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Meta-Analysis
. 2012 Oct 17;10(10):CD006533.
doi: 10.1002/14651858.CD006533.pub2.

Duloxetine versus other anti-depressive agents for depression

Andrea Cipriani  1 , Markus Koesters, Toshi A Furukawa, Michela Nosè, Marianna Purgato, Ichiro M Omori, Carlotta Trespidi, Corrado Barbui
Affiliations
Meta-Analysis

Duloxetine versus other anti-depressive agents for depression

Andrea Cipriani et al. Cochrane Database Syst Rev. .

Abstract

Background: Although pharmacological and psychological interventions are both effective for major depression, in primary and secondary care settings antidepressant drugs remain the mainstay of treatment. Amongst antidepressants many different agents are available. Duloxetine hydrochloride is a dual reuptake inhibitor of serotonin and norepinephrine and has been licensed by the Food and Drug Administration in the US for major depressive disorder (MDD), generalised anxiety disorder, diabetic peripheral neuropathic pain, fibromyalgia and chronic musculoskeletal pain.

Objectives: To assess the evidence for the efficacy, acceptability and tolerability of duloxetine in comparison with all other antidepressant agents in the acute-phase treatment of major depression.

Search methods: MEDLINE (1966 to 2012), EMBASE (1974 to 2012), the Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Register and the Cochrane Central Register of Controlled Trials up to March 2012. No language restriction was applied. Reference lists of relevant papers and previous systematic reviews were hand-searched. Pharmaceutical company marketing duloxetine and experts in this field were contacted for supplemental data.

Selection criteria: Randomised controlled trials allocating patients with major depression to duloxetine versus any other antidepressive agent.

Data collection and analysis: Two review authors independently extracted data and a double-entry procedure was employed. Information extracted included study characteristics, participant characteristics, intervention details and outcome measures in terms of efficacy, acceptability and tolerability.

Main results: A total of 16 randomised controlled trials (overall 5735 participants) were included in this systematic review. Of these, three trials were unpublished. We found 11 studies (overall 3304 participants) comparing duloxetine with one selective serotonin reuptake inhibitor (SSRI) (six studies versus paroxetine, three studies versus escitalopram and two versus fluoxetine), four studies (overall 1978 participants) comparing duloxetine with a newer antidepressants (three with venlafaxine and one with desvenlafaxine, respectively) and one study (overall 453 participants) comparing duloxetine with an antipsychotic drug which is also used as an antidepressive agent, quetiapine. No studies were found comparing duloxetine with tricyclic antidepressants. The pooled confidence intervals were rather wide and there were no statistically significant differences in efficacy when comparing duloxetine with other antidepressants. However, when compared with escitalopram or venlafaxine, there was a higher rate of drop out due to any cause in the patients randomised to duloxetine (odds ratio (OR) 1.62; 95% confidence interval (CI) 1.01 to 2.62 and OR 1.56; 95% CI 1.14 to 2.15, respectively). There was also some weak evidence suggesting that patients taking duloxetine experienced more adverse events than paroxetine (OR 1.24; 95% CI 0.99 to 1.55).

Authors' conclusions: Duloxetine did not seem to provide a significant advantage in efficacy over other antidepressive agents for the acute-phase treatment of major depression. No differences in terms of efficacy were found, even though duloxetine was worse than some SSRIs (most of all, escitalopram) and newer antidepressants (like venlafaxine) in terms of acceptability and tolerability. Unfortunately, we only found evidence comparing duloxetine with a handful of other active antidepressive agents and only a few trials per comparison were found (in some cases we retrieved just one trial). This limited the power of the review to detect moderate, but clinically meaningful differences between the drugs. As many statistical tests have been used in the review, the findings from this review are better thought of as hypothesis forming rather than hypothesis testing and it would be very comforting to see the conclusions replicated in future trials. Most of included studies were sponsored by the drug industry manufacturing duloxetine. As for all other new investigational compounds, the potential for overestimation of treatment effect due to sponsorship bias should be borne in mind. In the present review no trials reported economic outcomes. Given that several SSRIs and the great majority of antidepressants are now available as generic formulation (only escitalopram, desvenlafaxine and duloxetine are still on patent), more comprehensive economic estimates of antidepressant treatment effect should be considered to better inform healthcare policy.

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Conflict of interest statement

AC, CB, MN, IMO, CT, MP, SD, MK: none declared.

TAF has received honoraria for speaking at CME meetings sponsored by Asahi Kasei, Eli Lilly, GlaxoSmithKline, Mochida, MSD, Otsuka, Pfizer, Shionogi and Tanabe‐Mitsubishi. He is diplomate of the Academy of Cognitive Therapy. He has received royalties from Igaku‐Shoin, Seiwa‐Shoten and Nihon Bunka Kagaku‐sha. He is on advisory board for Sekisui Chemicals and Takeda Science Foundation. The Japanese Ministry of Education, Science, and Technology, the Japanese Ministry of Health, Labor and Welfare, and the Japan Foundation for Neuroscience and Mental Health have funded his research projects.

