A meta-analysis comparing open-label versus placebo-controlled clinical trials for aripiprazole augmentation in the treatment of major depressive disorder: Lessons and promises

Psychiatry Investigation

Volumn 11, Issue 4, 2014, Pages 371-379

  Pae, Chi Un ^a,b   Seo, Ho Jun ^a   Lee, Boung Chul ^c   Seok, Jeong Ho ^d   Jeon, Hong Jin ^e   Paik, Jong Woo ^f   Kwak, Kyung Phil ^g   Ham, Byung Joo ^h   Han, Changsu ^h   Lee, Soo Jung ^a  

^a The Catholic University of Korea College of Medicine   (South Korea)

^b DUKE UNIVERSITY MEDICAL CENTER   (United States)

^c Hallym University   (South Korea)

^d Yonsei University College of Medicine   (South Korea)

^e Sungkyunkwan University School of Medicine   (South Korea)

^f Kyung Hee University Hospital   (South Korea)

^g Dongguk University College of Medicine   (South Korea)

^h Korea University College of Medicine   (South Korea)

Author keywords

Aripiprazole; Augmentation; Depression; Open label study; Randomized controlled clinical trials

Indexed keywords

ARIPIPRAZOLE;

CONTROLLED CLINICAL TRIAL (TOPIC); DATA ANALYSIS; DATA EXTRACTION; EFFECT SIZE; HUMAN; LOGISTIC REGRESSION ANALYSIS; MAJOR DEPRESSION; META ANALYSIS; PUBLISHING; RANDOMIZED CONTROLLED TRIAL (TOPIC); REMISSION; REVIEW; SENSITIVITY ANALYSIS; STATISTICAL MODEL;

EID: 84928160578     PISSN: 17383684     EISSN: 19763026     Source Type: Journal    
DOI: 10.4306/pi.2014.11.4.371     Document Type: Review

References (41)

