Socio-demographic features of participants in randomized con-trolled trials for major depression: generalizability and individu-alization.

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Published: Jun 30, 2011
DOI: https://doi.org/10.5750/ijpcm.v1i2.67

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Rosalind ven der Lem
Leiden University Medical Center/Rivierduinen, Leiden, The Netherlands
Purdey M. Stamsnieder
Medical Center Rijssen, Rijssen, The Netherlands.
Nic J.A. van der Wee
Psychiatrist, Department of Psychiatry, Leiden University Medical Center and Leiden Institute for Brain and Cognition, Leiden, The Netherlands.
Tineke van Veen
Epidemiologist, Department of Psychiatry, Leiden University Medical Center, Leiden, The Netherlands.
Frans G. Zitman
Professor and Head of Department of Psychiatry, Leiden University Medical Center, Leiden, The Netherlands.

Abstract

Rationale, Aims and Objectives: It is important for clinicians to know to what extent the results of randomized controlled trials (RCTs) are generalizable to their psychiatric practice, since RCTs are considered to be the most reliable source of evidence for treatment guideline development. Furthermore, it is important to know whether results from individual randomised controlled trials (RCTs) can be directly compared to each other.  Socio-demographic and socio-economic (SES) features influence treatment-outcome in major depressive disorder (MDD). Differences in (reporting of) SES features of  participants in RCTs will hamper comparison and jeopardise the external validity (generalizability) of their results. We explored the reporting of SES features in RCTs for depression.Methods: We selected 45 antidepressant efficacy trials (AETs) and 19 psychotherapy efficacy trials (PETs). We listed the reported socio-demographic and -economic features.Results: Reporting on SES-features was very diverse and often limited. Especially important SES features like educational level, socio-economic status and income were reported insufficiently. The mean age of RCT participants in MDD trials was 41 years. Participants are predominantly female (62%) and white (89%). Of the participants 61% were employed and 45% of the participants were married/cohabitating.Conclusions: Standardisation of reporting on socio-demographic and socio-economic status is needed to adequately judge the generalizability of RCTs to daily practice and to  facilitate comparisons within the body of RCTs in order to move increasingly towards more individualized and person-centered models of clinical practice.

Article Details

Issue
Vol. 1 No. 2 (2011): June
Section
Regular Articles
Author Biographies

Rosalind ven der Lem, Leiden University Medical Center/Rivierduinen, Leiden, The Netherlands

Psychiatrist, Deparment of Psychiatry, Leiden University Medical Center/Rivierduinen, Leiden, The Netherlands.

Purdey M. Stamsnieder, Medical Center Rijssen, Rijssen, The Netherlands.

Trainee in General Practice

Nic J.A. van der Wee, Psychiatrist, Department of Psychiatry, Leiden University Medical Center and Leiden Institute for Brain and Cognition, Leiden, The Netherlands.

Psychiatrist, Department of Psychiatry

Tineke van Veen, Epidemiologist, Department of Psychiatry, Leiden University Medical Center, Leiden, The Netherlands.

Epidemiologist, Department of Psychiatry,

Frans G. Zitman, Professor and Head of Department of Psychiatry, Leiden University Medical Center, Leiden, The Netherlands.

Professor and Head of Department of Psychiatry

References

. World Health Organisation. Depression 2010. Ref Type: Online Source.

. Badamgarav, E., Weingarten, S.R., Henning, J.M., Knight, K., Hasselblad, V., Gano, A, Jr. and Ofman, J.J. (2003). Effectiveness of disease management programs in depression: a systematic review. American Journal of Psy-chiatry 160(12), 2080-2090.

. Neumeyer-Gromen, A., Lampert, T., Stark, K. and Kallischnigg, G. (2004). Disease management programs for depression: a systematic review and meta-analysis of randomized controlled trials. Medical Care 42(12), 1211-1221.

. Trivedi, M.H., Claassen, C.A., Grannemann, B.D., Kashner, T.M., Carmody, T.J., Daly, E. and Kern, J.K. (2007). Assessing physicians’ use of treatment algorithms: Project IMPACTS study design and rationale. Contempo-rary Clinical Trials 28(2), 192-212.

. Fava, G.A., Ruini, C. and Rafanelli, C. (2005). Se-quential treatment of mood and anxiety disorders. Journal of Clinical Psychiatry 66(11), 1392-1400.

. IJff, M.A., Huijbregts, K.M., van Marwijk, H.W., Beekman, A.T., Hakkaart-van Roijen, L., Rutten, F.F., Unutzer, J. and van der Feltz-Cornelis, C.M. (2007). Cost-effectiveness of collaborative care including PST and an antidepressant treatment algorithm for the treatment of major depressive disorder in primary care; a randomised clinical trial. BMC Health Service Research 7, 34.