Figures

1
1
'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
2
2
'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
3
3
Forest plot of comparison: 1 Failure to respond at endpoint (6‐12 weeks), outcome: 1.2 Duloxetine versus other SSRIs.
4
4
Forest plot of comparison: 8 Failure to complete (any cause), outcome: 8.2 Duloxetine versus other SSRIs.
5
5
Forest plot of comparison: 8 Failure to complete (any cause), outcome: 8.2 Duloxetine versus newer ADs.
1.1
1.1. Analysis
Comparison 1 Failure to respond at endpoint (6‐12 weeks), Outcome 1 Duloxetine versus SSRIs.
1.2
1.2. Analysis
Comparison 1 Failure to respond at endpoint (6‐12 weeks), Outcome 2 Duloxetine versus newer ADs.
2.1
2.1. Analysis
Comparison 2 Failure to respond (16‐24 weeks), Outcome 1 Duloxetine versus SSRIs.
2.2
2.2. Analysis
Comparison 2 Failure to respond (16‐24 weeks), Outcome 2 Duloxetine versus newer ADs.
3.1
3.1. Analysis
Comparison 3 Failure to remit (6‐12 weeks), Outcome 1 Duloxetine versus SSRIs.
3.2
3.2. Analysis
Comparison 3 Failure to remit (6‐12 weeks), Outcome 2 Duloxetine versus newer ADs.
4.1
4.1. Analysis
Comparison 4 Failure to remit (16‐24 weeks), Outcome 1 Duloxetine versus SSRIs.
5.1
5.1. Analysis
Comparison 5 Mean difference at endpoint (6‐12 weeks), Outcome 1 Duloxetine versus SSRIs.
5.2
5.2. Analysis
Comparison 5 Mean difference at endpoint (6‐12 weeks), Outcome 2 Duloxetine versus newer ADs.
6.1
6.1. Analysis
Comparison 6 Mean difference (1‐4 weeks), Outcome 1 Duloxetine versus SSRIs.
6.2
6.2. Analysis
Comparison 6 Mean difference (1‐4 weeks), Outcome 2 Duloxetine versus newer ADs.
7.1
7.1. Analysis
Comparison 7 Standardised mean difference (16‐24 weeks), Outcome 1 Duloxetine versus SSRIs.
8.1
8.1. Analysis
Comparison 8 Failure to complete (any cause), Outcome 1 Duloxetine versus SSRIs.
8.2
8.2. Analysis
Comparison 8 Failure to complete (any cause), Outcome 2 Duloxetine versus newer ADs.
9.1
9.1. Analysis
Comparison 9 Failure to complete (inefficacy), Outcome 1 Duloxetine versus SSRIs.
9.2
9.2. Analysis
Comparison 9 Failure to complete (inefficacy), Outcome 2 Duloxetine versus newer ADs.
10.1
10.1. Analysis
Comparison 10 Failure to complete (side effects), Outcome 1 Duloxetine versus SSRIs.
10.2
10.2. Analysis
Comparison 10 Failure to complete (side effects), Outcome 2 Duloxetine versus newer ADs.
11.1
11.1. Analysis
Comparison 11 SE ‐ Participants with at least one TEAE, Outcome 1 Duloxetine versus SSRIs.
11.2
11.2. Analysis
Comparison 11 SE ‐ Participants with at least one TEAE, Outcome 2 Duloxetine versus newer ADs.
12.1
12.1. Analysis
Comparison 12 SE ‐ Abnormal thinking, Outcome 1 Duloxetine versus SSRIs.
13.1
13.1. Analysis
Comparison 13 SE ‐ Accidental injury, Outcome 1 Duloxetine versus SSRIs.
14.1
14.1. Analysis
Comparison 14 SE ‐ Alanine aminotransferase increase, Outcome 1 Duloxetine versus SSRIs.
15.1
15.1. Analysis
Comparison 15 SE ‐ Anorexia, Outcome 1 Duloxetine versus SSRIs.
15.2
15.2. Analysis
Comparison 15 SE ‐ Anorexia, Outcome 2 Duloxetine versus newer ADs.
16.1
16.1. Analysis
Comparison 16 SE ‐ Anxiety/agitation, Outcome 1 Duloxetine versus SSRIs.
16.2
16.2. Analysis
Comparison 16 SE ‐ Anxiety/agitation, Outcome 2 Duloxetine versus newer ADs.
17.1
17.1. Analysis
Comparison 17 SE ‐ Appetite decreased, Outcome 1 Duloxetine versus SSRIs.
17.2
17.2. Analysis
Comparison 17 SE ‐ Appetite decreased, Outcome 2 Duloxetine versus newer ADs.
18.1
18.1. Analysis
Comparison 18 SE ‐ Appetite increased, Outcome 1 Duloxetine versus SSRIs.
19.1
19.1. Analysis
Comparison 19 SE ‐ Asthenia, Outcome 1 Duloxetine versus SSRIs.
