ascher J.A., Monaghan E., Rudd G.D., et al. A double-blind placebo-controlled study of lamotrigine monotherapy in outpatients with bipolar I depression. J Clin Psychiatry. 60:1999;79-88.
10. Calabrese J.R., Rapport D.J. Mood stabilizers and the evolution of maintenance study designs in bipolar I disorder. J Clin Psychiatry. 60:(suppl 5):1999;5-13.
11. Chambers C.A., Naylor G.J. A controlled trial of L-tryptophan in mania. Br J Psychiatry. 132:1978;555-559.
12. Chouinard G., Young S.N., Annable L. A controlled clinical trial of L-tryptophan in acute mania. Biol Psychiatry. 20:1982;546-557.
13. Cohen B.M., Lipinski J.F., Altesman R.I. Lecithin in the treatment of mania double-blind, placebo-controlled trials . Am J Psychiatry. 139:1982;1162-1164.
14. Cohen J. Statistical Power Analysis for the Behavioral Sciences. 2nd ed. 1988;Lawrence Erlbaum, Hillsdale, NJ.
15. Cohn J.B., Collins G., Ashbrook E., Wernicke J.F. A comparison of fluoxetine, imipramine and placebo in patients with bipolar depressive disorder. Int Clin Psychopharmacol. 4:1989;313-322.
16. Donnelly E.F., Goodwin F.K., Waldman I.N. Prediction of antidepressant responses to lithium. Psychiatr Res. 18:1978;309-320.
17. Dose M., Emrich H.M., Cording-Tömmel C., von Zerssen D. Use of calcium antagonists in mania. Psychoneuroendocrinology. 11:1986;241-243.
18. Dubovsky S.L., Franks R.D., Allen S., Murphy J. Calcium antagonists in mania A double-blind study of verapamil . Psychiatr Res. 18:1986;309-320.
19. Emrich H.M., v Zerssen D., Möller H.-J., Kissling W., Cording D., Schietsch H.J., et al. Action of propranolol in mania comparison of the effects of the d- and l-stereoisomer . Pharmakopsychiatrie. 12:1979;295-304.
20. Geller B., Cooper T.B., Sun K., Zimerman B., Frazier J., Williams M., et al. Double-blind and placebo-controlled study of lithium for adolescent bipolar disorders with secondary substance dependency. J Am Acad Child Adolesc Psychiatry. 37:1998;171-178.
21. Giannini A.J., Houser W.L. Jr, Loiselle R.H., Giannini M.L., Price W.A. Antimanic effects of verapamil. Am J Psychiatry. 141:1984;1602-1603.
22. Goodwin F.K., Murphy D.L., Bunney W.E. Jr. Lithium carbonate treatment in depression and mania. Arch Gen Psychiatry. 21:1969;486-496.
23. Goodwin F.K., Murphy D.L., Dunner D.L. Lithium response in unipolar versus bipolar depression. Am J Psychiatry. 129:1972;76-79.
24. Greenspan K., Schildkraut J.J., Gordon E.K. Catecholamine metabolism in affective disorders-III. J Psychiatr Res. 7:1970;171-182.
25. Himmelhoch J.M., Fuchs C.Z., Symons B.J. A double-blind study of tranylcypromine treatment of major anergic depression. J Nerv Ment Dis. 170:1982;628-634.
26. Janicak P.G., Sharma R.P., Easton M., Comaty J.E., Davis J.M. A double-blind, placebo-controlled trial of clonidine in the treatment of acute mania. Psychopharmacol Bull. 25:1989;243-245.
27. Janicak P.G., Sharma R.P., Pandey G., Davis J.M. Verapamil for the treatment of acute mania a double-blind, placebo-controlled trials . Am J Psychiatry. 155:1998;972-973.
28. Klein D.F. Importance of psychiatric diagnoses in prediction of clinical drug effects. Arch Gen Psychiatry. 16:1967;118-126.
29. Klerman G.L. Scientific and ethical considerations in the use of placebo controls in clinical trials in psychopharmacology. Psychopharmacol Bull. 22:1986;25-29.
30. Krieg J.C., Berger M. Treatment of mania with the cholinomimetic agent R86 (letter). Br J Psychiatr. 148:1986;613.
31. Leber P. The future of controlled clinical trials. Is there an alternative to the randomized controlled trial? Psychopharmacol Bull. 27:1991;3-8.
32. Leber P. Challenges to the ethicality of clinical research. Psychopharmacol Bull. 32:1996;11-13.
33. Levine J., Barak Y., Gonzalves M., Szor H., Elizur A., Kofman O., et al. Double-blind, controlled trial of inositol treatment of depression. Am J Psychiatry. 152:1995;792-794.
34. Maggs R. Treatment of manic illness with lithium carbonate. Br J Psychiatr. 109:1963;56-65.
35. Malone R.P., Simpson G.M. Use of placebos in clinical trials involving children and adolescents. Psychiatr Serv. 49:1998;1413-1414.
36. Mendels J. Lithium in the treatment of depression. Am J Psychiatry. 4:1976;373-378.
37. Nemeroff CB, Evans DL, Gyulai L, Sachs GS, Bowden CL, Gergel IP, et al (in press): A double-blind, placebo-controlled comparison of imipramine and paroxetine in the treatment of bipolar depression. Am J Psychiatry.
38. Noyes R., Dempsey G.M., Blum A. Lithium treatment of depression. Compr Psychiatry. 15:1974;187-193.
39. Pande A (1999, June): Adjunctive treatment with gabapentin for bipolar disorder. Paper presented at the Third International Conference on Bipolar Disorder, Pittsburgh.
40. Pope H.G. Jr, McElroy S.L., Keck P.E. Jr, Hudson J.I. Valproate in the treatment of acute mania. A placebo-controlled study. Arch Gen Psychiatry. 48:1991;62-68.
41. Quitkin F.M. Placebos, drug effects, and study design A clinician's guide . Am J Psychiatry. 156:1999;829-836.
42. Schou M., Juel-Nielson N., Strömgren E., Voldby H. The treatment of manic psychoses by the administration of lithium salts. J Neurol Neurosurg Psychiatry. 17:1954;250-260.
43. Stallone F., Mendlewicz J., Fieve R.R. How blind is the double-blind? An assessment in a lithium-prophylaxis study (letter) . Lancet. 1:1974;619-620.
44. Stanley B. An integration of ethical and clinical considerations in the use of placebos. Psychopharmacol Bull. 24:1988;18-20.
45. Stokes P.E., Stoll P.M., Shamoian C.A., Patton M.J. Efficacy of lithium as acute treatment of manic-depressive illness. Lancet. 1:1971;1319-1325.
46. Tohen M, Jacobs TG, Grundy SL, Banov MC, McElroy SL, Janicak PG, et al (1999a, May): A double-blind, placebo-controlled study of olanzapine in patients with acute bipolar mania. Paper presented at the annual meeting of the American Psychiatric Association, Washington, DC.
47. Tohen M., Sanger T.M., McElroy S.L., Tollefson G.D., Chengappa K.N.R., Daniel D.G., et al. Olanzapine versus placebo in the treatment of acute mania. Am J Psychiatry. 156:1999;702-709.
48. Van Berkestijn H., van der Meulen L.M.-H., Fletge F., Dols L., van den Hoofdakker R. RS 86 in manic disorder. Biol Psychiatry. 27:1990;109-112.
49. Zornberg G., Pope H.G. Jr. Treatment of depression in bipolar disorder New directions for research . J Clin Psychopharmacol. 13:1993;397-408.