Skip to main content
×
Home
    • Aa
    • Aa
  • Get access
    Check if you have access via personal or institutional login
  • Cited by 26
  • Cited by
    This article has been cited by the following publications. This list is generated based on data provided by CrossRef.

    Mewton, Louise and Andrews, Gavin 2015. Cognitive behaviour therapy via the internet for depression: A useful strategy to reduce suicidal ideation. Journal of Affective Disorders, Vol. 170, p. 78.


    Moon, Eunsoo Sakong, Jeong Kyu Jung, Sung Won Sung, Hyung Mo Lee, Jun Yeop Koo, Bon Hoon Kim, Yang Tae Shin, Im Hee Cho, Hyunju Kim, Dae Hyun Kim, Min Kyung Choi, Jung Sik Jung, In Myung and Kim, Jung Bum 2014. Development of Clinical Guideline for the Diagnosis and Evaluation of Depression: Focused on Evaluation Guideline. Journal of Korean Neuropsychiatric Association, Vol. 53, Issue. 1, p. 24.


    Schat, A. van Noorden, M.S. Noom, M.J. Giltay, E.J. van der Wee, N.J.A. Vermeiren, R.R.J.M. and Zitman, F.G. 2013. Predictors of outcome in outpatients with anxiety disorders: The Leiden routine outcome monitoring study. Journal of Psychiatric Research, Vol. 47, Issue. 12, p. 1876.


    Peeters, Frenk Huibers, Marcus Roelofs, Jeffrey van Breukelen, Gerard Hollon, Steven D. Markowitz, John C. van Os, Jim and Arntz, Arnoud 2013. The clinical effectiveness of evidence-based interventions for depression: A pragmatic trial in routine practice. Journal of Affective Disorders, Vol. 145, Issue. 3, p. 349.


    Kennedy-Martin, Tessa Curtis, Sarah Faries, Douglas Robinson, Susan and Johnston, Joseph 2015. A literature review on the representativeness of randomized controlled trial samples and implications for the external validity of trial results. Trials, Vol. 16, Issue. 1,


    van Noorden, Martijn S. van Fenema, Esther M. van der Wee, Nic J. A. Zitman, Frans G. and Giltay, Erik J. 2012. PREDICTING OUTCOME OF DEPRESSION USING THE DEPRESSIVE SYMPTOM PROFILE: THE LEIDEN ROUTINE OUTCOME MONITORING STUDY. Depression and Anxiety, Vol. 29, Issue. 6, p. 523.


    van der Lem, Rosalind van der Wee, Nic J.A. van Veen, Tineke and Zitman, Frans G. 2012. Efficacy versus Effectiveness: A Direct Comparison of the Outcome of Treatment for Mild to Moderate Depression in Randomized Controlled Trials and Daily Practice. Psychotherapy and Psychosomatics, Vol. 81, Issue. 4, p. 226.


    Zimmerman, Mark Clark, Heather L. Multach, Matthew D. Walsh, Emily Rosenstein, Lia K. and Gazarian, Douglas 2015. Have Treatment Studies of Depression Become Even Less Generalizable? A Review of the Inclusion and Exclusion Criteria Used in Placebo-Controlled Antidepressant Efficacy Trials Published During the Past 20 Years. Mayo Clinic Proceedings, Vol. 90, Issue. 9, p. 1180.


    Zimmerman, Mark Clark, Heather L. Multach, Matthew D. Walsh, Emily Rosenstein, Lia K. and Gazarian, Douglas 2016. Inclusion/exclusion criteria in placebo-controlled studies of vortioxetine: Comparison to other antidepressants and implications for product labeling. Journal of Affective Disorders, Vol. 190, p. 357.


    Zimmerman, Mark Clark, Heather L. Multach, Matthew D. Walsh, Emily Rosenstein, Lia K. and Gazarian, Douglas 2016. Variability in the substance use disorder exclusion criterion in antidepressant efficacy trials. Journal of Affective Disorders, Vol. 198, p. 39.


    Zimmerman, Mark Holst, Carolina Guzman Clark, Heather L. Multach, Matthew Walsh, Emily Rosenstein, Lia K. and Gazarian, Douglas 2016. The Psychiatric Inclusion and Exclusion Criteria in Placebo-Controlled Monotherapy Trials of Bipolar Depression: An Analysis of Studies of the Past 20 Years. CNS Drugs,


    Zimmerman, Mark Multach, Matthew D. Clark, Heather L. Walsh, Emily Rosenstein, Lia K. and Gazarian, Douglas 2016. Inclusion/exclusion criteria in late life depression antidepressant efficacy trials. International Journal of Geriatric Psychiatry,


    Zimmerman, Mark Martinez, Jennifer H. Friedman, Michael Boerescu, Daniela A. Attiullah, Naureen and Toba, Cristina 2013. Determining severity subtypes of depression with a self-report questionnaire. Psychiatry Research, Vol. 206, Issue. 1, p. 98.