20.1
20.1. Analysis
Comparison 20 SE ‐ Chills, Outcome 1 Duloxetine versus SSRIs.
21.1
21.1. Analysis
Comparison 21 SE ‐ Constipation, Outcome 1 Duloxetine versus SSRIs.
21.2
21.2. Analysis
Comparison 21 SE ‐ Constipation, Outcome 2 Duloxetine versus newer ADs.
22.1
22.1. Analysis
Comparison 22 SE ‐ Cough, Outcome 1 Duloxetine versus SSRIs.
23.1
23.1. Analysis
Comparison 23 SE ‐ Diarrhoea, Outcome 1 Duloxetine versus SSRIs.
23.2
23.2. Analysis
Comparison 23 SE ‐ Diarrhoea, Outcome 2 Duloxetine versus newer ADs.
24.1
24.1. Analysis
Comparison 24 SE ‐ Dizziness, Outcome 1 Duloxetine versus SSRIs.
24.2
24.2. Analysis
Comparison 24 SE ‐ Dizziness, Outcome 2 Duloxetine versus newer ADs.
25.1
25.1. Analysis
Comparison 25 SE ‐ Dream activity increased, Outcome 1 Duloxetine versus SSRIs.
25.2
25.2. Analysis
Comparison 25 SE ‐ Dream activity increased, Outcome 2 Duloxetine versus newer ADs.
26.1
26.1. Analysis
Comparison 26 SE ‐ Dry mouth, Outcome 1 Duloxetine versus SSRIs.
26.2
26.2. Analysis
Comparison 26 SE ‐ Dry mouth, Outcome 2 Duloxetine versus newer ADs.
27.1
27.1. Analysis
Comparison 27 SE ‐ Dyspepsia, Outcome 1 Duloxetine versus SSRIs.
27.2
27.2. Analysis
Comparison 27 SE ‐ Dyspepsia, Outcome 2 Duloxetine versus newer ADs.
28.1
28.1. Analysis
Comparison 28 SE ‐ Dyspnea, Outcome 1 Duloxetine versus SSRIs.
29.1
29.1. Analysis
Comparison 29 SE ‐ Fatigue, Outcome 1 Duloxetine versus SSRIs.
29.2
29.2. Analysis
Comparison 29 SE ‐ Fatigue, Outcome 2 Duloxetine versus newer ADs.
30.1
30.1. Analysis
Comparison 30 SE ‐ Fever, Outcome 1 Duloxetine versus SSRIs.
31.1
31.1. Analysis
Comparison 31 SE ‐ Flatulence, Outcome 1 Duloxetine versus SSRIs.
32.1
32.1. Analysis
Comparison 32 SE ‐ Headache, Outcome 1 Duloxetine versus SSRIs.
32.2
32.2. Analysis
Comparison 32 SE ‐ Headache, Outcome 2 Duloxetine versus newer ADs.
33.1
33.1. Analysis
Comparison 33 SE ‐ Hypersomnia, Outcome 1 Duloxetine versus SSRIs.
34.1
34.1. Analysis
Comparison 34 SE ‐ Hypertonia, Outcome 1 Duloxetine versus SSRIs.
35.1
35.1. Analysis
Comparison 35 SE ‐ Hypertension, Outcome 1 Duloxetine versus SSRIs.
36.1
36.1. Analysis
Comparison 36 SE ‐ Hypotonia, Outcome 1 Duloxetine versus SSRIs.
37.1
37.1. Analysis
Comparison 37 SE ‐ Infection, Outcome 1 Duloxetine versus SSRIs.
38.1
38.1. Analysis
Comparison 38 SE ‐ Influenza‐like symptoms, Outcome 1 Duloxetine versus SSRIs.
39.1
39.1. Analysis
Comparison 39 SE ‐ Insomnia, Outcome 1 Duloxetine versus SSRIs.
39.2
39.2. Analysis
Comparison 39 SE ‐ Insomnia, Outcome 2 Duloxetine versus newer ADs.
40.1
40.1. Analysis
Comparison 40 SE ‐ Musculoskeletal and connective tissue disorders, Outcome 1 Duloxetine versus SSRIs.
41.1
41.1. Analysis
Comparison 41 SE ‐ Nausea/vomiting, Outcome 1 Duloxetine versus SSRIs.
41.2
41.2. Analysis
Comparison 41 SE ‐ Nausea/vomiting, Outcome 2 Duloxetine versus newer ADs.
42.1
42.1. Analysis
Comparison 42 SE ‐ Nervousness, Outcome 1 Duloxetine versus SSRIs.
43.1
43.1. Analysis
Comparison 43 SE ‐ Pain (abdominal), Outcome 1 Duloxetine versus SSRIs.
44.1
44.1. Analysis
Comparison 44 SE ‐ Pain (back), Outcome 1 Duloxetine versus SSRIs.
45.1
45.1. Analysis
Comparison 45 SE ‐ Pain (chest), Outcome 1 Duloxetine versus SSRIs.
46.1
46.1. Analysis
Comparison 46 SE ‐ Pain (general), Outcome 1 Duloxetine versus SSRIs.
47.1
47.1. Analysis
Comparison 47 SE ‐ Pain (neck), Outcome 1 Duloxetine versus SSRIs.
48.1
48.1. Analysis
Comparison 48 SE ‐ Palpitations, Outcome 1 Duloxetine versus SSRIs.
48.2
48.2. Analysis
Comparison 48 SE ‐ Palpitations, Outcome 2 Duloxetine versus newer ADs.