. Rothwell, P.M. (2005). External validity of random-ised controlled trials: “to whom do the results of this trial apply?”. Lancet 365(9453), 82-93.

. Wells, K.B. (1999). Treatment research at the cross-roads: the scientific interface of clinical trials and effec-tiveness research. American Journal of Psychiatry 156(1), 5-10.

. Tunis, S.R., Stryer, D.B. and Clancy, C.M. (2003). Practical clinical trials: increasing the value of clinical re-search for decision making in clinical and health policy. Journal of the American Medical Association 290(12), 1624-1632.

. Mulder, R.T., Frampton, C., Joyce, P.R. and Porter, R. (2003). Randomized controlled trials in psychiatry. Part II: their relationship to clinical practice. Australian and New Zealand Journal of Psychiatry 37(3), 265-269.

. Licht, R.W., Gouliaev, G., Vestergaard, P. and Fry-denberg, M. (1997). Generalisability of results from ran-domised drug trials. A trial on antimanic treatment. British Journal of Psychiatry 170, 264-267.

. Stewart, J.W., McGrath, P.J. and Quitkin, F.M. (1992). Can mildly depressed outpatients with atypical depression benefit from antidepressants ? American Jour-nal of Psychiatry 149(5), 615-619.

. Posternak, M.A., Zimmerman, M., Keitner G.I. and Miller, I.W. (2002). A re-evaluation of the exclusion crite-ria used in antidepressant efficacy trials. American Jour-nal of Psychiatry 159(2), 191-200.

. Zimmerman, M., Mattia, J.I. and Posternak, M.A. (2002). Are subjects in pharmacological treatment of de-pression representative of patients in routine clinical prac-tice ? American Journal of Psychiatry 159(3), 469-473.

. Partonen, T., Sihvo, S. and Lonnqvist, J.K. (1996). Patients excluded from an antidepressant efficacy trial. Journal of Clinical Psychiatry 57(12), 572-575.

. Wisniewski, S.R., Rush, A.J., Nierenberg, A.A. et al. (2009). Can phase III trial results of antidepressant medications be generalised to clinical practice ? A STAR*D report. American Journal of Psychiatry 166(5), 599-607.

. Van der Lem, R., van der Wee, N.J., van Veen, T. and Zitman, F.G. (2010). The generalizability of antidepressant efficacy trials to routine psychiatric out-patient practice. Psychological Medicine 16, 1-11.

. Riall, T.S., Reddy, D.M., Nealon, W.H. and Goodwin, J.S. (2008). The effect of age on short-term outcomes after pancreatic resection: a population-based study. Annals of Surgery 248(3), 459-467.

. Gibson, P.H., Croal, B.L., Cuthbertson, B.H., Gibson, G., Jeffrey, R.R., Buchan, K.G., El Shafei, H. and Hillis, G.S. (2009). Socio-economic status and early outcome from coronary artery bypass grafting. Heart 95(10), 793-798.

. Aberg-Wistedt, A., Agen, H., Ekselius, L., Bengtsson, F. and Akerblad, A.C. (2000). Sertraline versus paroxetine in major depression: clinical outcome after six months of continuous therapy. Journal of Clinical Psychopharmacology 20(6), 645-652.

. Kornstein, S.G., Schatzberg, A.F., Thase, M.E., Yonkers, K.A., McCullough, J.P., Keitner, G.I., Gelenberg, A.J., Davis, S.M., Harrison, W.M. and Keller, M.B. (2000). Gender differences in treatment response to sertraline versus imipramine in chronic depression. American Journal of Psychiatry 157(9), 1445-1452.

. Joyce, P.R., Mulder, R.T., Luty, S.E., Sullivan, P.F., McKenzie, J.M., Abbott, R.M. and Stevens, I.F. (2002). Patterns and predictors of remission, response and recov-ery in major depression treated with fluoxetine or nortrip-tyline. Australian and New Zealand Journal of Psychiatry 36(3), 384-391.

. Papakostas, G.I., Petersen, T., Mischoulon, D., Hughes, M.E., Spector, A.R., Alpert, J.E., Fava, M. and Nierenberg, A.A. (2003). Functioning and interpersonal relationships as predictors of response in treatment-resistant depression. Comprehensive Psychiatry 44(1), 44-50.

. Baca, E., Garcia-Garcia, M. and Porras-Chavarino, A. (2004). Gender differences in treatment response to sertraline versus imipramine in patients with non-melancholic depressive disorders. Progress in Neuropsy-chopharmacology and Biological Psychiatry 28(1), 57-65.

