Hostname: page-component-586b7cd67f-gb8f7 Total loading time: 0 Render date: 2024-11-25T21:14:42.895Z Has data issue: false hasContentIssue false
  • English
  • Français

Perceptions of Efficacy, Safety, and Tolerability: Impact on Evaluating New Treatments

Published online by Cambridge University Press:  07 November 2014

Sidney Kennedy
Get access Rights & Permissions [Opens in a new window]

Extract

Efficacy, safety, and tolerability are primary parameters for evaluation of any pharmacologic treatment. However, in order to evaluate the effectiveness of a new treatment in everyday clinical practice, these parameters must be assessed in the context of a number of societal, patient, and methodological variables.

Type
Expert Panel Supplement
Information
CNS Spectrums , Volume 14 , Issue S5: Efficacy, Safety, and Tolerability Considerations in the Novel Treatment of Major Depressive Disorder , March 2009 , pp. 8 - 10
Copyright
Copyright © Cambridge University Press 2009

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

1.Nakane, Y, Jorm, AF, Yoshioka, K, Christensen, H, Nakane, H, Griffiths, KM. Public beliefs about causes and risk factors for mental disorders: a comparison of Japan and Australia. BMC Psychiatry. 2005;5:33.CrossRefGoogle ScholarPubMed
2.Cabassa, LJ, Lester, R, Zayas, LH. “It's like being in a labyrinth:” Hispanic immigrants’ perceptions of depression and attitudes toward treatments. J Immigr Minor Health. 2007;9(1):1–16.CrossRefGoogle Scholar
3.Turner, EH, Matthews, AM, Linardatos, E, Tell, RA, Rosenthal, R. Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med. 2008;358(3):252–260.CrossRefGoogle ScholarPubMed
4.Kirsch, I, Deacon, BJ, Huedo-Medina, TB, Scoboria, A, Moore, TJ, Johnson, BT. Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration. PLoS Med. 2008;5(2):e45.CrossRefGoogle ScholarPubMed
5.National Institute for Clinical Excellence. Depression: management of depression in primary and secondary care. London, England: National Institiute for Clinical Excellence; 2004. Clinical practice guideline No. 23.Google Scholar
6.Ravindran, L, Kennedy, SH. Are antidepressants as effective as claimed? Yes, but…. Can J Psychiatry. 2007;52(2):98–99.CrossRefGoogle Scholar
7.McIntyre, RS, Konarski, JZ, Mancini, DA, et al. Measuring the severity of depression and remission in primary care: validation of the HAMD-7 scale. CMAJ. 2005;173(11):1327–1334.CrossRefGoogle ScholarPubMed
8.Khan, A, Brodhead, AE, Kolts, RL, Brown, WA. Severity of depressive symptoms and response to antidepres-sants and placebo in antidepressant trials. J Psychiatric Res. 2005;39(2):145–150.CrossRefGoogle Scholar
9.Khan, A, Schwartz, K, Kolts, RL, Ridgway, D, Lineberry, C. Relationship between depression severity entry criteria and antidepressant clinical trial outcomes. Biol Psychiatry. 2007;62(1):65–71.CrossRefGoogle ScholarPubMed
10.Kennedy, SH, Andersen, HF, Lam, RW. Efficacy of escitalopram in the treatment of major depressive disorder compared with conventional selective serotonin reuptake inhibitors and venlafaxine XR: a meta-analysis. J Psychiatry Neurosci. 2006;31(2):122–131.Google ScholarPubMed
11.Lam, RW, Andersen, HF. The influence of baseline severity on efficacy of escitalopram and citalopram in the treatment of major depressive disorder: an extended analysis. Pharmacopsychiatry. 2006;39(5):180–184.CrossRefGoogle ScholarPubMed