49.1
49.1. Analysis
Comparison 49 SE ‐ Paraesthesia, Outcome 1 Duloxetine versus SSRIs.
49.2
49.2. Analysis
Comparison 49 SE ‐ Paraesthesia, Outcome 2 Duloxetine versus newer ADs.
50.1
50.1. Analysis
Comparison 50 SE ‐ Pharyngitis, Outcome 1 Duloxetine versus SSRIs.
51.1
51.1. Analysis
Comparison 51 SE ‐ Pruritus, Outcome 1 Duloxetine versus SSRIs.
52.1
52.1. Analysis
Comparison 52 SE ‐ Rash, Outcome 1 Duloxetine versus SSRIs.
53.1
53.1. Analysis
Comparison 53 SE ‐ Restlessness, Outcome 1 Duloxetine versus SSRIs.
54.1
54.1. Analysis
Comparison 54 SE ‐ Rhinitis, Outcome 1 Duloxetine versus SSRIs.
55.1
55.1. Analysis
Comparison 55 SE ‐ Sexual problems, Outcome 1 Anorgasmia.
55.2
55.2. Analysis
Comparison 55 SE ‐ Sexual problems, Outcome 2 Erectile dysfunction.
55.3
55.3. Analysis
Comparison 55 SE ‐ Sexual problems, Outcome 3 Loss of sexual interest.
55.4
55.4. Analysis
Comparison 55 SE ‐ Sexual problems, Outcome 4 Other sexual problems.
56.1
56.1. Analysis
Comparison 56 SE ‐ Sinusitis, Outcome 1 Duloxetine versus SSRIs.
57.1
57.1. Analysis
Comparison 57 SE ‐ Sleepiness/somnolence, Outcome 1 Duloxetine versus SSRIs.
57.2
57.2. Analysis
Comparison 57 SE ‐ Sleepiness/somnolence, Outcome 2 Duloxetine versus newer ADs.
58.1
58.1. Analysis
Comparison 58 SE ‐ Surgical procedure, Outcome 1 Duloxetine versus SSRIs.
59.1
59.1. Analysis
Comparison 59 SE ‐ Sweating, Outcome 1 Duloxetine versus SSRIs.
59.2
59.2. Analysis
Comparison 59 SE ‐ Sweating, Outcome 2 Duloxetine versus newer ADs.
60.1
60.1. Analysis
Comparison 60 SE ‐ Tachycardia, Outcome 1 Duloxetine versus SSRIs.
61.1
61.1. Analysis
Comparison 61 SE ‐ Tension, Outcome 1 Duloxetine versus SSRIs.
62.1
62.1. Analysis
Comparison 62 SE ‐ Tinnitus, Outcome 1 Duloxetine versus SSRIs.
63.1
63.1. Analysis
Comparison 63 SE ‐ Tremor, Outcome 1 Duloxetine versus SSRIs.
63.2
63.2. Analysis
Comparison 63 SE ‐ Tremor, Outcome 2 Duloxetine versus newer ADs.
64.1
64.1. Analysis
Comparison 64 SE ‐ Twitching, Outcome 1 Duloxetine versus SSRIs.
65.1
65.1. Analysis
Comparison 65 SE ‐ Unespected benefit, Outcome 1 Duloxetine versus SSRIs.
66.1
66.1. Analysis
Comparison 66 SE ‐ Upper respiratory tract infection, Outcome 1 Duloxetine versus SSRIs.
66.2
66.2. Analysis
Comparison 66 SE ‐ Upper respiratory tract infection, Outcome 2 Duloxetine versus newer ADs.
67.1
67.1. Analysis
Comparison 67 SE ‐ Urination problems, Outcome 1 Duloxetine versus SSRIs.
68.1
68.1. Analysis
Comparison 68 SE ‐ Vasodilatation, Outcome 1 Duloxetine versus SSRIs.
69.1
69.1. Analysis
Comparison 69 SE ‐ Vertigo, Outcome 1 Duloxetine versus SSRIs.
70.1
70.1. Analysis
Comparison 70 SE ‐ Visual problems (accommodation disorders, blurred vision, detached retina, mydriasis), Outcome 1 Duloxetine versus SSRIs.
70.2
70.2. Analysis
Comparison 70 SE ‐ Visual problems (accommodation disorders, blurred vision, detached retina, mydriasis), Outcome 2 Duloxetine versus newer ADs.
71.1
71.1. Analysis
Comparison 71 SE ‐ Weakness, Outcome 1 Duloxetine versus SSRIs.
72.1
72.1. Analysis
Comparison 72 SE ‐ Weight gain, Outcome 1 Duloxetine versus SSRIs.
73.1
73.1. Analysis
Comparison 73 SE ‐ Weight loss, Outcome 1 Duloxetine versus SSRIs.
74.1
74.1. Analysis
Comparison 74 SE ‐ Yawning, Outcome 1 Duloxetine versus SSRIs.
74.2
74.2. Analysis
Comparison 74 SE ‐ Yawning, Outcome 2 Duloxetine versus newer ADs.
75.1
75.1. Analysis
Comparison 75 Subgroup analysis ‐ Failure to respond at endpoint (6‐12 weeks), Outcome 1 Duloxetine versus paroxetine.
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Update of

