Duloxetine versus escitalopram and placebo in the treatment of patients with major depressive disorder: Onset of antidepressant action, a non-inferiority study

Current Medical Research and Opinion

Volumn 23, Issue 2, 2007, Pages 401-416

  Nierenberg, Andrew A ^a   Greist, John H ^b   Mallinckrodt, Craig H ^c   Prakash, Apurva ^c   Sambunaris, Angelo ^d   Tollefson, Gary D ^e   Wohlreich, Madelaine M ^c  

^a MASSACHUSETTS GENERAL HOSPITAL   (United States)

^b Healthcare Technology Systems Inc   (United States)

^c ELI LILLY AND COMPANY   (United States)

^d Behavioral Medicine Institute of Atlanta   (United States)

^e Lilly Corporate Center DC 4103 ^*

Author keywords

Antidepressants; Duloxetine; Escitalopram; Major depressive disorder; Onset of antidepressant action

Indexed keywords

ALPHA ADRENERGIC RECEPTOR BLOCKING AGENT; BENZODIAZEPINE DERIVATIVE; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; CALCIUM CHANNEL BLOCKING AGENT; CHLORAL HYDRATE; CITALOPRAM; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; DULOXETINE; ESCITALOPRAM; NARCOTIC AGENT; PLACEBO; ZOLPIDEM;

ADULT; AGED; ANXIETY; CLINICAL TRIAL; COMPARATIVE STUDY; CONFERENCE PAPER; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DECREASED APPETITE; DIARRHEA; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG WITHDRAWAL; ERECTILE DYSFUNCTION; FATIGUE; FEMALE; HAMILTON SCALE; HEADACHE; HUMAN; HYPERHIDROSIS; INSOMNIA; IRRITABILITY; LIBIDO DISORDER; MAJOR CLINICAL STUDY; MAJOR DEPRESSION; MALE; NAUSEA; OUTPATIENT CARE; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SIDE EFFECT; SINGLE DRUG DOSE; SOMNOLENCE; TREATMENT OUTCOME; VOMITING; XEROSTOMIA; YAWNING;

ADULT; ANTIDEPRESSIVE AGENTS; ARRHYTHMIA; CITALOPRAM; DEPRESSIVE DISORDER; DOUBLE-BLIND METHOD; FEMALE; GASTROINTESTINAL DISEASES; HUMANS; IMPOTENCE; IRRITABLE MOOD; MALE; MIDDLE AGED; PATIENT DROPOUTS; SEROTONIN UPTAKE INHIBITORS; SEVERITY OF ILLNESS INDEX; THIOPHENES; TREATMENT OUTCOME; XEROSTOMIA;

EID: 33847413286     PISSN: 03007995     EISSN: None     Source Type: Journal    
DOI: 10.1185/030079906X167453     Document Type: Conference Paper

References (60)

