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Review
. 2012 Dec 12;12(12):CD009138.
doi: 10.1002/14651858.CD009138.pub2.

Amitriptyline versus placebo for major depressive disorder

Claudia Leucht  1 , Maximilian Huhn, Stefan Leucht
Affiliations
Review

Amitriptyline versus placebo for major depressive disorder

Claudia Leucht et al. Cochrane Database Syst Rev. .

Abstract

Background: Amitriptyline is a tricyclic antidepressant that was synthesised in 1960 and introduced as early as 1961 in the USA, but is still regularly used. It has also been frequently used as an active comparator in trials on newer antidepressants and can therefore be called a 'benchmark' antidepressant. However, its efficacy and safety compared to placebo in the treatment of major depression has not been assessed in a systematic review and meta-analysis.

Objectives: To assess the effects of amitriptyline compared to placebo or no treatment for major depressive disorder in adults.

Search methods: We searched the Cochrane Depression, Anxiety and Neurosis Group's Specialised Register (CCDANCTR-Studies and CCDANCTR-References) to August 2012. This register contains relevant randomised controlled trials from: The Cochrane Library (all years), EMBASE (1974 to date), MEDLINE (1950 to date) and PsycINFO (1967 to date). The reference lists of reports of all included studies were screened and manufacturers of amitriptyline contacted for details of additional studies.

Selection criteria: All randomised controlled trials (RCTs) comparing amitriptyline with placebo or no treatment in patients with major depressive disorder as diagnosed by operationalised criteria.

Data collection and analysis: Two review authors independently extracted data. For dichotomous data, we calculated the odds ratio (OR) with 95% confidence intervals (CI). We analysed continuous data using standardised mean differences (with 95% CI). We used a random-effects model throughout.

Main results: The review includes 39 trials with a total of 3509 participants. Study duration ranged between three and 12 weeks. Amitriptyline was significantly more effective than placebo in achieving acute response (18 RCTs, n = 1987, OR 2.67, 95% CI 2.21 to 3.23). Significantly fewer participants allocated to amitriptyline than to placebo withdrew from trials due to inefficacy of treatment (19 RCTs, n = 2017, OR 0.20, 95% CI 0.14 to 0.28), but more amitriptyline-treated participants withdrew due to side effects (19 RCTs, n = 2174, OR 4.15, 95% CI 2.71 to 6.35). Amitriptyline also caused more anticholinergic side effects, tachycardia, dizziness, nervousness, sedation, tremor, dyspepsia, sedation, sexual dysfunction and weight gain. In subgroup and meta-regression analyses the results of the primary outcome were robust towards publication year (1971 to 1997), mean participant age at baseline, mean amitriptyline dose, study duration in weeks, pharmaceutical sponsor, inpatient versus outpatient setting and two-arm versus three-arm design. However, higher severity at baseline was associated with higher superiority of amitriptyline (P = 0.02), while higher responder rates in the placebo groups were associated with lower superiority of amitriptyline (P = 0.05). The results of the primary outcome were rather homogeneous, reflecting comparability of the trials. However, methods of randomisation, allocation concealment and blinding were usually poorly reported. Not all studies used intention-to-treat analyses and in many of them standard deviations were not reported and often had to be imputed. Funnel plots suggested a possible publication bias, but the trim and fill method did not change the overall effect size much (seven adjusted studies, OR 2.64, 95% CI 2.24 to 3.10).

Authors' conclusions: Amitriptyline is an efficacious antidepressant drug. It is, however, also associated with a number of side effects. Degree of placebo response and severity of depression at baseline may moderate drug-placebo efficacy differences.

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Conflict of interest statement

Stefan Leucht: has received honoraria for consulting/advisory boards from Alkermes, BristolMyersSquibb, EliLilly, Janssen, Johnson&Johnson, Medavante, Roche, lecture honoraria from AstraZeneca, BristolMyersSquibb, EliLilly, EssexPharma, Janssen, Johnson&Johnson, Lundbeck Institute, Pfizer and SanofiAventis, and EliLilly has provided medication for a trial with SL as the primary investigator.

Claudia Leucht: is Stefan Leucht's wife. Therefore, his conflicts of interest in part also apply to her. She has no other conflicts of interest.