References

References to studies included in this review

Cutler 2009 {published data only}
    1. Cutler AJ, Montgomery SA, Feifel D, Lazarus A, Astrom M, Brecher M. Extended release quetiapine fumarate monotherapy in major depressive disorder: a placebo‐ and duloxetine‐controlled study. Journal of Clinical Psychiatry 2009;70(4):526‐39. - PubMed
Detke 2004 (HMAY A) {published data only}
    1. Detke MJ, Wiltse CG, Mallinckrodt CH, McNamara RK, Demitrack MA, Bitter I. Duloxetine in the acute and long‐term treatment of major depressive disorder: a placebo‐ and paroxetine‐controlled trial. Europen Neuropsychopharmacology 2004;14(6):457‐70. - PubMed
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Goldstein 2002 (HMAQ A) {published and unpublished data}
    1. Demitrack MA, Goldstein DJ, Mallinckrodt C, Lu Y. Efficacy and safety of duloxetine treatment in major depression. 154th Annual Meeting of American Psychiatric Association. 2001 May 5‐10; New Orleans.
    1. Eli Lilly. Duloxetine versus placebo in the treatment of major depression [Trial 3327a, HAMAQ A]. http://www.clinicalstudyresults.org/documents/company‐study_137_0.pdf [accessed 5 October 2007, archived data on file].
    1. Goldstein DJ, Mallinckrodt C, Lu Y, Demitrack MA. Duloxetine in the treatment of major depressive disorder: a double‐blind clinical trial. Journal Clinical Psychiatry 2002;63(3):225‐31. - PubMed
Goldstein 2004 (HMAT B) {published and unpublished data}
    1. Eli Lilly. Duloxetine versus placebo and paroxetine in the acute treatment of major depression [Trial 4091b, HMAT B]. http://www.clinicalstudyresults.org/documents/company‐study_139_0.pdf [accessed 5 October 2007, archived data on file].
    1. Goldstein DJ, Lu Y, Dekte MJ, Wiltse CG, Mallinckrodt C, Demitrack MA. Duloxetine versus paroxetine in the treatment of depression. 155th Annual Meeting of American Psychiatric Association. 2002 May 18‐23; Philadelphia.
    1. Goldstein DJ, Lu Y, Detke M, Wiltse C, Mallinckrodt C, Demitrack MA. Duloxetine in the treatment of depression: a double blind placebo controlled comparison with paroxetine. European Neuropsychopharmacology 2002;12:43‐4. - PubMed
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    1. Mallinckrodt C, Goldstein DJ, Lu Y, Detke M, Wiltse C, Demitrack MA. Duloxetine in the treatment of depression: a double blind placebo controlled comparison with Paroxetine. European Neuropsychopharmacology 2002;12(Suppl 3):S214. - PubMed
Higuchi 2009a {published data only}
    1. Higuchi T, Murasaki M, Kamijima K. Clinical evaluation of duloxetine in the treatment of major depressive disorder placebo and paroxetine controlled double‐blind comparative study. Japanese Journal of Clinical Psychopharmacology 2009;12:1613‐34.
ID#3327 (HMAQ B) {unpublished data only}
    1. Eli Lilly. Duloxetine versus placebo in the treatment of major depression [Trial 3327b, HMAQ B]. http://www.clinicalstudyresults.org/documents/company‐study_138_0.pdf [accessed 5 October 2007, archived data on file].
ID#4091 (HMAT A) {unpublished data only}
    1. Eli Lilly. Duloxetine versus placebo and paroxetine in the acute treatment of major depression, Study Group A [Trial 4091a, HMAT A]. http://www.clinicalstudyresults.org/documents/company‐study_170_0.pdf [accessed 5 October 2007, archived data on file].
ID#7999 (HMCQ) {unpublished data only}
    1. Eli Lilly. Duloxetine versus venlafaxine extended release in the treatment of major depressive disorder [Trial 7999, HMCQ]. http://www.clinicalstudyresults.org/documents/company‐study_3108_0.pdf [accessed 1 December 2010, archived data on file].
Khan 2007 (SCT‐MD‐23) {published data only}
    1. Forest Laboratories. Double‐blind study of escitalopram in adult patients with major depressive disorder [Trial SCT‐MD‐23]. Forest Laboratories Clinical Trial Registry [http://www.forestclinicaltrials.com/] 2007.
    1. Khan A, Bose A, Alexopoulos GS, Gommoll C, Li D, Gandhi C. Double‐blind comparison of escitalopram and duloxetine in the acute treatment of major depressive disorder. Clinical Drug Investigation 2007;27(7):481‐92. - PubMed
Lee 2007 (HMCV) {published data only}
