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Superior antidepressant efficacy results of agomelatine versus fluoxetine in severe MDD patients: a randomized, double-blind study.
Int Clin Psychopharmacol. 2010 Nov; 25(6):305-14.IC

Abstract

The objective of this international, 8-week, randomized, double-blind study was to show the superiority of the antidepressant efficacy of agomelatine, the first MT1/MT2 receptor agonist and 5-HT2C receptor antagonist antidepressant, versus fluoxetine in outpatients fulfilling Diagnostic and Statistical Manual of Mental Disorders-volume IV-TR criteria for major depressive disorder of severe intensity, defined by a baseline Hamilton Depression Rating Scale (HAM-D17) total score of at least 25 and CGI severity of illness score of at least 4. Patients received agomelatine 25-50 mg/day (n=252) or fluoxetine 20-40 mg/day (n=263) for 8 weeks. The main efficacy outcome measure was HAM-D17 total score (change from baseline to last post-baseline assessment). Secondary outcome measures were Clinical Global Impressions-improvement (CGI), severity (CGI-S), anxiety (HAM-A), and sleep (HAM-D sleep items) scores. The mean decrease in HAM-D17 total score over 8 weeks was significantly greater with agomelatine than fluoxetine with a between-group difference of 1.49 (95% confidence interval, 0.20-2.77; P=0.024). The percentage of responders at last post-baseline assessment was higher with agomelatine on both HAM-D17 (decrease in total score from baseline ≥50%; 71.7% agomelatine vs. 63.8% fluoxetine; P=0.060) and CGI-improvement (score 1 or 2; 77.7 vs. 68.8%; P=0.023). There was a significant between-group difference of 0.37 (95% confidence interval, 0.06-0.68) in HAM-D sleep subscore in favor of agomelatine (P=0.018). Similar improvements were observed on HAM-A with agomelatine and fluoxetine. Both treatments were safe and well tolerated. In conclusion, in this study, agomelatine showed superior antidepressant efficacy over fluoxetine in treating patients with a severe episode of major depressive disorder after 8 weeks of treatment with a good tolerability profile.

Authors+Show Affiliations

Trust Headquarters, St Martin's Hospital, Canterbury, UK. ash25@kent.ac.ukNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20856123

Citation

Hale, Anthony, et al. "Superior Antidepressant Efficacy Results of Agomelatine Versus Fluoxetine in Severe MDD Patients: a Randomized, Double-blind Study." International Clinical Psychopharmacology, vol. 25, no. 6, 2010, pp. 305-14.
Hale A, Corral RM, Mencacci C, et al. Superior antidepressant efficacy results of agomelatine versus fluoxetine in severe MDD patients: a randomized, double-blind study. Int Clin Psychopharmacol. 2010;25(6):305-14.
Hale, A., Corral, R. M., Mencacci, C., Ruiz, J. S., Severo, C. A., & Gentil, V. (2010). Superior antidepressant efficacy results of agomelatine versus fluoxetine in severe MDD patients: a randomized, double-blind study. International Clinical Psychopharmacology, 25(6), 305-14. https://doi.org/10.1097/YIC.0b013e32833a86aa
Hale A, et al. Superior Antidepressant Efficacy Results of Agomelatine Versus Fluoxetine in Severe MDD Patients: a Randomized, Double-blind Study. Int Clin Psychopharmacol. 2010;25(6):305-14. PubMed PMID: 20856123.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Superior antidepressant efficacy results of agomelatine versus fluoxetine in severe MDD patients: a randomized, double-blind study. AU - Hale,Anthony, AU - Corral,Ricardo-Marcelo, AU - Mencacci,Claudio, AU - Ruiz,Jeronimo Saiz, AU - Severo,Cristina Albarran, AU - Gentil,Valentim, PY - 2010/9/22/entrez PY - 2010/9/22/pubmed PY - 2011/2/1/medline SP - 305 EP - 14 JF - International clinical psychopharmacology JO - Int Clin Psychopharmacol VL - 25 IS - 6 N2 - The objective of this international, 8-week, randomized, double-blind study was to show the superiority of the antidepressant efficacy of agomelatine, the first MT1/MT2 receptor agonist and 5-HT2C receptor antagonist antidepressant, versus fluoxetine in outpatients fulfilling Diagnostic and Statistical Manual of Mental Disorders-volume IV-TR criteria for major depressive disorder of severe intensity, defined by a baseline Hamilton Depression Rating Scale (HAM-D17) total score of at least 25 and CGI severity of illness score of at least 4. Patients received agomelatine 25-50 mg/day (n=252) or fluoxetine 20-40 mg/day (n=263) for 8 weeks. The main efficacy outcome measure was HAM-D17 total score (change from baseline to last post-baseline assessment). Secondary outcome measures were Clinical Global Impressions-improvement (CGI), severity (CGI-S), anxiety (HAM-A), and sleep (HAM-D sleep items) scores. The mean decrease in HAM-D17 total score over 8 weeks was significantly greater with agomelatine than fluoxetine with a between-group difference of 1.49 (95% confidence interval, 0.20-2.77; P=0.024). The percentage of responders at last post-baseline assessment was higher with agomelatine on both HAM-D17 (decrease in total score from baseline ≥50%; 71.7% agomelatine vs. 63.8% fluoxetine; P=0.060) and CGI-improvement (score 1 or 2; 77.7 vs. 68.8%; P=0.023). There was a significant between-group difference of 0.37 (95% confidence interval, 0.06-0.68) in HAM-D sleep subscore in favor of agomelatine (P=0.018). Similar improvements were observed on HAM-A with agomelatine and fluoxetine. Both treatments were safe and well tolerated. In conclusion, in this study, agomelatine showed superior antidepressant efficacy over fluoxetine in treating patients with a severe episode of major depressive disorder after 8 weeks of treatment with a good tolerability profile. SN - 1473-5857 UR - https://www.unboundmedicine.com/medline/citation/20856123/Superior_antidepressant_efficacy_results_of_agomelatine_versus_fluoxetine_in_severe_MDD_patients:_a_randomized_double_blind_study_ L2 - http://dx.doi.org/10.1097/YIC.0b013e32833a86aa DB - PRIME DP - Unbound Medicine ER -