Predictors of placebo response in bipolar depression

International Clinical Psychopharmacology

Volumn 30, Issue 2, 2015, Pages 59-66

  Nierenberg, Andrew A ^a   Østergaard, Søren D ^b,c   Iovieno, Nadia ^a   Walker, Rosemary S W ^a   Fava, Maurizio ^a   Papakostas, George I ^a  

^a MASSACHUSETTS GENERAL HOSPITAL   (United States)

^b AARHUS UNIVERSITY HOSPITAL   (Denmark)

^c Lundbeck Foundation Initiative for Integrative Psychiatric Research   (Denmark)

Author keywords

bipolar depression; clinical trials; placebo response

Indexed keywords

PLACEBO; ANTIDEPRESSANT AGENT;

ARTICLE; BIPOLAR DEPRESSION; DISEASE SEVERITY; HUMAN; META ANALYSIS; MONOTHERAPY; OUTCOME ASSESSMENT; PLACEBO EFFECT; PRIORITY JOURNAL; PROBABILITY; RANDOMIZED CONTROLLED TRIAL (TOPIC); TREATMENT DURATION; BIPOLAR DISORDER;

ANTIDEPRESSIVE AGENTS; BIPOLAR DISORDER; HUMANS; PLACEBO EFFECT; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 84922404962     PISSN: 02681315     EISSN: 14735857     Source Type: Journal    
DOI: 10.1097/YIC.0000000000000058     Document Type: Article

References (49)

