Agomelatine or placebo as adjunctive therapy to a mood stabiliser in bipolar I depression: Randomised double-Blind placebo-Controlled trial

British Journal of Psychiatry

Volumn 208, Issue 1, 2016, Pages 78-86

  Yatham, Lakshmi N ^a   Vieta, Eduard ^b   Goodwin, Guy M ^c   Bourin, Michel ^d   De Bodinat, Christian ^e   Laredo, Judith ^e   Calabrese, Joseph ^f  

^a UNIVERSITY OF BRITISH COLUMBIA   (Canada)

^b UNIVERSITY OF BARCELONA   (Spain)

^c UNIVERSITY OF OXFORD   (United Kingdom)

^d UNIVERSITÉ DE NANTES   (France)

^e IRIS Institut de Recherches Internationales Servier   (France)

^f CASE WESTERN RESERVE UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AGOMELATINE; LITHIUM; PLACEBO; VALPROIC ACID; ACETAMIDE DERIVATIVE; ANTIDEPRESSANT AGENT; LITHIUM DERIVATIVE; TRANQUILIZER;

ADJUVANT THERAPY; ADULT; AGED; ARTICLE; BIPOLAR I DISORDER; CLINICAL EFFECTIVENESS; CONTROLLED STUDY; DEPRESSION; DIARRHEA; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; HEADACHE; HUMAN; HYPOMANIA; INSOMNIA; MAJOR CLINICAL STUDY; MAJOR DEPRESSION; MALE; MANIA; MIXED MANIA AND DEPRESSION; MONTGOMERY ASBERG DEPRESSION RATING SCALE; MOOD; MULTICENTER STUDY; PLACEBO EFFECT; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SOMNOLENCE; ARGENTINA; AUSTRALIA; BIPOLAR DISORDER; BRAZIL; CANADA; CLINICAL TRIAL; COMBINATION DRUG THERAPY; EUROPE; INDIA; INTERNATIONAL COOPERATION; MIDDLE AGED; PSYCHOLOGICAL RATING SCALE; SOUTH AFRICA; SOUTH KOREA; TREATMENT OUTCOME;

ACETAMIDES; ADULT; ANTIDEPRESSIVE AGENTS; ANTIMANIC AGENTS; ARGENTINA; AUSTRALIA; BIPOLAR DISORDER; BRAZIL; CANADA; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; EUROPE; FEMALE; HUMANS; INDIA; INTERNATIONAL COOPERATION; LITHIUM COMPOUNDS; MALE; MIDDLE AGED; PLACEBO EFFECT; PSYCHIATRIC STATUS RATING SCALES; REPUBLIC OF KOREA; SOUTH AFRICA; TREATMENT OUTCOME; VALPROIC ACID;

EID: 84956612115     PISSN: 00071250     EISSN: 14721465     Source Type: Journal    
DOI: 10.1192/bjp.bp.114.147587     Document Type: Article

References (45)