    1. Eli Lilly. Duloxetine versus paroxetine in the acute treatment of major depression [Trial 6937]. http://www.clinicalstudyresults.org/documents/company‐study_2402_0.pdf [accessed 5 October 2007, archived data on file].
    1. Lee P, Shu L, Xu X, Wang CY, Lee MS, Liu CY, et al. Once‐daily duloxetine 60 mg in the treatment of major depressive disorder: multicenter, double‐blind, randomized, paroxetine‐controlled, non‐inferiority trial in China, Korea, Taiwan and Brazil. Psychiatry and Clinical Neurosciences 2007;61(3):295‐307. - PubMed
Nierenberg 2007 (HMCR) {published data only}
    1. Eli Lilly. Duloxetine versus escitalopram and placebo in the treatment of patients with major depression [Trial 7978, HMCR]. http://www.clinicalstudyresults.org/documents/company‐study_2182_0.pdf [accessed 5 October 2007, archived data on file].
    1. Nierenberg AA, Greist JH, Mallinckrodt CH, Prakash A, Sambunaris A, Tollefson GD, et al. 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 2007;23(2):401‐16. - PubMed
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Patel 2011 {published data only}
    1. Badyal DK, Khosla PP, Deswal RS, Matreja PS. Safety and efficacy of duloxetine versus venlafaxine in major depression in Indian patients. JK Science 2006;8(4):195‐9.
    1. Patel DM, Mehta HR, Shah SK, Srivastava AA. An open label randomized, comparative, parallel group, multicentric clinical trial to evaluate the safety and efficacy of duloxetine compared to venlafaxine in patients with major depression. Pharma Science Monitor: An International Journal of Pharmaceutical Sciences 2011;2(2):126‐40.
Perahia 2006 (HMAY B) {published data only}
    1. Eli Lilly. Duloxetine versus placebo and paroxetine in the treatment of major depression [ Trial 4298b, HMAYb]. http://www.clinicalstudyresults.org/documents/company‐study_1618_0.pdf [accessed 5 October 2007, archived data on file].
    1. Perahia DG, Wang F, Mallinckrodt CH, Walker DJ, Detke MJ. Duloxetine in the treatment of major depressive disorder: a placebo‐ and paroxetine‐controlled trial. European Psychiatry 2006;21(6):367‐78. - PubMed
Perahia 2008 (HMBU) {published and unpublished data}
    1. Eli Lilly. Duloxetine versus venlafaxine extended release in the treatment of major depressive disorder [Trial 6090, HMBU]. http://www.clinicalstudyresults.org/documents/company‐study_3107_0.pdf [accessed 19 August 2010, archived data on file].
    1. Perahia DG, Pritchett YL, Kajdasz DK, Bauer M, Jain R, Russell JM, et al. A randomized, double‐blind comparison of duloxetine and venlafaxine in the treatment of patients with major depressive disorder. Journal of Psychiatric Research 2008;42(1):22‐34. - PubMed
Tourian 2009 {published and unpublished data}
    1. Pfizer. A multicenter, randomized, double‐blind, placebo‐controlled, duloxetine‐referenced, parallel‐group study to evaluate the efficacy and safety of 2 fixed doses (50mg, 100mg) of desvenlafaxine sustained‐release tablets in adult outpatients with major depressive disorder [results]. ClinicalTrials.gov 2012. http://www.clinicaltrials.gov/ct2/show/results/NCT00384033.
    1. Tourian KA, Padmanabhan SK, Groark J, Brisard C, Farrington D. Desvenlafaxine 50 and 100 mg/d in the treatment of major depressive disorder: an 8‐week, phase III, multicenter, randomized, double‐blind, placebo‐controlled, parallel‐group trial and a post hoc pooled analysis of three studies. Clinical Therapeutics 2009;31(1):1405‐23. - PubMed
    1. Wyeth. Final report: a multicenter, randomized, double‐blind, placebo‐controlled, duloxetine‐referenced, parallel‐group study to evaluate the efficacy and safety of 2 fixed doses (50 mg, 100 mg) of desvenlafaxine sustained release tablets in adult outpatients with major depressive disorder. Synopsis based on final report. (Protocol 3151A1‐335) [NCT00384033]. Clinicalstudyresults.org [www.clinicalstudyresults.org] 2008 [accessed 28 March 2011, archived data on file].
Wade 2007 {published data only}
    1. H Lundbeck A/S. A double‐blind, randomised, multicenter, comparative study of escitalopram and duloxetine in outpatients with major depressive disorder [Trial 10990]. http://www.lundbecktrials.com/Data/PDFs/10990_CTRS_Final%20for%20upload_....
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References to studies excluded from this review