Maximilian Huhn: none to declare.

Figures

1
1
Study flow diagram.
2
2
'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
4
4
Forest plot of comparison: 1 Amitriptyline versus placebo, outcome: 1.1 Response.
5
5
6
6
Funnel plot of comparison: 1 Amitriptyline versus placebo, outcome: 1.1 Response.
7
7
1.1
1.1. Analysis
Comparison 1 Amitriptyline versus placebo, Outcome 1 Response.
1.2
1.2. Analysis
Comparison 1 Amitriptyline versus placebo, Outcome 2 Remission.
1.3
1.3. Analysis
Comparison 1 Amitriptyline versus placebo, Outcome 3 Mean severity of depression ‐ change scores.
1.4
1.4. Analysis
Comparison 1 Amitriptyline versus placebo, Outcome 4 Mean severity of depression ‐ endpoint scores.
1.5
1.5. Analysis
Comparison 1 Amitriptyline versus placebo, Outcome 5 Drop‐out: total.
1.6
1.6. Analysis
Comparison 1 Amitriptyline versus placebo, Outcome 6 Drop‐out: due to inefficacy.
1.7
1.7. Analysis
Comparison 1 Amitriptyline versus placebo, Outcome 7 Drop‐out: due to adverse events.
1.8
1.8. Analysis
Comparison 1 Amitriptyline versus placebo, Outcome 8 Side effects ‐ total number of patients experiencing at least one side effect.
1.9
1.9. Analysis
Comparison 1 Amitriptyline versus placebo, Outcome 9 Side effects ‐ anticholinergic: any anticholinergic effects (dry mouth, constipation, visual disturbances).
1.10
1.10. Analysis
Comparison 1 Amitriptyline versus placebo, Outcome 10 Side effects ‐ anticholinergic: constipation.
1.11
1.11. Analysis
Comparison 1 Amitriptyline versus placebo, Outcome 11 Side effects ‐ anticholinergic: dry mouth.
1.12
1.12. Analysis
Comparison 1 Amitriptyline versus placebo, Outcome 12 Side effects ‐ anticholinergic: nasal congestion.
1.13
1.13. Analysis
Comparison 1 Amitriptyline versus placebo, Outcome 13 Side effects ‐ anticholinergic: urination problems.
1.14
1.14. Analysis
Comparison 1 Amitriptyline versus placebo, Outcome 14 Side effects ‐ anticholinergic: vision problems (amblyopia, blurred vision).
1.15
1.15. Analysis
Comparison 1 Amitriptyline versus placebo, Outcome 15 Side effects ‐ cardiovascular: hypertension.
1.16
1.16. Analysis
Comparison 1 Amitriptyline versus placebo, Outcome 16 Side effects ‐ cardiovascular: hypotension.
1.17
1.17. Analysis
Comparison 1 Amitriptyline versus placebo, Outcome 17 Side effects ‐ cardiovascular: lightheadedness.
1.18
1.18. Analysis
Comparison 1 Amitriptyline versus placebo, Outcome 18 Side effects ‐ cardiovascular: palpitations.
1.19
1.19. Analysis
Comparison 1 Amitriptyline versus placebo, Outcome 19 Side effects ‐ cardiovascular: tachycardia.
1.20
1.20. Analysis
Comparison 1 Amitriptyline versus placebo, Outcome 20 Side effects ‐ central nervous: agitation.
1.21
1.21. Analysis
Comparison 1 Amitriptyline versus placebo, Outcome 21 Side effects ‐ central nervous: amnesia.
1.22
1.22. Analysis
Comparison 1 Amitriptyline versus placebo, Outcome 22 Side effects ‐ central nervous: confusion.
1.23
1.23. Analysis
Comparison 1 Amitriptyline versus placebo, Outcome 23 Side effects ‐ central nervous: disco‐ordination.
1.24
1.24. Analysis
Comparison 1 Amitriptyline versus placebo, Outcome 24 Side effects ‐ central nervous: dizziness.
1.25
1.25. Analysis
Comparison 1 Amitriptyline versus placebo, Outcome 25 Side effects ‐ central nervous: headache.
1.26
1.26. Analysis
Comparison 1 Amitriptyline versus placebo, Outcome 26 Side effects ‐ central nervous: increased activity.
1.27
1.27. Analysis
Comparison 1 Amitriptyline versus placebo, Outcome 27 Side effects ‐ central nervous: insomnia.
1.28
1.28. Analysis
Comparison 1 Amitriptyline versus placebo, Outcome 28 Side effects ‐ central nervous: nervousness.
1.29
1.29. Analysis
Comparison 1 Amitriptyline versus placebo, Outcome 29 Side effects ‐ central nervous: sedation/sleepiness/somnolence/drowsiness.
1.30
1.30. Analysis
Comparison 1 Amitriptyline versus placebo, Outcome 30 Side effects ‐ central nervous: tremor.
1.31
1.31. Analysis
Comparison 1 Amitriptyline versus placebo, Outcome 31 Side effects ‐ dermal: rash.
1.32
1.32. Analysis