1. Hlastala SA, Frank E, Mallinger AG, Thase ME, Ritenour AM, Kupfer DJ. Bipolar depression: An underestimated treatment challenge. Depress Anxiety 1997; 5: 73-83.
2. Judd LL, Akiskal HS, Schettler PJ, Endicott J, Maser J, Solomon DA, et al. The long-term natural history of the weekly symptomatic status of bipolar I disorder. Arch Gen Psychiatry 2002; 59: 530-7.
3. Kupka RW, Altshuler LL, Nolen WA, Suppes T, Luckenbaugh DA, Leverich GS, et al. Three times more days depressed than manic or hypomanic in both bipolar I and bipolar II disorder. Bipolar Disord 2007; 9: 531-5.
4. Kauer-Sant'Anna M, Bond DJ, Lam RW, Yatham LN. Functional outcomes in first-episode patients with bipolar disorder: A prospective study from the Systematic Treatment Optimization Program for Early Mania project. Compr Psychiatry 2009; 50: 1-8.
5. Yatham LN, Lecrubier Y, Fieve RR, Davis KH, Harris SD, Krishnan AA. Quality of life in patients with bipolar I depression: Data from 920 patients. Bipolar Disord 2004; 6: 379-85.
6. Angst J, Hengartner MP, Gamma A, von ZD, Angst F. Mortality of 403 patients with mood disorders 48 to 52 years after their psychiatric hospitalisation. Eur Arch Psychiatry Clin Neurosci 2013; 263: 425-34.
7. Osby U, Brandt L, Correia N, Ekbom A, Sparen P. Excess mortality in bipolar and unipolar disorder in Sweden. Arch Gen Psychiatry 2001; 58: 844-850.
8. Baldessarini RJ, Leahy L, Arcona S, Gause D, Zhang W, Hennen J. Patterns of psychotropic drug prescription for U.S. patients with diagnoses of bipolar disorders. Psychiatr Serv 2007; 58: 85-91.
9. Vieta E, Langosch JM, Figueira ML, Souery D, Blasco-Colmenares E, Medina E, et al. Clinical management and burden of bipolar disorder: Results from a multinational longitudinal study (WAVE-bd). Int J Neuropsychopharmacol 2013; 16: 1719-32.
10. Pacchiarotti I, Bond DJ, Baldessarini RJ, Nolen WA, Grunze H, Licht RW, et al. The International Society for Bipolar Disorders (ISBD) Task Force Report on antidepressant use in bipolar disorders. Am J Psychiatry 2013; 170: 1249-62.
11. Tohen M, Vieta E, Calabrese J, Ketter TA, Sachs G, Bowden C, et al. Efficacy of olanzapine and olanzapine-fluoxetine combination in the treatment of bipolar I depression. Arch Gen Psychiatry 2003; 60: 1079-88.
12. Nemeroff CB, Evans DL, Gyulai L, Sachs GS, Bowden CL, Gergel IP, et al. Double-blind, placebo-controlled comparison of imipramine and paroxetine in the treatment of bipolar depression. Am J Psychiatry 2001; 158: 906-12.
13. Sachs GS, Nierenberg AA, Calabrese JR, Marangell LB, Wisniewski SR, Gyulai L, et al. Effectiveness of adjunctive antidepressant treatment for bipolar depression. New Engl J Med 2007; 356: 1711-22.
14. Vieta E, Cruz N. Head to head comparisons as an alternative to placebocontrolled trials. Eur Neuropsychopharmacol 2012; 22: 800-3.
15. Merlo-Pich E, Alexander RC, Fava M, Gomeni R. A new populationenrichment strategy to improve efficiency of placebo-controlled clinical trials of antidepressant drugs. Clin Pharmacol Ther 2010; 88: 634-42.
16. Dunlop BW, Thase ME, Wun CC, Fayyad R, Guico-Pabia CJ, Musgnung J, et al. A meta-analysis of factors impacting detection of antidepressant efficacy in clinical trials: The importance of academic sites. Neuropsychopharmacol 2012; 37: 2830-6.
17. Vieta E, Locklear J, Gunther O, Ekman M, Miltenburger C, Chatterton ML, et al. Treatment options for bipolar depression: A systematic review of randomized, controlled trials. J Clin Psychopharmacol 2010; 30: 579-90.
18. de BC, Guardiola-Lemaitre B, Mocaer E, Renard P, Munoz C, Millan MJ. Agomelatine, the first melatonergic antidepressant: Discovery, characterization and development. Nat Rev Drug Discov 2010; 9: 628-42.
19. Hickie IB, Rogers NL. Novel melatonin-based therapies: potential advances in the treatment of major depression. Lancet 2011; 378: 621-31.
20. Goodwin GM, Emsley R, Rembry S, Rouillon F. Agomelatine prevents relapse in patients with major depressive disorder without evidence of a discontinuation syndrome: A 24-week randomized, double-blind, placebocontrolled trial. J Clin Psychiatry 2009; 70: 1128-37.
21. Goodwin GM, Boyer P, Emsley R, Rouillon F, de BC. Is it time to shift to better characterization of patients in trials assessing novel antidepressants? An example of two relapse prevention studies with agomelatine. Int Clin Psychopharmacol 2013; 28: 20-8.
