The efficacy of extended-Release levomilnacipran in moderate to severe major depressive disorder: secondary and post-hoc analyses from a randomized, double-blind, placebo-controlled study

International Clinical Psychopharmacology

Volumn 29, Issue 1, 2014, Pages 26-35

  Montgomery, Stuart A ^a   Mansuy, Lucilla ^b   Ruth, Adam C ^c   Li, Dayong ^d   Gommoll, Carl ^d  

^a IMPERIAL COLLEGE SCHOOL OF MEDICINE   (United Kingdom)

^b INSTITUT DE RECHERCHE PIERRE FABRE   (France)

^c Prescott Medical Communications Group   (United States)

^d FOREST RESEARCH INSTITUTE   (United States)

Author keywords

depression remission; Hamilton Depression Rating Scale; levomilnacipran extended release; major depressive disorder; Montgomery Asberg Depression Rating Scale; post hoc analyses; serotonin and norepinephrine reuptake inhibitor; severe depression; Sheehan Disability Scale

Indexed keywords

MILNACIPRAN; PLACEBO;

ADULT; AGED; AGITATION; ANXIETY; ARTICLE; CONTROLLED STUDY; DRUG DOSE INCREASE; DRUG DOSE TITRATION; DRUG EFFECT; DRUG EFFICACY; DRUG RELEASE; DRUG RESPONSE; DRUG SAFETY; DRUG WITHDRAWAL; FAMILY LIFE; FUNCTIONAL DISEASE; GENERAL CONDITION DETERIORATION; GUILT; HAMILTON SCALE; HUMAN; HYPOCHONDRIASIS; INSOMNIA; INTROSPECTION; MAJOR CLINICAL STUDY; MAJOR DEPRESSION; MONTGOMERY ASBERG DEPRESSION RATING SCALE; PRIORITY JOURNAL; PSYCHOMOTOR RETARDATION; REMISSION; SECONDARY ANALYSIS; SHEEHAN DISABILITY SCALE; SOCIAL LIFE; SUICIDE; UNSPECIFIED SIDE EFFECT; WEIGHT REDUCTION;

ADOLESCENT; ADULT; AGED; ANTIDEPRESSIVE AGENTS, SECOND-GENERATION; CYCLOPROPANES; DELAYED-ACTION PREPARATIONS; DEPRESSIVE DISORDER, MAJOR; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; PSYCHIATRIC STATUS RATING SCALES; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84890439582     PISSN: 02681315     EISSN: 14735857     Source Type: Journal    
DOI: 10.1097/YIC.0000000000000009     Document Type: Article

References (33)

