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Efficacy and safety of levomilnacipran sustained release 40 mg, 80 mg, or 120 mg in major depressive disorder: a phase 3, randomized, double-blind, placebo-controlled study.
J Clin Psychiatry 2013; 74(3):242-8JC

Abstract

OBJECTIVE

This phase 3, randomized, double-blind, placebo-controlled study evaluated the efficacy and tolerability of fixed-dose levomilnacipran sustained release (SR) compared with placebo in patients with major depressive disorder (MDD); the study was conducted from September 2009-May 2011.

METHOD

Outpatients met DSM-IV-TR criteria for MDD with an ongoing major depressive episode ≥ 8 weeks' duration. After a 1-week placebo lead-in, patients were randomly assigned to receive placebo (n = 179) or levomilnacipran SR 40 mg (n = 181), 80 mg (n = 181), or 120 mg (n = 183) once daily for 8 weeks of double-blind treatment, followed by a 2-week double-blind down-taper. The primary efficacy parameter was change from baseline on the clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) total score. The prespecified secondary efficacy parameter was change from baseline in Sheehan Disability Scale (SDS) total score. Additional efficacy measures included the 17-item Hamilton Depression Rating Scale (HDRS(17)) and Clinical Global Impressions-Severity of Illness (CGI-S) and -Improvement (CGI-I). Safety and tolerability were also evaluated.

RESULTS

The least squares mean difference (LSMD) for change from baseline in MADRS total score was significantly superior to placebo for all dose groups: -3.23 (P = .0186), -3.99 (P = .0038), and -4.86 (P = .0005) for levomilnacipran SR 40, 80, and 120 mg, respectively. The LSMD was significantly different for levomilnacipran SR 80 mg and 120 mg versus placebo on the SDS (-2.51 and -2.57, respectively, P < .05 for both doses), HDRS(17) (-2.09 and -2.34, respectively, P < .05 for both doses), CGI-S (-0.43 [P < .01] and -0.35 [P < .05], respectively), and CGI-I (-0.34 and -0.32, respectively, P < .05 for both doses) assessments. The most common treatment-emergent adverse events (≥ 10% of any treatment group) were headache, nausea, constipation, dry mouth, increased heart rate, and hyperhidrosis.

CONCLUSIONS

Levomilnacipran SR demonstrated significant improvement in depressive symptoms and functioning relative to placebo. In this study, levomilnacipran SR was generally well tolerated.

TRIAL REGISTRATION

ClinicalTrials.gov identifier: NCT00969709.

Authors+Show Affiliations

Department of Psychiatry and Behavioral Sciences, Albert Einstein College of Medicine, Montefiore Medical Center, 111 East 210th St, Bronx, NY 10467, USA. asnisarts@aol.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23561229

Citation

Asnis, Gregory M., et al. "Efficacy and Safety of Levomilnacipran Sustained Release 40 Mg, 80 Mg, or 120 Mg in Major Depressive Disorder: a Phase 3, Randomized, Double-blind, Placebo-controlled Study." The Journal of Clinical Psychiatry, vol. 74, no. 3, 2013, pp. 242-8.
Asnis GM, Bose A, Gommoll CP, et al. Efficacy and safety of levomilnacipran sustained release 40 mg, 80 mg, or 120 mg in major depressive disorder: a phase 3, randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2013;74(3):242-8.
Asnis, G. M., Bose, A., Gommoll, C. P., Chen, C., & Greenberg, W. M. (2013). Efficacy and safety of levomilnacipran sustained release 40 mg, 80 mg, or 120 mg in major depressive disorder: a phase 3, randomized, double-blind, placebo-controlled study. The Journal of Clinical Psychiatry, 74(3), pp. 242-8. doi:10.4088/JCP.12m08197.
Asnis GM, et al. Efficacy and Safety of Levomilnacipran Sustained Release 40 Mg, 80 Mg, or 120 Mg in Major Depressive Disorder: a Phase 3, Randomized, Double-blind, Placebo-controlled Study. J Clin Psychiatry. 2013;74(3):242-8. PubMed PMID: 23561229.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of levomilnacipran sustained release 40 mg, 80 mg, or 120 mg in major depressive disorder: a phase 3, randomized, double-blind, placebo-controlled study. AU - Asnis,Gregory M, AU - Bose,Anjana, AU - Gommoll,Carl P, AU - Chen,Changzheng, AU - Greenberg,William M, PY - 2012/09/28/received PY - 2013/01/28/accepted PY - 2013/4/9/entrez PY - 2013/4/9/pubmed PY - 2013/6/1/medline SP - 242 EP - 8 JF - The Journal of clinical psychiatry JO - J Clin Psychiatry VL - 74 IS - 3 N2 - OBJECTIVE: This phase 3, randomized, double-blind, placebo-controlled study evaluated the efficacy and tolerability of fixed-dose levomilnacipran sustained release (SR) compared with placebo in patients with major depressive disorder (MDD); the study was conducted from September 2009-May 2011. METHOD: Outpatients met DSM-IV-TR criteria for MDD with an ongoing major depressive episode ≥ 8 weeks' duration. After a 1-week placebo lead-in, patients were randomly assigned to receive placebo (n = 179) or levomilnacipran SR 40 mg (n = 181), 80 mg (n = 181), or 120 mg (n = 183) once daily for 8 weeks of double-blind treatment, followed by a 2-week double-blind down-taper. The primary efficacy parameter was change from baseline on the clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) total score. The prespecified secondary efficacy parameter was change from baseline in Sheehan Disability Scale (SDS) total score. Additional efficacy measures included the 17-item Hamilton Depression Rating Scale (HDRS(17)) and Clinical Global Impressions-Severity of Illness (CGI-S) and -Improvement (CGI-I). Safety and tolerability were also evaluated. RESULTS: The least squares mean difference (LSMD) for change from baseline in MADRS total score was significantly superior to placebo for all dose groups: -3.23 (P = .0186), -3.99 (P = .0038), and -4.86 (P = .0005) for levomilnacipran SR 40, 80, and 120 mg, respectively. The LSMD was significantly different for levomilnacipran SR 80 mg and 120 mg versus placebo on the SDS (-2.51 and -2.57, respectively, P < .05 for both doses), HDRS(17) (-2.09 and -2.34, respectively, P < .05 for both doses), CGI-S (-0.43 [P < .01] and -0.35 [P < .05], respectively), and CGI-I (-0.34 and -0.32, respectively, P < .05 for both doses) assessments. The most common treatment-emergent adverse events (≥ 10% of any treatment group) were headache, nausea, constipation, dry mouth, increased heart rate, and hyperhidrosis. CONCLUSIONS: Levomilnacipran SR demonstrated significant improvement in depressive symptoms and functioning relative to placebo. In this study, levomilnacipran SR was generally well tolerated. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00969709. SN - 1555-2101 UR - https://www.unboundmedicine.com/medline/citation/23561229/Efficacy_and_safety_of_levomilnacipran_sustained_release_40_mg_80_mg_or_120_mg_in_major_depressive_disorder:_a_phase_3_randomized_double_blind_placebo_controlled_study_ L2 - http://www.psychiatrist.com/jcp/article/pages/2013/v74n03/v74n0310.aspx DB - PRIME DP - Unbound Medicine ER -