1. Piaggio G, Elbourne DR, Altman DG, et al. Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement. J Am Med Assoc 2006;295:1152-60
2. Nierenberg AA, Farabaugh AH, Alpert JE, et al. Timing of onset of antidepressant response with fluoxetine treatment. Am J Psychiatry 2000;157:1423-8
3. Blier P. Pharmacology of rapid-onset antidepressant treatment strategies. J Clin Psychiatry 2001;62(Suppl 15):12-7
4. Stahl SM, Nierenberg AA, Gorman JM. Evidence of early onset of antidepressant effect in randomized controlled trials. J Clin Psychiatry 2001;62(Suppl 4):17-23
5. Culpepper L. Early onset of antidepressant action: impact on primary care. J Clin Psychiatry 2001;62(Suppl 4):4-6
6. Lin EH, Von Korff M, Katon W, et al. The role of the primary care physician in patients' adherence to antidepressant therapy. Med Care 1995;33:67-74
7. Linden M, Gothe H, Dittmann RW, Schaaf B. Early termination of antidepressant drug treatment. J Clin Psychopharmacol 2000;20:523-30
8. Montgomery SA, Bech P, Blier P, et al. Selecting methodologies for the evaluation of differences in time to response between antidepressants. J Clin Psychiatry 2002;63:694-9
9. Artigas F, Romero L, de Montigny C, Blier P. Acceleration of the effect of selected antidepressant drugs in major depression by 5-HT1A antagonists. Trends Neurosci 1996;19:378-83
10. Blier P. Possible neurobiological mechanisms underlying faster onset of antidepressant action. J Clin Psychiatry 2001;62(Suppl 4):7-11
11. Briner K, Dodel RC. New approaches to rapid onset antidepressants. Curr Pharm Des 1998;4:291-302
12. Montgomery SA. Fast-onset antidepressants. Int Clin Psychopharmacol 1997;12(Suppl 3):S1-S5
13. Scorza C, Silveira R, Nichols DE, Reyes-Parada M. Effects of 5-HT-releasing agents on the extracellular hippocampal 5-HT of rats. Implications for the development of novel antidepressants with a short onset of action. Neuropharmacology 1999;38:1055-61
14. Dremencov E, Gispan-Herman I, Rosenstein M, et al. The serotonin-dopamine interaction is critical for fast-onset action of antidepressant treatment: in vivo studies in an animal model of depression. Prog Neuropsychopharmacol Biol Psychiatry 2004;28:141-7
15. Adell A, Castro E, Celada P, et al. Strategies for producing faster acting antidepressants. Drug Discov Today 2005;10:578-85
16. Miller FE. Strategies for the rapid treatment of depression. Hum Psychopharmacol 2001;16:125-32
17. Gorman JM, Korotzer A, Su G. Efficacy comparison of escitalopram and citalopram in the treatment of major depressive disorder: pooled analysis of placebo-controlled trials. CNS Spectr 2002;7:40-4
18. Entsuah R, Derivan A, Kikta D. Early onset of antidepressant action of venlafaxine: pattern analysis in intent-to-treat patients. Clin Ther 1998;20:517-26
19. Quitkin FM, Taylor BP, Kremer C. Does mirtazapine have a more rapid onset than SSRIs? J Clin Psychiatry 2001;62:358-61
20. Leon AC, Blier P, Culpepper L, et al. An ideal trial to test differential onset of antidepressant effect. J Clin Psychiatry 2001;62(Suppl 4):34-6
21. Behnke K, Sogaard J, Martin S, et al. Mirtazapine orally disintegrating tablet versus sertraline: a prospective onset of action study. J Clin Psychopharmacol 2003;23:358-64
22. Jouvent R, Le Houezec J, Payan C, et al. Dimensional assessment of onset of action of antidepressants: a comparative study of moclobemide vs. clomipramine in depressed patients with blunted affect and psychomotor retardation. Psychiatry Res 1998;79:267-75
23. Fabre LF. Treatment of depression in outpatients: a controlled comparison of the onset of action of amoxapine and maprotiline. J Clin Psychiatry 1985;46:521-4
24. Sir A, D'Souza RF, Uguz S, et al. Randomized trial of sertraline versus venlafaxine XR in major depression: efficacy and discontinuation symptoms. J Clin Psychiatry 2005;66:1312-20
25. Leon AC. Measuring onset of antidepressant action in clinical trials: an overview of definitions and methodology. J Clin Psychiatry 2001;62(Suppl 4):12-6
26. Burke WJ, Gergel I, Bose A. Fixed-dose trial of the single isomer SSRI escitalopram in depressed outpatients. J Clin Psychiatry 2002;63:331-6
27. Montgomery SA, Loft H, Sanchez C, et al. Escitalopram (S-enantiomer of citalopram): clinical efficacy and onset of action predicted from a rat model. Pharmacol Toxicol 2001;88:282-6
28. Wade A, Michael Lemming O, Bang Hedegaard K. Escitalopram 10 mg/day is effective and well tolerated in a placebo-controlled study in depression in primary care. Int Clin Psychopharmacol 2002;17:95-102
29. Detke MJ, Lu Y, Goldstein DJ, et al. Duloxetine, 60 mg once daily, for major depressive disorder: a randomized double-blind placebo-controlled trial. J Clin Psychiatry 2002;63:308-15
30. Detke MJ, Lu Y, Goldstein DJ, et al. Duloxetine 60 mg once daily dosing versus placebo in the acute treatment of major depression. J Psychiatr Res 2002;36:383-90