Comparison 1 Amitriptyline versus placebo, Outcome 32 Side effects ‐ dermal: sweating.
1.33
1.33. Analysis
Comparison 1 Amitriptyline versus placebo, Outcome 33 Side effects ‐ gastrointestinal: anorexia.
1.34
1.34. Analysis
Comparison 1 Amitriptyline versus placebo, Outcome 34 Side effects ‐ gastrointestinal: diarrhoea.
1.35
1.35. Analysis
Comparison 1 Amitriptyline versus placebo, Outcome 35 Side effects ‐ gastrointestinal: dyspepsia.
1.36
1.36. Analysis
Comparison 1 Amitriptyline versus placebo, Outcome 36 Side effects ‐ gastrointestinal: gastralgia.
1.37
1.37. Analysis
Comparison 1 Amitriptyline versus placebo, Outcome 37 Side effects ‐ gastrointestinal: increased appetite.
1.38
1.38. Analysis
Comparison 1 Amitriptyline versus placebo, Outcome 38 Side effects ‐ gastrointestinal: nausea.
1.39
1.39. Analysis
Comparison 1 Amitriptyline versus placebo, Outcome 39 Side effects ‐ gastrointestinal: vomiting.
1.40
1.40. Analysis
Comparison 1 Amitriptyline versus placebo, Outcome 40 Side effects ‐ gastrointestinal: weight gain.
1.41
1.41. Analysis
Comparison 1 Amitriptyline versus placebo, Outcome 41 Side effects ‐ general: fatigue/asthenia/slowed down.
1.42
1.42. Analysis
Comparison 1 Amitriptyline versus placebo, Outcome 42 Side effects ‐ sexual: impotence.
1.43
1.43. Analysis
Comparison 1 Amitriptyline versus placebo, Outcome 43 Side effects ‐ sexual: any sexual dysfunction.
1.44
1.44. Analysis
Comparison 1 Amitriptyline versus placebo, Outcome 44 Subgroup analysis: industry sponsored ‐ response to treatment.
1.45
1.45. Analysis
Comparison 1 Amitriptyline versus placebo, Outcome 45 Subgroup analysis: inpatient versus outpatient studies ‐ response to treatment.
1.46
1.46. Analysis
Comparison 1 Amitriptyline versus placebo, Outcome 46 Subgroup analysis: two‐arms versus three‐arms studies ‐ response to treatment.
1.47
1.47. Analysis
Comparison 1 Amitriptyline versus placebo, Outcome 47 Sensitivity analysis: devoid of studies calculated with imputed statistic methods ‐ response to treatment.
1.48
1.48. Analysis
Comparison 1 Amitriptyline versus placebo, Outcome 48 Sensitivity analysis: fixed instead of random‐effects model ‐ response to treatment.
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    1. Downing RW, Rickels K. Predictors of amitriptyline response in outpatient depressives. Journal of Nervous and Mental Disease 1972;154(4):248‐63. [CN‐00007057] - PubMed
Downing 1973 {published data only}
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Downing 1979 {published data only}
    1. Downing RW, Rickels K, Rickels LA, Downing D. Nonspecific factors and side effect complaints. Factors affecting the incidence of drowsiness in drug and placebo treated anxious and depressed outpatients. Acta Psychiatrica Scandinavica 1979;60(5):438‐48. - PubMed
Downing 1983 {published data only}
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Ellingson 1973 {published data only}
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Fisch 1992 {published data only}
    1. Fisch C, Knoebel SB. Electrocardiographic findings in sertraline depression trials. Drug Investigations 1992;4(4):305‐12.
Friedman 1974 {published data only}
    1. Friedman AS. Drug and family therapy in depressed outpatients. Psychopharmacology Bulletin 1974;10:18‐9.
Friedman 1975 {published data only}
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Friedman 1976 {published data only}
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Friedman 1980 {published data only}
    1. Friedman J, McCallum P, Meares R. Stimulus intensity control in depression: a study of the comparative effect of doxepin and amitriptyline on cortical evoked potentials.. Australian and New Zealand Journal of Psychiatry 1980;14(2):115‐9. - PubMed
Garry 1963 {published data only}
    1. Garry J, Leonard TJ. Trial of amitriptyline in chronic depression. British Journal of Psychiatry 1963;109:54‐5. - PubMed
Gomez 1968 {published data only}
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Guy 1982 {published data only}