. Lowe,B., Schenkel, I., Bair, M.J. and Gobel, C. (2005). Efficacy, predictors of therapy response and safety of sertraline in routine clinical practice: prospective, open-label, non-interventional post-marketing surveillance study in 1878 patients. Journal of Affective Disorders 87(2-3), 271-279.

. Trivedi, M.H., Rush, A.J., Wisniewski, S.R. et al. (2006). Evaluation of outcomes with citalopram for de-pression using measurement-based care in STAR*D: im-plications for clinical practice. American Journal of Psy-chiatry 163(1), 28-40.

. Jarrett, R.B., Eaves, G.G., Grannemann, B.D. and Rush, A.J. (1991). Clinical, cognitive and demographic predictors of response to cognitive therapy for depression: a preliminary report. Psychiatry Research 37(3), 245-260.

. Sotsky, S.M., Glass, D.R., Shea, M.T., Pilkonis, P.A., Collins, J.F., Elkin, I., Watkins, J.T., Imber, S.D., Leber, W.R. and Moyer, J. (1991). Patient predictors of response to psychotherapy and pharmacotherapy: findings in the NIMH Treatment of Depression Collaborative Research Program. American Journal of Psychiatry 148(8), 997-1008.

. Thase, M.E., Reynolds, C.F. III, Frank, E., Simons, A.D., McGeary, J., Fasiczka, A.L., Garamoni, G.G., Jennings, J.R. and Kupfer, D.J. (1994). Do depressed men and women respond similarly to cognitive behaviour ther-apy? American Journal of Psychiatry 151(4), 500-505.

. Hollon, S.D., Derubeis, R.J., Evans, M.D., Wiemer, M.J., Garvey, M.J., Grove, W.M. and Tuason, V.B. (1992). Cognitive therapy and pharmacotherapy for depression. Singly and in combination. Archives of General Psychia-try 49(10), 774-781.

. Falconnier, L. (2009). Socio-economic status in the treatment of depression. American Journal of Orthopsy-chiatry 79(2), 148-158.

. Goekoop, J.G., Hoeksema, T., Knoppert-Van der Klein, E.A., Klinkhamer, R.A., Van Gaalen, H.A., Van Londen, L., de Weme, R. and Zwinderman, A.H. (1992). Multidimensional ordering of psychopathology. A factor-analytic study using the Comprehensive Psychopathologi-cal Rating Scale. Acta Psychiatrica Scandinavica 86(4), 306-312.

. Van, H.L., Schoevers, R.A. and Dekker, J. (2008). Predicting the outcome of antidepressants and psychother-apy for depression: a qualitative, systematic review. Har-vard Review of Psychiatry 16(4), 225-234.

. Croughan, J.L., Secunda, S.K., Katz, M.M., Robins, E., Mendels, J., Swann, A. and Harris-Larkin, B. (1988). Socio-demographic and prior clinical course characteristics associated with treatment response in depressed patients. Journal of Psychiatric Research 22(3), 227-237.

. Hoberman, H.M., Lewinsohn, P.M. and Tilson, M. (1988). Group treatment of depression: individual predic-tors of outcome. Journal of Consulting and Clinical Psy-chology 56(3), 393-398.

. Troisi, A., Pasini, A., Bersani, G., Grispini, A. and Ciani, N. (1989). Ethological predictors of amitriptyline response in depressed out-patients. Journal of Affective Disorders 17(2), 129-136.

. Blom, M.B., Spinhoven, P., Hoffman, T., Jonker, K., Hoencamp, E., Haffmans, P.M. and Van Dyck, R. (2007). Severity and duration of depression, not personality fac-tors, predict short term outcome in the treatment of major depression. Journal of Affective Disorders 104(1-3), 119-126.

. Blom, M.B., Hoek, H.W., Spinhoven, P., Hoencamp, E., Haffmans, P.M. and Van Dyck, R. (2010). Treatment of depression in patients from ethnic minority groups in The Netherlands. Transcultural Psychiatry 47(3), 473-490.

. Fortuna, L.R., Alegria, M. and Gao, S. (2010). Reten-tion in depression treatment among ethnic and racial mi-nority groups in the United States. Depression and Anxiety 27(5), 485-494.

. Givens, J.L., Houston, T.K., Van Voorhees, B.W., Ford, D.E. and Cooper, L.A. (2007). Ethnicity and prefer-ences for depression treatment. General Hospital Psychiatry 29(3), 182-191.

. Jones, E.E. (1982). Psychotherapists’ impressions of treatment outcome as a function of race. Journal of Clinical Psychology 38(4), 722-731.