22. Stein DJ, Ahokas AA, de BC. Efficacy of agomelatine in generalized anxiety disorder: A randomized, double-blind, placebo-controlled study. J Clin Psychopharmacol 2008; 28: 561-6.
23. Stein DJ, Ahokas A, Albarran C, Olivier V, Allgulander C. Agomelatine prevents relapse in generalized anxiety disorder: A 6-month randomized, double-blind, placebo-controlled discontinuation study. J Clin Psychiatry 2012; 73: 1002-8.
24. Kasper S, Corruble E, Hale A, Lemoine P, Montgomery SA, Quera-Salva MA. Antidepressant efficacy of agomelatine versus SSRI/SNRI: Results from a pooled analysis of head-to-head studies without a placebo control. Int Clin Psychopharmacol 2013; 28: 12-9.
25. Calabrese JR, Guelfi JD, Perdrizet-Chevallier C. Agomelatine adjunctive therapy for acute bipolar depression: preliminary open data. Bipolar Disord 2007; 9: 628-35.
26. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders (4th edn, revised) (DSM-IV-TR). APA, 2000.
27. Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, et al. The Mini-International Neuropsychiatric Interview (M.I.N.I.): The development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry 1998; 59 (suppl 20): 22-33.
28. Hamilton M. A rating scale for depression. J Neurol Neurosurg Psychiatry 1960; 23: 56-62.
29. Young RC, Biggs JT, Ziegler VE, Meyer DA. A rating scale for mania: Reliability, validity and sensitivity. Br J Psychiatry 1978; 133: 429-35.
30. Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry 1979; 134: 382-9.
31. Vieta Pascual E, Torrent Font C, Martínez-Ará n A, Colom Victoriano F, Reinares Gabnepen M, Benabarre Herná ndez A, et al. A user-friendly scale for the short and long term outcomes of bipolar disorder: The CGI-BP-M [in Spanish]. Actas Espa Psiqiatr 2002; 30: 301-4.
32. Hamilton M. The assessment of anxiety states by rating. Br J Med Psychol 1959; 32: 50-5.
33. Parrott AC, Hindmarch I. Factor analysis of a sleep evaluation questionnaire. Psychol Med 1978; 8: 325-9.
34. Endicott J, Nee J, Harrison W, Blumenthal R. Quality of Life Enjoyment and Satisfaction Questionnaire: A new measure. Psychopharmacol Bull 1993; 29: 321-6.
35. van der Loos ML, Mulder PG, Hartong EG, Blom MB, Vergouwen AC, de Keyzer HJ, et al. Efficacy and safety of lamotrigine as add-on treatment to lithium in bipolar depression: A multicenter, double-blind, placebo-controlled trial. J Clin Psychiatry 2009; 70: 223-31.
36. Loebel A, Cucchiaro J, Silva R, Kroger H, Sarma K, Xu J, et al. 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 2014; 171: 169-77.
37. Walsh BT, Seidman SN, Sysko R, Gould M. Placebo response in studies of major depression: variable, substantial, and growing. JAMA 2002; 287: 1840-7.
38. Calabrese JR, Bowden CL, Sachs GS, Ascher JA, Monaghan E, Rudd GD. A double-blind placebo-controlled study of lamotrigine monotherapy in outpatients with bipolar I depression. Lamictal 602 Study Group. J Clin Psychiatry 1999; 60: 79-88.
39. Young AH, McElroy SL, Bauer M, Philips N, Chang W, Olausson B, et al. A double-blind, placebo-controlled study of quetiapine and lithium monotherapy in adults in the acute phase of bipolar depression (EMBOLDEN I). J Clin Psychiatry 2010; 71: 150-62.
40. Sachs GS, Ice KS, Chappell PB, Schwartz JH, Gurtovaya O, Vanderburg DG, et al. 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 2011; 72: 1413-22.
41. Lombardo I, Sachs G, Kolluri S, Kremer C, Yang R. Two 6-week, randomized, double-blind, placebo-controlled studies of ziprasidone in outpatients with bipolar I depression: Did baseline characteristics impact trial outcome? J Clin Psychopharmacol 2012; 32: 470-8.
42. Zimmerman M, Posternak MA, Chelminski I. Derivation of a definition of remission on the Montgomery-Asberg depression rating scale corresponding to the definition of remission on the Hamilton rating scale for depression. J Psychiatr Res 2004; 38: 577-82.
43. Iovieno N, Papakostas GI. Correlation between different levels of placebo response rate and clinical trial outcome in major depressive disorder: A meta-analysis. J Clin Psychiatry 2012; 73: 1300-6.
44. Gijsman HJ, Geddes JR, Rendell JM, Nolen WA, Goodwin GM. Antidepressants for bipolar depression: A systematic review of randomized, controlled trials. Am J Psychiatry 2004; 161: 1537-47.
45. Valenti M, Pacchiarotti I, Bonnin CM, Rosa AR, Popovic D, Nivoli AM, et al. Risk factors for antidepressant-related switch to mania. J Clin Psychiatry 2012; 73: E271-6.