1. Altman DG (1998). Confidence intervals for the number needed to treat. BMJ 317:1309-1312
2. American Psychiatric Association (2000). Diagnostic and Statistical Manual of Mental Disorders. Fourth edition, text revision Washington, DC: American Psychiatric Association
3. Asnis G, Bose A, Gommoll C, Chen C, Greenberg WM (2013). The efficacy and safety of levomilnacipran SR 40 mg, 80 mg, or 120 mg in major depressive disorder: A phase III, randomized, double-blind, placebo-controlled study. J Clin Psychiatry 74:242-248
4. Auclair AL, Martel JC, Assié MB, Bardin L, Heusler P, Marien M, et al. (2013). Levomilnacipran (F2695), a norepinephrine-preferring SNRI: Profile in vitro and in models of depression and anxiety. Neuropharmacology 70:338-347
5. Bakish D, Bose A, Gommoll C, Chen C, Greenberg WM, Nunez R, et al. (2013). Levomilnacipran ER 40mg and 80mg in major depressive disorder: A phase III, randomized, double-blind, fixed-dose, placebo-controlled study. J Psychiatry Neurosci [in press
6. Charney DS (1998). Monoamine dysfunction and the pathophysiology and treatment of depression. J Clin Psychiatry 59 (Suppl 14):11-14
7. Cipriani A, Barbui C, Brambilla P, Furukawa TA, Hotopf M, Geddes JR (2006). Are all antidepressants really the same? The case of fluoxetine: A systematic review. J Clin Psychiatry 67:850-864
8. Deecher DC, Beyer CE, Johnston G, Bray J, Shah S, Abou-Gharbia M, Andree TH (2006). Desvenlafaxine succinate: A new serotonin and norepinephrine reuptake inhibitor. J Pharmacol Exp Ther 318:657-665
9. Favre P (2012). Clinical efficacy and achievement of a complete remission in depression: Increasing interest in treatment with escitalopram. Encephale 38:86-96
10. Gommoll C, Bose A, Li H, Edwards J (2011). A randomized double-blind, placebo-controlled, flexible-dose study of levomilnacipran in patients with major depressive disorder. Poster presented at the 24th Annual US Psychiatric and Mental Health Congress; Las Vegas, NV, November 7-10
11. Hamilton M (1960). A rating scale for depression. J Neurol Neurosurg Psychiatry 23:56-62
12. Israel JA (2006). Remission in depression: Definition and initial treatment approaches. J Psychopharmacol 20:5-10
13. Judd LL, Akiskal HS, Paulus MP (1997). The role and clinical significance of subsyndromal depressive symptoms (SSD) in unipolar major depressive disorder. J Affect Disord 45:5-17
14. Kraemer HC, Kupfer DJ (2006). Size of treatment effects and their importance to clinical research and practice. Biol Psychiatry 59:990-996
15. Leonard BE (1997). Noradrenaline in basic models of depression. Eur Neuropsychopharmacol 7 (Suppl 1):S11-S16
16. Montgomery SA, Asberg M (1979). A new depression scale designed to be sensitive to change. Br J Psychiatry 134:382-389
17. Montgomery SA, Moller HJ (2009). Is the significant superiority of escitalopram compared with other antidepressants clinically relevant? Int Clin Psychopharmacol 24:111-118
18. Montgomery SA, Doogan DP, Burnside R (1991). The influence of different relapse criteria on the assessment of long-term efficacy of sertraline. Int Clin Psychopharmacol 6 (Suppl 2):37-46
19. Montgomery SA, Mansuy L, Ruth A, Bose A, Li H, Li D (2013). Efficacy and safety of levomilnacipran sustained release in moderate to severe major depressive disorder: A randomized, double-blind, placebo-controlled, proof-ofconcept study. J Clin Psychiatry 74:363-369
20. Nutt DJ (2008). Relationship of neurotransmitters to the symptoms of major depressive disorder. J Clin Psychiatry 69 (Suppl E1):4-7
21. Pintor L, Torres X, Navarro V, Matrai S, Gasto C (2004). Is the type of remission after a major depressive episode an important risk factor to relapses in a 4-year follow up? J Affect Disord 82:291-296
22. Rush AJ, Trivedi MH, Wisniewski SR, Nierenberg AA, Stewart JW, Warden D, et al. (2006). Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: A STAR*D report. Am J Psychiatry 163:1905-1917
23. Rutherford BR, Roose SP (2013). A model of placebo response in antidepressant clinical trials. Am J Psychiatry 170:723-733
24. Sambunaris A, Bose A, Gommoll C, Chen C, Greenberg WM, Zukin SR, Sheehan DV (2012). W14. A phase III, double-blind, placebo-controlled, flexible-dose study of levomilnacipran SR in patients with major depressive disorder. Neuropsychopharmacology 38 (Suppl 1):S322-S323, Abstract
25. Sheehan DV, Harnett-Sheehan K, Raj BA (1996). The measurement of disability. Int Clin Psychopharmacol 11 (Suppl 3):89-95
26. Sheehan DV, Harnett-Sheehan K, Spann ME, Thompson HF, Prakash A (2011). Assessing remission in major depressive disorder and generalized anxiety disorder clinical trials with the discan metric of the Sheehan disability scale. Int Clin Psychopharmacol 26:75-83
27. Sheehan KH, Sheehan DV (2008). Assessing treatment effects in clinical trials with the discan metric of the Sheehan Disability Scale. Int Clin Psychopharmacol 23:70-83
28. Shiovitz T, Bose A, Greenberg WM, Chen C, Forero G, Gommoll C, Malberg J (2012). The efficacy and safety of levomilnacipran SR in the prevention of relapse in major depressive disorder: Results from a phase III clinical trial. Presented at the 25th Annual U.S. Psychiatric and Mental Health Congress; San Diego, CA, November 8-11
29. Thase ME (2008). Do antidepressants really work? A clinicians' guide to evaluating the evidence. Curr Psychiatry Rep 10:487-494
30. Thase ME (2009). Update on partial response in depression. J Clin Psychiatry 70 (Suppl 6):4-9
31. Thase ME (2011). The small specific effects of antidepressants in clinical trials: What do they mean to psychiatrists? Curr Psychiatry Rep 13:476-482
32. Wade AG, Schlaepfer TE, Andersen HF, Kilts CD (2009). Clinical milestones predict symptom remission over 6-month and choice of treatment of patients with major depressive disorder (MDD). J Psychiatr Res 43:568-575
33. Zimmerman M, Chelminski I, Posternak M (2004). A review of studies of the Montgomery-Asberg Depression Rating Scale in controls: Implications for the definition of remission in treatment studies of depression. Int Clin Psychopharmacol 19:1-7