1. Agosti V, Stewart JW (2007). Efficacy and safety of antidepressant monotherapy in the treatment of bipolar-II depression. Int Clin Psychopharmacol 22:309-311.
2. American Psychiatric Association (1980). Diagnostic and Statistical Manual of Mental Disorders. 3rd ed Washington, DC: American Psychiatric Association.
3. American Psychiatric Association (1987). Diagnostic and Statistical Manual of Mental Disorders: DSM-III-R. Washington DC: American Psychiatric Association.
4. American Psychiatric Association (1994). Diagnostic and Statistical Manual of Mental Disorders. 4th Edition Washington, DC: American Psychiatric Association.
5. American Psychiatric Association (2002). Practice guideline for the treatment of patients with bipolar disorder (revision). Am J Psychiatry 159 (4 Suppl):1-50.
6. American Psychiatric Association (2013). Diagnostic and Statistical Manual of Mental Disorders. 5th ed. Washington, DC: American Psychiatric Association.
7. Brown ES, Garza M, Carmody TJ (2008). A randomized, double-blind, placebocontrolled add-on trial of quetiapine in outpatients with bipolar disorder and alcohol use disorders. J Clin Psychiatry 69:701-705.
8. Calabrese JR, Bowden CL, Sachs GS, Ascher JA, Monaghan E, Rudd GD (1999). A double-blind placebo-controlled study of lamotrigine monotherapy in outpatients with bipolar I depression. Lamictal 602 Study Group. J Clin Psychiatry 60:79-88.
9. Calabrese JR, Hirschfeld RM, Reed M, Davies MA, Frye MA, Keck PE, et al. (2003). Impact of bipolar disorder on a U.S. community sample. J Clin Psychiatry 64:425-432.
10. CalabreseJR, Keck PE Jr, Macfadden W, Minkwitz M, Ketter TA, Weisler RH, et al. (2005). A randomized, double-blind, placebo-controlled trial of quetiapine in the treatment of bipolar I or II depression. Am J Psychiatry 162:1351-1360.
11. Calabrese JR, Huffman RF,White RL, Edwards S, Thompson TR, Ascher JA, et al. (2008). Lamotrigine in the acute treatment of bipolar depression: results of five double-blind, placebo-controlled clinical trials. Bipolar Disord 10:323-333.
12. Carmody TJ, Rush AJ, Bernstein I, Warden D, Brannan S, Burnham D, et al. (2006). The Montgomery Asberg and the Hamilton ratings of depression: a comparison of measures. Eur Neuropsychopharmacol 16:601-611.
13. Cipriani A, Barbui C, Salanti G, Rendell J, Brown R, Stockton S, et al. (2011). Comparative efficacy and acceptability of antimanic drugs in acute mania: a multiple-treatments meta-analysis. Lancet 378:1306-1315.
14. Cohn JB, Collins G, Ashbrook E, Wernicke JF (1989). A comparison of fluoxetine imipramine and placebo in patients with bipolar depressive disorder. Int Clin Psychopharmacol 4:313-322.
15. DelBello MP, Chang K, Welge JA, Adler CM, Rana M, Howe M, et al. (2009). A double-blind, placebo-controlled pilot study of quetiapine for depressed adolescents with bipolar disorder. Bipolar Disord 11:483-493.
16. Fava M, Evins AE, Dorer DJ, Schoenfeld DA (2003). The problem of the placebo response in clinical trials for psychiatric disorders: culprits, possible remedies, and a novel study design approach. Psychother Psychosom 72:115-127.
17. Feighner JP, Robins E, Guze SB, Woodruff RA Jr, Winokur G, Munoz R (1972). Diagnostic criteria for use in psychiatric research. Arch Gen Psychiatry 26:57-63.
18. Geddes JR, Calabrese JR, Goodwin GM (2009). Lamotrigine for treatment of bipolar depression: independent meta-analysis and meta-regression of individual patient data from five randomised trials. Br J Psychiatry 194:4-9.
19. Ghaemi SN, Gilmer WS, Goldberg JF, Zablotsky B, Kemp DE, Kelley ME, et al. (2007). Divalproex in the treatment of acute bipolar depression: a preliminary double-blind, randomized, placebo-controlled pilot study. J Clin Psychiatry 68:1840-1844.
20. Goldberg JF, Harrow M (2011). A 15-year prospective follow-up of bipolar affective disorders: comparisons with unipolar nonpsychotic depression. Bipolar Disord 13:155-163.
21. Grunze H, Vieta E, Goodwin GM, Bowden C, Licht RW, Moller HJ, Kasper S (2009). The World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for the biological treatment of bipolar disorders: update 2009 on the treatment of acute mania. World J Biol Psychiatry 10:85-116.
22. Grunze H, Vieta E, Goodwin GM, Bowden C, Licht RW, Möller HJ, Kasper S. WFSBP Task Force on Treatment Guidelines for Bipolar Disorders (2013). The World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for the biological treatment of bipolar disorders: update 2012 on the long-term treatment of bipolar disorder. World J Biol Psychiatry 14:154-219.
23. Hamilton M (1960). A rating scale for depression. J Neurol Neurosurg Psychiatry 23:56-62.
24. Himmelhoch JM, Fuchs CZ, Symons BJ (1982). A double-blind study of tranylcypromine treatment of major anergic depression. J Nerv Ment Dis 170:628-634.
25. Iovieno N, Papakostas GI (2012). Correlation between different levels of placebo response rate and clinical trial outcome in major depressive disorder: a metaanalysis. J Clin Psychiatry 73:1300-1306.
26. Judd LL, Akiskal HS, Schettler PJ, Endicott J, Maser J, Solomon DA, et al. (2002). The long-term natural history of the weekly symptomatic status of bipolar I disorder. Arch Gen Psychiatry 59:530-537.
