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A pooled analysis of six month comparative efficacy and tolerability in four randomized clinical trials: agomelatine versus escitalopram, fluoxetine, and sertraline

Published online by Cambridge University Press:  11 March 2013

Koen Demyttenaere ,
Emanuelle Corruble ,
Anthony Hale ,
Maria-Antonia Quera-Salva ,
Françoise Picarel-Blanchot  and
Siegfried Kasper
Koen Demyttenaere*
Affiliation:
Department of Psychiatry, University Psychiatric Center KU Leuven, Leuven, Belgium
Emanuelle Corruble
Affiliation:
Department of Psychiatry, INSERM U 669, Bicêtre University Hospital, Le Kremlin Bicêtre, France
Anthony Hale
Affiliation:
Department of Psychiatry, Trust Headquarters, St Martin's Hospital, Canterbury, Kent, UK
Maria-Antonia Quera-Salva
Affiliation:
Sleep Unit, Raymond Poincaré Hospital, Garches, APHP, France
Françoise Picarel-Blanchot
Affiliation:
IRIS, Suresnes, France
Siegfried Kasper
Affiliation:
Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria
*
*Address for correspondence: Koen Demyttenaere, University Psychiatric Centre University of Leuven, campus Gasthuisberg, Herestraat 49, 3000 Leuven, Belgium. (Email [email protected])
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Abstract

Objective

A pooled-analysis on the long-term outcome in four head-to-head studies: agomelatine versus fluoxetine, sertraline, and (twice) escitalopram.

Method

A meta-analytic approach was used. Hamilton Depression Rating Scale (HAM-D) scores, response and remission rates, Clinical Global Impression of Improvement (CGI-I) scores, response and remission rates, and completion rates/discontinuation rates due to adverse events were analyzed.

Results

At the last post-baseline assessment on the 24-week treatment period, the final HAM-D-17 score was significantly lower in patients treated with agomelatine than in patients treated with selective serotonin reuptake inhibitors (SSRIs), as well in the total group of patients with severe depression (P = 0.014 and 0.040, respectively). HAM-D response rates at the end of 24 weeks were significantly higher in patients treated with agomelatine than in patients treated with SSRIs, as well in the total group of patients with severe depression (P = 0.031 and 0.048, respectively). HAM-D remission rates at the end of 24 weeks were numerically but not significantly higher in patients treated with agomelatine than in patients treated with SSRIs. Final CGI-I scores were significantly lower for agomelatine. CGI-I response as well as remission rates were numerically higher in patients treated with agomelatine, without statistical significance. The percentage of patients with at least one emergent adverse event leading to treatment discontinuation was 9.4% in patients treated with SSRIs and 6.6% in patients treated with agomelatine (P = 0.065).

Conclusion

The present pooled analysis shows that, from a clinical point of view, agomelatine is at least as efficacious as the investigated SSRIs with a trend to fewer discontinuations due to adverse events.

Keywords

Antidepressantsagomelatineescitalopramfluoxetinesertraline
Type
Original Research
Information
CNS Spectrums , Volume 18 , Issue 3 , June 2013 , pp. 163 - 170
Copyright
Copyright © Cambridge University Press 2013 