1. Egede LE. Major depression in individuals with chronic medical disorders: prevalence, correlates and association with health resource utilization, lost productivity and functional disability. Gen Hosp Psychiatry 2007;29:409-416.
2. Kessler RC, Berglund P, Demler O, Jin R, Koretz D, Merikangas KR, et al. The epidemiology of major depressive disorder: results from the National Comorbidity Survey Replication (NCS-R). JAMA 2003;289: 3095-3105.
3. Practice guideline for the treatment of patients with major depressive disorder (revision). American Psychiatric Association. Am J Psychiatry 2000;157(4 Suppl):1-45.
4. Thase ME. Are SNRIs more effective than SSRIs? A review of the current state of the controversy. Psychopharmacol Bull 2008;41:58-85.
5. Papakostas GI, Thase ME, Fava M, Nelson JC, Shelton RC. Are antidepressant drugs that combine serotonergic and noradrenergic mechanisms of action more effective than the selective serotonin reuptake inhibitors in treating major depressive disorder? A meta-analysis of studies of newer agents. Biol Psychiatry 2007;62:1217-1227.
6. Cipriani A, Furukawa TA, Salanti G, Geddes JR, Higgins JP, Churchill R, et al. Comparative efficacy and acceptability of 12 new-generation antidepressants: a multiple-treatments meta-analysis. Lancet 2009;373: 746-758.
7. Fava M, Rush AJ, Trivedi MH, Nierenberg AA, Thase ME, Sackeim HA, et al. Background and rationale for the sequenced treatment alternatives to relieve depression (STAR*D) study. Psychiatr Clin North Am 2003;26:457-494.
8. Trivedi MH, Rush AJ, Wisniewski SR, Nierenberg AA, Warden D, Ritz L, et al. Evaluation of outcomes with citalopram for depression using measurement-based care in STAR*D: implications for clinical practice. Am J Psychiatry 2006;163:28-40.
9. Nierenberg AA, Husain MM, Trivedi MH, Fava M, Warden D, Wisniewski SR, et al. Residual symptoms after remission of major depressive disorder with citalopram and risk of relapse: a STAR*D report. Psychol Med 2010;40:41-50.
10. Paykel ES, Ramana R, Cooper Z, Hayhurst H, Kerr J, Barocka A. Residual symptoms after partial remission: an important outcome in depression. Psychol Med 1995;25:1171-1180.
11. Thase ME. Evaluating antidepressant therapies: remission as the optimal outcome. J Clin Psychiatry 2003;64 Suppl 13:18-25.
12. Bauer M, Whybrow PC, Angst J, Versiani M, Moller HJ. World Federation of Societies of Biological Psychiatry (WFSBP) Guidelines for Biological Treatment of Unipolar Depressive Disorders, Part 1: Acute and continuation treatment of major depressive disorder. World J Biol Psychiatry 2002;3:5-43.
13. Anderson IM, Ferrier IN, Baldwin RC, Cowen PJ, Howard L, Lewis G, et al. Evidence-based guidelines for treating depressive disorders with antidepressants: a revision of the 2000 British Association for Psychopharmacology guidelines. J Psychopharmacol 2008;22:343-396.
14. Kennedy SH, Lam RW, Cohen NL, Ravindran AV; CANMAT Depression Work Group. Clinical guidelines for the treatment of depressive disorders. IV. Medications and other biological treatments. Can J Psychiatry 2001;46(Suppl 1):38S-58S.
15. Philip NS, Carpenter LL, Tyrka AR, Price LH. Augmentation of antidepressants with atypical antipsychotics: a review of the current literature. J Psychiatr Pract 2008;14:34-44.
16. Muller MJ, Szegedi A, Wetzel H, Benkert O. Moderate and severe depression. Gradations for the Montgomery-Asberg Depression Rating Scale. J Affect Disord 2000;60:137-140.
17. Baker WL, White CM, Cappelleri JC, Kluger J, Coleman CI; Health Outcomes, Policy, and Economics (HOPE) Collaborative Group. Understanding heterogeneity in meta-analysis: the role of meta-regression. Int J Clin Pract 2009;63:1426-1434.
18. Chen SJ, Hsiao YL, Shen TW, Chen ST. The effectiveness and safety of adjunctive aripiprazole in Taiwanese patients with antidepressant-refractory major depressive disorder: a prospective, open-label trial. J Clin Psychopharmacol 2012;32:56-60.
19. Fabrazzo M, Perris F, Monteleone P, Esposito G, Catapano F, Maj M. Aripiprazole augmentation strategy in clomipramine-resistant depressive patients: an open preliminary study. Eur Neuropsychopharmacol 2012;22:132-136.
20. Sheffrin M, Driscoll HC, Lenze EJ, Mulsant BH, Pollock BG, Miller MD, et al. Pilot study of augmentation with aripiprazole for incomplete response in late-life depression: getting to remission. J Clin Psychiatry 2009;70:208-213.
21. Matthews JD, Siefert C, Dording C, Denninger JW, Park L, van Nieuwenhuizen AO, et al. An open study of aripiprazole and escitalopram for psychotic major depressive disorder. J Clin Psychopharmacol 2009; 29:73-76.