Badyal 2006 {published data only}
    1. Badyal DK, Khosla PP, Deswal RS, Matreja PS. Safety and efficacy of duloxetine versus venlafaxine in major depression in Indian patients. K Science 2006;8(4):195‐9.
Herrera‐Guzman 2009 {published data only}
    1. Herrera‐Guzman I, Gudayol‐Ferre E, Herrera‐Guzman D, Guardia‐Olmos J, Hinojosa‐Calvo E, Herrera‐Abarca JE. Effects of selective serotonin reuptake and dual serotonergic‐noradrenergic reuptake treatments on memory and mental processing speed in patients with major depressive disorder. Journal of Psychiatric Research 2009;43(9):855‐63. - PubMed
Higuchi 2009b {published data only}
    1. Higuchi T, Murasaki M, Kamijima. Clinical evaluation of duloxetine in the treatment of major depressive disorder: Superiority of study of 40 mg and 60 mg versus 5 mg. Rinsho Seishin Yakuri 2009;12:1595‐612.
ID#1126 (HMAI) {unpublished data only}
    1. Brunton S, Wang F, Edwards SB, Crucitti AS, Ossanna MJ, Walker DJ, et al. Profile of adverse events with duloxetine treatment: a pooled analysis of placebo‐controlled studies. Drug Safety: an international journal of medical toxicology and drug experience 2010;33(5):393‐407. - PubMed
    1. Eli Lilly. A double‐blind, placebo‐ and clomipramine‐controlled study in duloxetine patients with major depression [Trial 1126, HMAI]. http://www.clinicalstudyresults.org/documents/company‐study_4148_0.pdf [accessed 1 December 2010, archived data on file].
Lam 2008 {published data only}
    1. Lam RW, Andersen HF, Wade AG. Escitalopram and duloxetine in the treatment of major depressive disorder: a pooled analysis of two trials. International Clinical Psychopharmacology 2008;23(4):181‐7. - PubMed
Lam 2010 {published data only}
    1. Lam RW, Lonn SL, Despiegel N. Escitalopram versus serotonin noradrenaline reuptake inhibitors as second step treatment for patients with major depressive disorder: A pooled analysis. International Clinical Psychopharmacology 2010;25(4):199‐203. - PubMed
Murasaki 2009a {published data only}
    1. Murasaki M. Clinical evaluation of duloxetine in the treatment of depression and depressive state: Mianserin‐controlled double‐blind comparative study. Rinsho Seishin Yakuri 2009;12:1533‐48.
Murasaki 2009b {published data only}
    1. Murasaki M. Clinical evaluation of duloxetine in the treatment of depression and depressive state: Imipramine‐controlled double‐blind comparative study. Rinsho Seishin Yakuri 2009;12:1517‐31.
NCT00666757 {unpublished data only}
    1. Eli Lilly, Boehringer Ingelheim Pharmaceuticals. TRY FIRST: A 12‐week, randomized, open‐label trial of duloxetine versus generic SSRIs in the treatment of a severe depressive episode [NCT00666757]. ClinicalTrials.gov 2008. http://clinicaltrials.gov/ct2/show/NCT00666757.
    1. Martinez JM, Katon W, Greist JH, Kroenke K, Thase ME, Meyers AL, et al. A pragmatic 12‐week, randomized trial of duloxetine versus generic selective serotonin‐reuptake inhibitors in the treatment of adult outpatients in a moderate‐to‐severe depressive episode. International Clinical Psychopharmacology 2012;27(1):17‐26. - PubMed
NCT00810068 {unpublished data only}
    1. Eli Lilly. Comparison of two different treatment strategies in patients with major depressive disorder not exhibiting improvement on escitalopram treatment: early vs. delayed intervention strategy [NCT00810068; F1J‐EW‐HMGD; EU 2008‐002319‐42]. ClinicalTrials.gov 2008. http://clinicaltrials.gov/ct2/show/NCT00810069.
Perahia 2008 {published data only}
    1. Perahia DG, Pritchett YL, Kajdasz DK, Bauer M, Jain R, Russell JM. A randomized, double‐blind comparison of duloxetine and venlafaxine in the treatment of patients with major depressive disorder. Journal of Psychiatric Research 2008;42(1):22‐34. - PubMed
Romera 2010 {published data only}
    1. Romera I, Perez V, Menchon JM, Schacht A, Papen R, Neuhauser D. Early vs. delayed switch to duloxetine in patients with major depressive disorder not exhibiting early improvement with escitalopram: A double‐blind randomized study. International Journal of Psychiatry in Clinical Practice 2010;14:34.
SCT‐MD‐39 {unpublished data only}
    1. Asnis G, Tsai J, Mao Y. Fixed‐dose comparison of escitalopram and duloxetine in severely depressed patients. Poster presented at Collegium Internationale Neuro‐Psychopharmacologicum XXVI; July 15, 2008; Munich, Germany. 2008.
    1. Forest Laboratories. Fixed dose comparison of escitalopram to an active comparator in severely depressed patients [Trial SCT‐MD‐39]. Forset Laboratories Clinical Trial Registry [www.forestclinicaltrials.com] 2006.
Serafini 2010 {published data only}
    1. Serafini G, Pompili M, Casale A, Mancini M, Innamorati M, Lester D. Duloxetine versus venlafaxine in the treatment of unipolar and bipolar depression. Clinica Terapeutica 2010;161(4):321‐7. - PubMed
Tsutsui 2009 {published data only}
    1. Tsutsui S. Clinical evaluation of duloxetine in the treatment of depression and depressive state: Trazodone‐controlled double‐blind comparative study. Rinsho Seishin Yakuri 2009;12:1549‐63.