27. Judd LL, Akiskal HS, Schettler PJ, Endicott J, Leon AC, Solomon DA, et al. (2005). Psychosocial disability in the course of bipolar I and II disorders: a prospective, comparative, longitudinal study. Arch Gen Psychiatry 62:1322-1330.
28. Kanba S, Kawasaki H, Ishigooka J, Sakamoto K, Kinoshita T, Kuroki T (2014). A placebo-controlled, double-blind study of the efficacy and safety of aripiprazole for the treatment of acute manic or mixed episodes in Asian patients with bipolar I disorder (the AMAZE study). World J Biol Psychiatry 15:113-121.
29. Kupka RW, Altshuler LL, Nolen WA, Suppes T, Luckenbaugh DA, Leverich GS, et al. (2007). Three times more days depressed than manic or hypomanic in both bipolar I and bipolar II disorder. Bipolar Disord 9:531-535.
30. Loebel A, Cucchiaro J, Silva R, Sarma K, Kroger H, Calabrese J, et al. (2012). Lurasidone monotherapy for the treatment of bipolar I depression: results of the 6-week, double-blind, placebo-controlled study (PREVAIL-2). Philadelphia, PA: Poster presented at the 165th Annual Meeting of the American Psychiatric Association 2012; .
31. Loebel A, Cucchiaro J, Silva R, Kroger H, Sarma K, Xu J, Calabrese JR (2014). Lurasidone as adjunctive therapy with lithium or valproate for the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study. Am J Psychiatry 171:169-177.
32. McElroy SL, Weisler RH, Chang W, Olausson B, Paulsson B, Brecher M, et al. EMBOLDEN II (Trial D1447C00134) Investigators (2010). A double-blind, placebo-controlled study of quetiapine and paroxetine as monotherapy in adults with bipolar depression (EMBOLDEN II). J Clin Psychiatry 71:163-174.
33. Montgomery SA, Asberg M (1979). A new depression scale designed to be sensitive to change. Br J Psychiatry 134:382-389.
34. Muzina DJ, Gao K, Kemp DE, Khalife S, Ganocy SJ, Chan PK, et al. (2011). Acute efficacy of divalproex sodium versus placebo in mood stabilizer-naive bipolar I or II depression: a double-blind, randomized, placebo-controlled trial. J Clin Psychiatry 72:813-819.
35. Papakostas GI, Fava M (2009). Does the probability of receiving placebo influence clinical trial outcome? A meta-regression of double-blind, randomized clinical trials in MDD. Eur Neuropsychopharmacol 19:34-40.
36. Sachs GS, Ice KS, Chappell PB, Schwartz JH, Gurtovaya O, Vanderburg DG, Kasuba B (2011). Efficacy and safety of adjunctive oral ziprasidone for acute treatment of depression in patients with bipolar I disorder: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry 72:1413-1422.
37. Solomon DA, Leon AC, Coryell WH, Endicott J, Li C, Fiedorowicz JG, et al. (2010). Longitudinal course of bipolar I disorder: duration of mood episodes. Arch Gen Psychiatry 67:339-347.
38. Spitzer RL, Endicott J, Robins E (1978). Research diagnostic criteria: rationale and reliability. Arch Gen Psychiatry 35:773-782.
39. Suppes T, Datto C, Minkwitz M, Nordenhem A, Walker C, Darko D (2010). Effectiveness of the extended release formulation of quetiapine as monotherapy for the treatment of acute bipolar depression. J Affect Disord 121:106-115.
40. Tedeschini E, Fava M, Papakostas GI (2011). Placebo-controlled, antidepressant clinical trials cannot be shortened to less than 4 weeks' duration: a pooled analysis of randomized clinical trials employing a diagnostic odds ratio-based approach. J Clin Psychiatry 72:98-113.
41. Thase ME, Macfadden W, Weisler RH, Chang W, Paulsson B, Khan A, Calabrese JR. BOLDER II Study Group (2006). Efficacy of quetiapine monotherapy in bipolar I and II depression: a double-blind, placebo-controlled study (the BOLDER II study). J Clin Psychopharmacol 26:600-609.
42. Thase ME, Jonas A, Khan A, Bowden CL, Wu X, McQuade RD, et al. (2008). Aripiprazole monotherapy in nonpsychotic bipolar I depression: results of 2 randomized, placebo-controlled studies. J Clin Psychopharmacol 28:13-20.
43. Tohen M, Vieta E, Calabrese J, Ketter TA, Sachs G, Bowden C, et al. (2003). Efficacy of olanzapine and olanzapine-fluoxetine combination in the treatment of bipolar I depression. Arch Gen Psychiatry 60:1079-1088.
44. Tohen M, McDonnell DP, Case M, Kanba S, Ha K, Fang YR, et al. (2012). Randomised, double-blind, placebo-controlled study of olanzapine in patients with bipolar I depression. Br J Psychiatry 201:376-382.
45. Vieta E, Valentí M (2013). Pharmacological management of bipolar depression: acute treatment, maintenance, and prophylaxis. CNS Drugs 27:515-529.
46. Vieta E, Locklear J, Günther O, Ekman M, Miltenburger C, Chatterton ML, et al. (2010). Treatment options for bipolar depression: a systematic review of randomized, controlled trials. J Clin Psychopharmacol 30:579-590.
47. Yildiz A, Vieta E, Leucht S, Baldessarini RJ (2011). Efficacy of antimanic treatments: meta-analysis of randomized, controlled trials. Neuropsychopharmacology 36:375-389.
48. Young AH, McElroy SL, Bauer M, Philips N, Chang W, Olausson B, et al. EMBOLDEN I (Trial 001) Investigators (2010). A double-blind, placebocontrolled study of quetiapine and lithium monotherapy in adults in the acute phase of bipolar depression (EMBOLDEN I). J Clin Psychiatry 71:150-162.
49. Young AH, McElroy SL, Olausson B, Paulsson B. Embolden I (D1447C00001); Embolden II (D1447C00134) Investigators (2014). A randomised, placebocontrolled 52-week trial of continued quetiapine treatment in recently depressed patients with bipolar I and bipolar II disorder. World J Biol Psychiatry 15:96-112q.