22. Hellerstein DJ, Batchelder S, Hyler S, Arnaout B, Corpuz V, Coram L, et al. Aripiprazole as an adjunctive treatment for refractory unipolar depression. Prog Neuropsychopharmacol Biol Psychiatry 2008;32:744-750.
23. Schule C, Baghai TC, Eser D, Hecht S, Hermisson I, Born C, et al. Mirtazapine monotherapy versus combination therapy with mirtazapine and aripiprazole in depressed patients without psychotic features: a 4-week open-label parallel-group study. World J Biol Psychiatry 2007;8: 112-122.
24. Rutherford B, Sneed J, Miyazaki M, Eisenstadt R, Devanand D, Sackeim H, et al. An open trial of aripiprazole augmentation for SSRI non-remitters with late-life depression. Int J Geriatr Psychiatry 2007;22:986-991.
25. Patkar AA, Peindl K, Mago R, Mannelli P, Masand PS. An open-label, rater-blinded, augmentation study of aripiprazole in treatment-resistant depression. Prim Care Companion J Clin Psychiatry 2006;8:82-87.
26. Papakostas GI, Petersen TJ, Kinrys G, Burns AM, Worthington JJ, Alpert JE, et al. Aripiprazole augmentation of selective serotonin reuptake inhibitors for treatment-resistant major depressive disorder. J Clin Psychiatry 2005;66:1326-1330.
27. Simon JS, Nemeroff CB. Aripiprazole augmentation of antidepressants for the treatment of partially responding and nonresponding patients with major depressive disorder. J Clin Psychiatry 2005;66:1216-1220.
28. Nierenberg AA, Trivedi MH, Gaynes BN, Mitchell J, Davis LL, Husain MM, et al. Effectiveness Study of Venlafaxine-XR Combined with Aripiprazole for Chronic or Recurrent Major Depressive Disorder. Australian and New Zealand Journal of Psychiatry 2009;43:956-967.
29. Pae CU, Jeon HJ, Lee BC, Seo HJ, Kim SG, Park EJ, et al. Aripiprazole augmentation for treatment of patients with chronic or recurrent major depressive disorder: a 12-week prospective open-label multicentre study. Int Clin Psychopharmacol 2013;28:322-329.
30. Pae CU, Patkar AA, Jun TY, Lee C, Masand PS, Paik IH. Aripiprazole augmentation for treatment of patients with inadequate antidepressants response. Depress Anxiety 2007;24:522-526.
31. Berman RM, Marcus RN, Swanink R, McQuade RD, Carson WH, Corey- Lisle PK, et al. The efficacy and safety of aripiprazole as adjunctive therapy in major depressive disorder: a multicenter, randomized, double-blind, placebo-controlled study. J Clin Psychiatry 2007;68:843-853.
32. Berman RM, Fava M, Thase ME, Trivedi MH, Swanink R, McQuade RD, et al. Aripiprazole augmentation in major depressive disorder: a double-blind, placebo-controlled study in patients with inadequate response to antidepressants. CNS Spectr 2009;14:197-206.
33. Marcus RN, McQuade RD, Carson WH, Hennicken D, Fava M, Simon JS, et al. The efficacy and safety of aripiprazole as adjunctive therapy in major depressive disorder: a second multicenter, randomized, double-blind, placebo-controlled study. J Clin Psychopharmacol 2008;28:156-165.
34. Fava M, Mischoulon D, Iosifescu D, Witte J, Pencina M, Flynn M, et al. A double-blind, placebo-controlled study of aripiprazole adjunctive to antidepressant therapy among depressed outpatients with inadequate response to prior antidepressant therapy (ADAPT-A Study). Psychother Psychosom 2012;81:87-97.
35. Lin CH, Lin SH, Jang FL. Adjunctive low-dose aripiprazole with standard-dose sertraline in treating fresh major depressive disorder: a randomized, double-blind, controlled study. J Clin Psychopharmacol 2011; 31:563-568.
36. Mischoulon D, Witte J, Levy M, Papakostas GI, Pet LR, Hsieh WH, et al. Efficacy of dose increase among nonresponders to low-dose aripiprazole augmentation in patients with inadequate response to antidepressant treatment: a randomized, double-blind, placebo-controlled, efficacy trial. J Clin Psychiatry 2012;73:353-357.
37. Collaboration TC. 9.7 Sensitivity analyses In Cochrane Handbook for Systematic Reviews of Interventions. Ed by Higgins JPT and Green S accessed on August 30, 2013. Available at http://handbook.cochrane.org.
38. Biederman J, Petty CR, Woodworth KY, Lomedico A, O’Connor KB, Wozniak J, et al. How informative are open-label studies for youth with bipolar disorder? A meta-analysis comparing open-label versus randomized, placebo-controlled clinical trials. J Clin Psychiatry 2012; 73:358-365.
39. 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;73:1300-1306.
40. Iovieno N, Papakostas GI. Does the presence of an open-label antidepressant treatment period influence study outcome in clinical trials examining augmentation/combination strategies in treatment partial responders/nonresponders with major depressive disorder? J Clin Psychiatry 2012;73:676-683.
41. Marks DM, Pae CU. Innovations in clinical research design and conduct in psychiatry: shifting to pragmatic approaches. Psychiatry Investig 2009;6:1-6.