12.Thase, ME, Kennedy, SH. All for one or one for all – assessing the true treatment effet of active treatment versus placebo therapy in patients with severe MDD. Poster presented at: 20th Congress of the European College of Neuropsychopharmacology; October 13–17, 2007; Vienna, Austria.CrossRefGoogle Scholar
13.Olfson, M, Shaffer, D, Marcus, SC, Greenberg, T. Relationship between antidepressant medication treatment and suicide in adolescents. Arch Gen Psychiatry. 2003;60(10):978–982.CrossRefGoogle ScholarPubMed
14.Simon, GE, Savarino, J. Suicide attempts among patients starting depression treatment with medications or psychotherapy. Am J Psychiatry. 2007;164:1029–1034.CrossRefGoogle ScholarPubMed
15.Hammad, TA, Laughren, T, Racoosin, J. Suicidality in pediatric patients treated with antidepressant drugs. Arch Gen Psychiatry. 2006;63(3):332–339.CrossRefGoogle ScholarPubMed
16.Gibbons, RD, Brown, CH, Hur, K, et al. Early evidence on the effects of regulators’ suicidality warnings on SSRI prescriptions and suicide in children and adolescents. Am J Psychiatry. 2007;164(9):1356–1363.CrossRefGoogle ScholarPubMed
17.Katz, LY, Kozyrskyj, AL, Prior, HJ, Enns, MW, Cox, BJ, Sareen, J. Effect of regulatory warnings on antidepressant prescription rates, use of health services and outcomes among children, adolescents and young adults. CMAJ. 2008;178(8):1005–1011.CrossRefGoogle ScholarPubMed
18.Luqmani, R, Hennell, S, Estrach, C, et al. British Society for Rheumatology and British Health Professionals in Rheumatology Guideline for the Management of Rheumatoid Arthritis (The first 2 years). Rheumatology (Oxford). 2006;45:1–16.CrossRefGoogle Scholar
19.Caspi, A, Sugden, K, Moffitt, TE, et al. Influence of life stress on depression: moderation by a polymorphism in the 5-HTT gene. Science. 2003;301(5631):386–389.CrossRefGoogle ScholarPubMed
20.Munafò, MR, Brown, SM, Hariri, AR. Serotonin transporter (5-HTTLPR) genotype and amygdala activation: a meta-analysis. Biol Psychiatry. 2008;63(9):852–857.CrossRefGoogle ScholarPubMed
21.Thase, ME, Entsuah, AR, Rudolph, RI. Remission rates during treatment with venlafaxine or selective serotonin reuptake inhibitors. Br J Psychiatry. 2001;178:234–241.CrossRefGoogle ScholarPubMed
22.Nemeroff, CB, Entsuah, R, Benattia, I, Demitrack, M, Sloan, DM, Thase, ME. Comprehensive analysis of remission (COMPARE) with venlafaxine versus SSRIs. Biol Psychiatry. 2008;63(4):424–434.CrossRefGoogle ScholarPubMed
23.Anderson, IM. Commentary on ‘Re-evaluation of the efficacy and tolerability of venlafaxine versus SSRI: meta-analysis’ by Weinmann et al. Psychopharmacology (Berl). 2008;196(4):521–522.CrossRefGoogle Scholar
24.Weinmann, S, Becker, T, Koesters, M. Re-evaluation of the efficacy and tolerability of venlafaxine vs SSRI: meta-analysis. Psychopharmacol. 2008;196(4):511–520.CrossRefGoogle ScholarPubMed
25.Papakostas, GI. Tolerability of modern antidepressants. J Clin Psychiatry. 2008;69(suppl E1):8–13.Google ScholarPubMed
26.Bonierbale, M, Lançon, C, Tignol, J. The ELIXIR study: evaluation of sexual dysfunction in 4557 depressed patients in France. Curr Med Res Opin. 2003;19(2):114–124.CrossRefGoogle ScholarPubMed
27.Hu, XH, Bull, SA, Hunkeler, EM. Incidence and duration of side effects and those rated as bothersome with selective serotonin reuptake inhibitor treatment for depression: patient report versus physician estimate. J Clin Psychiatry. 2004;65(7):959–965.CrossRefGoogle ScholarPubMed