. Lesser, I.M., Myers, H.F., Lin, K.M., Bingham, M.C., Joseph, N.T., Olmos, N.T., Schettino, J. and Polens, R.E. (2010). Ethnic differences in antidepressant response: a prospective multi-site clinical trial. Depression and Anxiety 27(1), 56-62.

. Schraufnagel, T.J., Wagner, A.W., Miranda, J. and Roy-Byrne, P.P. (2006). Treating minority patients with depression and anxiety: what does the evidence tell us ? General Hospital Psychiatry 28(1), 27-36.

. Stahl, S.M. (2000). Placebo-controlled comparison of the selective serotonin re-uptake inhibitors citalopram and sertraline. Biological Psychiatry 48(9), 894-901.

. Bielski, R.J., Ventura, D. and Chang, C.C. (2004). A double-blind comparison of escitalopram and venlafaxine extended release in the treatment of major depressive dis-order. Clinical Psychiatry 65(9), 1190-1196.

. Shelton, R.C., Haman, K.L., Rapaport, M.H., Kiev, A., Smith, W.T., Hirschfeld, R.M., Lydiard, R.B., Zajecka, J.M. and Dunner, D.L. (2006). A randomized, double-blind, active-control study of sertraline versus venlafaxine XR in major depressive disorder. Journal of Clinical Psy-chiatry 67(11), 1674-1681.

. Keller, M.B., Geleberg, A.J, Hirchfeld, R.M. et al. (1998). The treatment of chronic depression, part 2: a double-blind, randomized trial of sertraline and imipramine. Journal of Clinical Psychiatry 59(11), 598-607.

. Mollica, R.F. and Milic, M. (1986). Social class and psychiatric practice: a revision of the Hollingshead and Redlich model. American Journal of Psychiatry 143(1), 12-17.

. Blishen, B.R. (1967). Socio-economic Index for Oc-cupations in Canada. Canadian Review of Sociology and Anthropology 4(1), 41-53.

. Araya, R., Flynn, T., Rojas, G., Fritsch, R. and Simon, G. (2006). Cost-effectiveness of a primary care treatment program for depression in low-income women in Santiago, Chile. American Journal of Psychiatry 163(8), 1379-1387.

. Miranda, J. and Cooper, L.A. (2004). Disparities in care for depression among primary care patients. Journal of General and Internal Medicine 19(2), 120-126.

. Roy-Byrne, P.P., Perera, P., Pitts, C.D. and Christi, J.A. (2005). Paroxetine response and tolerability among ethnic minority patients with mood or anxiety disorders: a pooled analysis. Journal of Clinical Psychiatry 66(10), 1228-1233.

. Blier, P., Ward, H.E., Tremblay, P., Laberge, L., Hebert, C. and Bergeron, R. (2010). Combination of anti-depressant medications from treatment initiation for major depressive disorder: a double-blind randomized study. American Journal of Psychiatry 167(3), 281-288.

. Cutler, A.J., Montgomery, S.A., Feifel, D., Lazarus, A., Astrom, M. and Brecher, M. (2009). Extended release quetiapine fumarate monotherapy in major depressive disorder: a placebo- and duloxetine-controlled study. Journal of Clinical Psychiatry 70(4), 526-539.

. Kasper, S., Hajak, G., Wulff, K., Hoogendijk, W.L. et al. (2010). Efficacy of the novel antidepressant agome-latine on the circadian rest-activity cycle and depressive and anxiety symptoms in patients with major depressive disorder: a randomized, double-blind comparison with sertraline. Journal of Clinical Psychiatry 71(2), 109-120.

. Liebowitz, M.R., Yeung, P.P. and Entsuah, R. (2007). A randomized, double-blind, placebo-controlled trial of desvenlafaxine succinate in adult out-patients with major depressive disorder. Journal of Clinical Psychiatry 68(11), 1663-1672.

. Perahia, D.G., Quail, D., Desaiah, D., Corruble, E. and Fava, M. (2008). Switching to duloxetine from selective serotonin re-uptake inhibitor antidepressants: a multi-centre trial comparing 2 switching techniques. Journal of Clinical Psychiatry 69(1), 95-105.

. Stahl, S.M., Fava, M., Trivedi, M.H., Caputo, A., Shah, A. and Post, A. (2010). Agomelatine in the treat-ment of major depressive disorder: an 8-week, multicenter, randomized, placebo-controlled trial. Journal of Clinical Psychiatry 71(5), 616-626.

. Whitmyer, V.G., Dunner, D.L., Kornstein, S.G., Meyers, A.L., Mallinckrodt, C.H., Wohlreich, M.M. et al. (2007). A comparison of initial duloxetine dosing strategies in patients with major depressive disorder. Journal of Clinical Psychiatry 68(12), 1921-1930.