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References

1.Papakostas, GI, Fava, M. Does the probability of receiving placebo influence clinical trial outcome? A meta-regression of double-blind, randomized clinical trials in MDD. Eur Neuropsychopharmacol. 2009; 19: 34–40.CrossRefGoogle ScholarPubMed
2.Moreno, SG, Sutton, AJ, Turner, EH, etal. Novel methods to deal with publication biases: secondary analysis of antidepressant trials in the FDA trial registry database and related journal publication. BMJ. 2009; 339: b2981.CrossRefGoogle Scholar
3.Kirsch, I, Deacon, BJ, Huedo-Medina, TB, Scoboria, A, Moore, TJ. Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration. PLoS Med. 2008; 5(2): 260–268.CrossRefGoogle ScholarPubMed
4.Fournier, JC, DeRubeis, RJ, Hollon, SD, etal. Antidepressant drug effects and depression severity: a patient-level meta-analysis. JAMA. 2010; 303(1): 47–53.CrossRefGoogle ScholarPubMed
5.Cuijpers, P, van Straten, A, Bohlmeijer, E, Hollon, SD, Andersson, G. The effects of psychotherapy for adult depression are overestimated: a meta-analysis of study quality and effect size. Psychol Med. 2010; 40(2): 211–223.CrossRefGoogle ScholarPubMed
6.Cuijpers, P, Smit, F, Bohlmeijer, E, Hollon, SD, Andersson, G. Efficacy of cognitive-behavioural therrapy and other psychological treatments for adult depression: meta-analytic study of publication bias. Br J Psychiatry. 2010; 196: 173–178.CrossRefGoogle Scholar
7.Zimmerman, M, Posternak, MA, Ruggero, CJ. Impact of study design on the results of continuation studies of antidepressants. J Clin Psychopharmacol. 2007; 27(2): 177–181.CrossRefGoogle ScholarPubMed
8.Bauer, M, Tharmanathan, P, Volz, HP, Moeller, HJ, Freemantle, N. The effect of venlafaxine compared with other antidepressants and placebo in the treatment of major depression: a meta-analysis. Eur Arch Psychiatry Clin Neurosci. 2009; 259: 172–185.CrossRefGoogle ScholarPubMed
9.Cipriani, A, Furukawa, TA, Salanti, G, etal. Comparative efficacy and acceptability of 12 new-generation antidepressants: a multiple-treatments meta-analysis. Lancet. 2009; 373: 746–758.CrossRefGoogle ScholarPubMed
10.Papakostas, GI, Thase, ME, Fava, M, Nelson, JC, Shelton, RC. Are antidepressant drugs that combine serotonergic and noraderenergic 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.CrossRefGoogle Scholar
11.Thase, ME, Ninan, PT, Musgnung, JJ, Trivedi, MH. Remission with venlafaxine extended release or selective serotonin reuptake inhibitors in depressed patients: a randomized, open-label study. Prim Care Companion CNS Disord. 2011; 13(1):PCC-10m00979.Google ScholarPubMed
12.Kennedy, SH, Rizvi, SJ. Agomelatine in the treatment of major depressive disorder. CNS Drugs. 2010; 24(6): 479–499.CrossRefGoogle ScholarPubMed
13.Hale, A, Corral, RM, Mencacci, C, etal. Superior antidepressant efficacy results of agomelatine versus fluoxetine in severe MDD patients: a randomized double-blind study. Int Clin Psychopharmacol. 2010; 25(6): 305–314.CrossRefGoogle ScholarPubMed
14.Kasper, S, Hajak, G, Wulff, K, etal. Efficacy of the novel antidepressant agomelatine on the circadian rest-activity cycle and depressive and anxiety symptoms in patients with major depressive disorder: a randomized double-blind comparison with sertraline. J Clin Psychiatry. 2010; 71(2): 109–120.CrossRefGoogle ScholarPubMed
15.Quera-Salva, MA, Hajak, G, Philip, P, etal. Comparison of agomelatine and escitalopram on nighttime sleep and daytime condition and efficacy in major depressive disorder patients. Int Clin Psychopharmacol. 2011; 26(5): 252–262.CrossRefGoogle ScholarPubMed
16.Corruble, E, Belaidi, C, Goodwin, G. Agomelatine versus escitalopram in major depressive disorders: a randomized double-blind, long term study focusing on sleep satisfaction and emotional blunting. Eur Psychiatry. 2011; 26(1): P02–P24.CrossRefGoogle Scholar
17.Montgomery, SA, Kasper, S. Severe depression and antidepressants: focus on a pooled analysis of placebo controlled studies on agomelatine. Int Clin Psychopharmacol. 2007; 22: 283–291.CrossRefGoogle ScholarPubMed
18.Sinyor, M, Levitt, AJ, Cheung, AH, etal. Does inclusion of a placebo arm influence response to active antidepressant treatment in randomized controlled trials? Results from pooled and meta-analyses. J Clin Psychiatry. 2010; 71(3): 270–279.CrossRefGoogle ScholarPubMed
19.Kennedy, SH, Andersen, HF, Thase, ME. Escitalopram in the treatment of major depressive disorder: a meta-analysis. Curr Med Res Opin. 2009; 25(1): 161–175.CrossRefGoogle ScholarPubMed
20.Zimmerman, M, Mattia, JI, Posternak, MA. Are subjects in pharmacological treatment trials of depression representative of patients in routine clinical practice? Am J Psychiatry. 2002; 159(3): 469–473.CrossRefGoogle ScholarPubMed
21.Demyttenaere, K, Verhaeghen, A, Dantchev, N, etal. “Caseness” for depression and anxiety in a depressed outpatient population: symptomatic outcome as a function of baseline diagnostic categories. Prim Care Companion J Clin Psychiatry. 2009; 11(6): 307–315.Google Scholar
22.Goethe, JW, Woolley, SB, Cardoni, AA, Woznicki, BA, Piez, DA. Selective serotonin reuptake inhibitor discontinuation: side effects and other factors that influence medication adherence. J Clin Psychopharmacol. 2007; 27(5): 451–458.CrossRefGoogle ScholarPubMed
23.Kennedy, SH, Rizvi, S, Fulton, K, Rasmussen, J. A double-blind comparison of sexual functioning, antidepressant efficacy, and tolerability between agomelatine and venlafaxine XR. J Clin Psychopharmacol. 2008; 28(3): 329–333.CrossRefGoogle ScholarPubMed
24.Montejo, AL, Prieto, N, Terleira, A, etal. Better sexual acceptability of agomelatine (25 and 50 mg) compared with paroxetine (20 mg) in healthy male volunteers: an 8-week, placebo controlled study using the PRSEXDQSALSEX scale. J Psychopharmacol. 2010; 24(1): 111–120.CrossRefGoogle ScholarPubMed