References to studies awaiting assessment

Joubert 1997 {published data only}
    1. Joubert AF, du Plessis AD, Faries D, Gagiano CA. High Placebo response rate versus clinical impression with the new antidepressant Duloxetine. Sith World Congress of Biological Psychiatry. 1997 June 22‐27; Nice.
NCT00635219 {unpublished data only}
    1. Baldwin D, Loft H, Dragheim M. A randomised, double‐blind, placebo controlled, duloxetine‐referenced, fixed‐dose study of three dosages of Lu AA21004 in MDD treatment [conference abstract]. European Neuropsychopharmacology [abstracts of the 24th Congress of the European College of Neuropsychopharmacology, ECNP; 2011 Sept 3‐7, Paris France] 2011;21((Suppl 3)):S390. - PubMed
    1. Baldwin DS, Loft H, Dragheim M. A randomised, double‐blind, placebo controlled,duloxetine‐referenced, fixed‐dose study of threedosages of Lu AA21004 in acute treatment of majordepressive disorder (MDD). European Neuropsychopharmacology. 2011:doi:10.1016/j.euroneuro.2011.11.008. - PubMed
    1. H Lundbeck A/S . A randomised, double‐blind, parallel‐group, placebo‐controlled, duloxetine‐referenced, fixed‐dose study evaluating the efficacy and safety of three dosages of Lu AA21004, in acute treatment of major depressive disorder [NCT00635219]. ClinicalTrials.gov 2008. http://www.clinicaltrials.gov/ct2/show/NCT00635219.
NCT00672620 {unpublished data only}
    1. H Lundbeck A/S. A randomized, double‐blind, parallel‐group, placebo‐controlled, active‐referenced, fixed‐dose study comparing the efficacy and safety of 2 doses of Lu AA21004 in acute treatment of adults with major depressive disorder [NCT00672620]. ClinicalTrials.gov 2008. http://www.clinicaltrials.gov/ct2/show/NCT00672620.
NCT00811252 {unpublished data only}
    1. H Lundbeck A/S. Randomised, double‐blind, parallel‐group, placebo‐controlled, duloxetine‐referenced, fixed dose study comparing the efficacy and safety of Lu AA21004 in acute treatment of major depressive disorder in elderly patients [NCT00811252]. ClinicalTrials.gov 2008. http://www.clinicaltrials.gov/ct2/show/NCT00811252.
    1. Katona C, Hansen T, Olsen CK. A randomized, double‐blind, placebo‐controlled, duloxetine‐referenced, fixed‐dose study comparing the efficacy and safety of Lu AA21004 in elderly patients with major depressive disorder. International Clinical Psychopharmacology 2012;27(4):215‐23. - PubMed
NCT01145755 {unpublished data only}
    1. AstraZeneca. A phase IIa, multi‐centre, randomized, double‐blind, double‐dummy, active and placebo controlled, parallel group study to assess the effectiveness and safety of AZD2066 after 6 weeks of treatment in patients with major depressive disorder ‐ D0475C00020. [NCT01145755]. ClinicalTrials.gov 2010. http://clinicaltrials.gov/ct2/show/NCT01145755.

References to ongoing studies

2008‐004642‐92 {unpublished data only}
    1. Servier Laboratories. Evaluation of efficacy and clinical benefit of agomelatine (25 to 50 mg/day) over a 6‐month treatment period in patients with major depressive disorder.A randomised, double‐blind, international multicentre study with parallel groups versus duloxetine (60 mg/day).Twenty‐four weeks of treatment. [Servier Trial CL3‐20098‐062; EudraCT Number: 2008‐004642‐92]. EU Clinical Trials Register [www.clinicaltrialsregister.eu/ctr‐search/] 2009.
NCT01140906 {unpublished data only}
    1. H Lundbeck A/S. A randomised, double‐blind, parallel‐group, placebo‐controlled, duloxetine‐referenced, fixed‐dose study evaluating the efficacy and safety of Lu AA21004 (15 and 20 mg/Day) in the acute treatment of adult patients with major depressive disorder [NCT01140906]. ClinicalTrials.gov 2010. http://clinicaltrials.gov/ct2/show/NCT01140906 2010.
NCT01153009 {unpublished data only}
    1. Takeda. A phase 3, randomized, double‐blind, parallel‐group, placebo‐controlled, duloxetine‐referenced, fixed‐dose study comparing the efficacy and safety of 2 doses (15 and 20 mg) of Lu AA21004 in acute treatment of adults with major depressive disorder [NCT01153009]. ClinicalTrials.gov 2010 http://clinicaltrials.gov/ct2/show/NCT01153009 2010.
NCT01288079 {unpublished data only}
    1. AstraZeneca. A phase IIb, randomized, double‐blind, placebo‐controlled, active controlled, parallel group, multicenter study to assess the safety and efficacy of 2 fixed dose groups of TC‐5214 (S‐mecamylamine) as monotherapy treatment in patients with major depressive disorder who exhibit an inadequate response to antidepressant therapy [NCT01288079; D4131C00001; EU 2010‐023816‐15]. http://www.clinicaltrials.gov/ct2/show/NCT01288079.

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