    1. Guy W, Ban TA, McEvoy JP, Petrie WM, Wilson WH, Schaffer JD. A collaborative study of a new antidepressant, viloxazine, in neurotic and endogenous depressives. International Pharmacopsychiatry 1982;17(1):36‐42. - PubMed
Hazell 1995 {published data only}
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Hecht 1986 {published data only}
    1. Hecht Orzack M, Cole JO, Friedman L, Bird M, McEachern J. Weight changes in antidepressants: a comparison of amitriptyline and trazodone. Neuropsychobiology 1986;15(Suppl 1):28‐30. - PubMed
Hollister 1964 {published data only}
    1. Hollister LE, Overall JE, Johnson M, Pennington V, Katz G, Shelton J. Controlled comparison of imipramine, amitriptyline and placebo in hospitalised depressed patients. Journal of Nervous and Mental Disease 1964;139(4):370‐5. - PubMed
Houston 1983 {published data only}
    1. Houston J, Berg I, Butler A, McGuire R. Amitriptyline for depressed women with young children in general practice. British Journal of Psychiatry 1983;142:103‐4. - PubMed
Hussain 1970 {published data only}
    1. Hussain Z. Drugs in depressive illness. British Medical Journal 1970;1(707):482. - PMC - PubMed
Imlah 1985 {published data only}
    1. Imlah NW. An evaluation of alprazolam in the treatment of reactive or neurotic (secondary) depression. British Journal of Psychiatry 1985;146:515‐9. - PubMed
Itil 1972 {published data only}
    1. Itil TM, Cora R, Hsu W, Gig E, Saletu B. Clinical, toxicological and electroencephalographical effects of a new tricyclic antidepressant, OI‐77. Arzneimittelforschung 1972;22(12):2063‐6. - PubMed
Jacobson 1978 {published data only}
    1. Jacobson AF. Doctor‐patient concordance in a placebo‐controlled trial of limbitrol versus its components. Psychopharmacology Bulletin 1978;14(3):61‐3. - PubMed
Kasper 1995 {published data only}
    1. Kasper S. Clinical efficacy of mirtazapine: a review. 8th European College of Neuropsychopharmacology Congress, Venice, Italy. 30th September ‐ 4th October. 1995.
Kasper 1997 {published data only}
    1. Kasper S. Mirtazapine vs amitriptyline and placebo in the treatment of severely depressed patients. 10th European College of Neuropsychopharmacology Congress, Vienna, Austria. 13th ‐ 17th September. 1997. - PubMed
Kasper 1997a {published data only}
    1. Kasper S. Efficacy of antidepressants in the treatment of severe depression: the place of mirtazapine. Journal of Clinical Psychopharmacology 1997;17(Suppl 1):19S‐28S. - PubMed
Kiev 1974 {published data only}
    1. Kiev A. The role of chemotherapy in managing potentially suicidal patients. Diseases of the Nervous System 1974;35(3):108‐11. - PubMed
Klerman 1974 {published data only}
    1. Klerman GL, Dimascio A, Weissman M, Prusoff B, Paykel ES. Treatment of depression by drugs and psychotherapy. American Journal of Psychiatry 1974;131(2):186‐91. - PubMed
Laakmann 1995 {published data only}
    1. Laakmann G, Faltermaier‐Temizel M, Bossert‐Zaudig S, Baghai T, Lorkowski G. Treatment of depressive outpatients with lorazepam, alprazolam, amitriptyline and placebo. Psychopharmacology 1995;120(1):109‐15. - PubMed
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Lipsedge 1970 {published data only}
    1. Lipsedge MS, Rees WL, Pike DJ. A double‐blind comparison of dothiepin and amitriptyline for the treatment of depression with anxiety. Psychopharmacologica 1971;19:153‐62. - PubMed
Malitz 1971 {published data only}
    1. Malitz S, Kanzler M. Are antidepressants better than placebo?. American Journal of Psychiatry 1971;127(12):1605‐11. - PubMed
Master 1963 {published data only}
    1. Master RS. Amitriptyline in depressive states. A controlled trial in India. British Journal of Psychiatry 1963;109:826‐9. - PubMed
McCallum 1975 {published data only}
    1. McCallum P, Meares R. A controlled trial of maprotiline (Ludiomil) in depressed outpatients. Medical Journal of Australia 1975;2(10):392‐3. - PubMed
McDonald 1966 {published data only}