31. Leon AC. Measuring onset of antidepressant action in clinical trials: an overview of definitions and methodology. J Clin Psychiatry 2001;62(Suppl 4):12-6
32. Mallinckrodt CH, Detke MJ, Kaiser CJ, et al. Comparing onset of antidepressant action using a repeated measures approach and a traditional assessment schedule. Stat Med 2006;25:2384-97
33. American Psychiatric Association. Diagnostic and statistical manual of mental disorders, 4th ed. Washington: APA; 1994
34. Sheehan DV, Lecrubier Y, Sheehan KH, et al. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry 1998;59(Suppl 20):22-33
35. Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry 1979;134:382-9
36. Guy W. ECDEU assessment manual for psychopharmacology [revised]. Rockville: National Institutes of Mental Health; 1976
37. Maier W, Philipp M. Improving the assessment of severity of depressive states: a reduction of the Hamilton Depression Scale. Pharmacopsychiatry 1985;18:114-5
38. Stassen HH, Delini-Stula A, Angst J. Time course of improvement under antidepressant treatment: a survival-analytical approach. Eur Neuropsychopharmacol 1993;3:127-35
39. Faries D, Herrera J, Rayamajhi J, et al. The responsiveness of the Hamilton Depression Rating Scale. J Psychiatr Res 2000;34:3-10
40. Quitkin FM, Rabkin JD, Markowitz JM, et al. Use of pattern analysis to identify true drug response. A replication. Arch Gen Psychiatry 1987;44:259-64
41. Quitkin FM, Rabkin JG, Ross D, Stewart JW. Identification of true drug response to antidepressants. Use of pattern analysis. Arch Gen Psychiatry 1984;41:782-6
42. Hamilton M. A rating scale for depression. J Neurol Neurosurg Psychiatry 1960;23:56-62
43. Hamilton M. Development of a rating scale for primary depressive illness. Br J Soc Clin Psychol 1967;6:278-96
44. Keller MB. Past, present, and future directions for defining optimal treatment outcome in depression: remission and beyond. J Am Med Assoc 2003;289:3152-60
45. Hamilton M. The assessment of anxiety states by rating. Br J Med Psychol 1959;32:50-5
46. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand 1983;67:361-70
47. Clayton AH, McGarvey EL, Clavet GJ. The Changes in Sexual Functioning Questionnaire (CSFQ): development, reliability, and validity. Psychopharmacol Bull 1997;33:731-45
48. Lieberman JA, Greenhouse J, Hamer RM, et al. Comparing the effects of antidepressants: consensus guidelines for evaluating quantitative reviews of antidepressant efficacy. Neuropsychopharmacology 2005;30:445-60
49. Kasper S, Spadone C, Verpillat P, Angst J. Onset of action of escitalopram compared with other antidepressants: results of a pooled analysis. Int Clin Psychopharmacol 2006;21:105-10
50. Thase ME, Entsuah AR, Rudolph RL. Remission rates during treatment with venlafaxine or selective serotonin reuptake inhibitors. Br J Psychiatry 2001;178:234-41
51. Shelton C, Entsuah R, Padmanabhan SK, Vinall PE. Venlafaxine XR demonstrates higher rates of sustained remission compared to fluoxetine, paroxetine or placebo. Int Clin Psychopharmacol 2005;20:233-8
52. Dunner DL, Wohlreich MM, Mallinckrodt CH, et al. Clinical consequences of initial duloxetine dosing strategies: comparison of 30 and 60 mg QD starting doses. Curr Ther Res Clin Exp 2005;66:522-40
53. Dunner D, Kornstein S, Whitmeyer V, et al. Effects of initial dosing strategies of duloxetine on tolerability and efficacy in patients with major depressive disorder. Presented at the 45th annual meeting of the American College of Neuropsychopharmacology December 4, 2006, Hollywood (FL)
54. Mallinckrodt CH, Prakash A, Andorn AC, et al. Duloxetine for the treatment of major depressive disorder: a closer look at efficacy and safety data across the approved dose range. J Psychiatr Res 2006;40:337-48
55. Rush AJ, Bose A. Escitalopram in clinical practice: results of an open-label trial in a naturalistic setting. Depress Anxiety 2005;21:26-32
56. Khan A, Khan SR, Walens G, et al. Frequency of positive studies among fixed and flexible dose antidepressant clinical trials: an analysis of the food and drug administration summary basis of approval reports. Neuropsychopharmacology 2003;28:552-7
57. Brown WA, Harrison W. Are patients who are intolerant to one serotonin selective reuptake inhibitor intolerant to another? J Clin Psychiatry. 1995;56:30-4
58. Thase ME, Blomgren SL, Birkett MA, et al. Fluoxetine treatment of patients with major depressive disorder who failed initial treatment with sertraline. J Clin Psychiatry 1997;58:16-21
59. Quitkin FM, McGrath PJ, Stewart JW, et al. Remission rates with 3 consecutive antidepressant trials: effectiveness for depressed outpatients. J Clin Psychiatry 2005;66:670-6
60. Rush AJ, Trivedi MH, Wisniewski SR, et al. Bupropion-SR, sertraline, or venlafaxine-XR after failure of SSRIs for depression. New Engl J Med. 2006;354:1231-42