    1. McDonald IM, Perkins M, Marjerrison G, Podilsky M. A controlled comparison of amitriptyline and electroconvulsive therapy in the treatment of depression. American Journal of Psychiatry 1966;122(12):1427‐31. - PubMed
McLean 1992 {published data only}
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Moll 1990 {published data only}
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Möller 1993 {published data only}
    1. Möller HJ, Berzewski H, Eckmann F, Gonzalves N, Kissling W, Knorr W, et al. Double‐blind multicenter study of paroxetine and amitriptyline in depressed inpatients. Pharmacopsychiatry 1993;26:75‐8. - PubMed
Montgomery 1980b {published data only}
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Montgomery 1998 {published data only}
    1. Montgomery SA, Reimitz PE, Zivkov M. Mirtazapine versus amitriptyline in the long‐term treatment of depression: a double‐blind placebo‐controlled study. International Clinical Psychopharmacology 1998;13(2):63‐73. - PubMed
Morakinyo 1970 {published data only}
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Othmer 1983 {published data only}
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Othmer 1988 {published data only}
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Paykel 1973c {published data only}
    1. Paykel ES, Prusoff BA, Klerman GL, Haskell D, DiMascio A. Clinical response to amitriptyline among depressed women. Journal of Nervous and Mental Disease 1973;156(3):149‐65. [CN‐00008451] - PubMed
Podobnikar 1966 {published data only}
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Prusoff 1974 {published data only}
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Rampello 1995 {published data only}
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Rickels 1970 {published data only}
    1. Rickels K, Gordon PE, Jenkins BW, Perloff M, Sachs T, Stepansky W. Drug treatment in depressive illness. Diseases of the Nervous System 1970;31:30‐42. - PubMed
Rickels 1970b {published data only}
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Rickels 1974 {published data only}
    1. Rickels K, Csanalosi I, Chung HR, Case WG, Pereira‐Ogan A, Downing RW. Amitriptyline in anxious‐depressed outpatients: a controlled study. American Journal of Psychiatry 1974;131(1):25‐30. - PubMed
Rickels 1981 {published data only}
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Rockliff 1971 {published data only}
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Rosenberg 1974 {published data only}
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Schou 1979 {published data only}
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Skarbek 1962 {published data only}
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Skarbek 1963 {published data only}
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Spiker 1988 {published data only}
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Stabl 1989 {published data only}
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Stahl 1997 {published data only}
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Stein 1980 {published data only}
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Taverna 1969 {published data only}
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Taylor 1993 {published data only}
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Wallerstein 1967 {published data only}
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Warner 1988 {published data only}
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Welner 1980 {published data only}
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Wilson 1982 {published data only}
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Zivkov 1995 {published data only}
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References to studies awaiting assessment

Kahn 2008 {published data only}
    1. Kahn AY, Catterson ML, Preskorn SH. Double‐blind cross‐over study of mirtazapine, amitriptyline and placebo in patients with major depressive disorder. Directions in Psychiatry 2008;28:15‐20.

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