    Zimmerman, Mark Multach, Matthew Walsh, Emily Rosenstein, Lia K. Gazarian, Douglas and Clark, Heather L. 2016. Problems in the Descriptions of the Psychiatric Inclusion and Exclusion Criteria in Publications of Antidepressant Efficacy Trials: A Qualitative Review and Recommendations for Improved Clarity. CNS Drugs, Vol. 30, Issue. 3, p. 185.


    van der Lem, Rosalind de Wever, Wouter WH van der Wee, Nic JA van Veen, Tineke Cuijpers, Pim and Zitman, Frans G 2012. The generalizability of psychotherapy efficacy trials in major depressive disorder: an analysis of the influence of patient selection in efficacy trials on symptom outcome in daily practice. BMC Psychiatry, Vol. 12, Issue. 1,


    Bet, Pierre M. Hugtenburg, Jacqueline G. Penninx, Brenda W.J.H. and Hoogendijk, Witte J.G. 2013. Side effects of antidepressants during long-term use in a naturalistic setting. European Neuropsychopharmacology, Vol. 23, Issue. 11, p. 1443.


    Gao, Keming Wang, Zuowei Chen, Jun Kemp, David E. Chan, Philip K. Conroy, Carla M. Serrano, Mary Beth Ganocy, Stephen J. and Calabrese, Joseph R. 2013. Should an assessment of Axis I comorbidity be included in the initial diagnostic assessment of mood disorders? Role of QIDS-16-SR total score in predicting number of Axis I comorbidity. Journal of Affective Disorders, Vol. 148, Issue. 2-3, p. 256.


    van der Lem, R. Stamsnieder, P. M. van der Wee, N. J. A. van Veen, T. and Zitman, F. G. 2013. Influence of sociodemographic and socioeconomic features on treatment outcome in RCTs versus daily psychiatric practice. Social Psychiatry and Psychiatric Epidemiology, Vol. 48, Issue. 6, p. 975.


    Ulbricht, Christine M. Rothschild, Anthony J. and Lapane, Kate L. 2015. The association between latent depression subtypes and remission after treatment with citalopram: A latent class analysis with distal outcome. Journal of Affective Disorders, Vol. 188, p. 270.


    Carlier, Ingrid V.E. Colijn, Sjoerd van Rood, Yanda R. Streevelaar, Marion F. van Vliet, Irene M. and van Veen, Tineke 2014. A comparative analysis of personality pathology profiles among patients with pure depressive-, pure anxiety-, and pure somatoform disorders. Journal of Affective Disorders, Vol. 168, p. 322.


    ×

The generalizability of antidepressant efficacy trials to routine psychiatric out-patient practice

  • R. van der Lem (a1), N. J. A. van der Wee (a1) (a2), T. van Veen (a1) and F. G. Zitman (a1)
  • DOI: http://dx.doi.org/10.1017/S0033291710002175
  • Published online: 16 November 2010
Abstract
Background

Generalizability of antidepressant efficacy trials (AETs) to daily practice is questioned because of their very stringent patient selection. This study aims to determine eligibility for AETs of out-patients suffering from major depression in a routine out-patient setting and investigates influence of eligibility on treatment outcome.

Method

Data collection (n=1653) was performed through routine outcome monitoring by independent trained research nurses. The Mini-International Neuropsychiatric Interview Plus and the Dimensional Assessment of Personality Pathology, short Dutch version were used for diagnostic assessment and personality pathology screening. The Montgomery–Asberg Depression Rating Scale (MADRS) was used for assessment of baseline severity and treatment outcome. Eligibility was assessed by stepwise application of commonly used exclusion criteria. Influence of eligibility on treatment outcome was investigated in a subsample of the 1653 patients who had at least one follow-up assessment (n=626). Eligible and non-eligible patients were compared on proportion of response (50% reduction) and remission on MADRS (MADRS⩽10).

Results

Altogether, 17–25% of the patients were eligible for AETs. The most common reasons for exclusion would be ‘not meeting minimum baseline severity’ and ‘presence of co-morbid Axis I disorder’. Eligible and non-eligible patients did not differ in treatment outcome. Only ‘meeting the minimum baseline severity’ is associated with remission.

Conclusions

The majority of ‘real life’ out-patients are not eligible for AETs. However, the influence of eligibility on treatment outcome seems to be small. This suggests that stringent patient selection by eligibility criteria is not the major reason for lack of generalizability of AETs. Exclusion of less severely depressed patients from the analyses resulted in better treatment outcome. Milder depression is highly prevalent in daily practice and more research into treatment effectiveness in milder depression is warranted.

Copyright
Corresponding author
*Address for correspondence: Drs. R. van der Lem, LUMC, Department of Psychiatry, Albinusdreef 2, PO box 9600, 2300 RC Leiden, The Netherlands. (Email: r.van_der_lem@lumc.nl)
Linked references
Hide All

This list contains references from the content that can be linked to their source. For a full set of references and notes please see the PDF or HTML where available.

M Asberg , SA Montgomery , C Perris , D Schalling , G Sedvall (1978). A comprehensive psychopathological rating scale. Acta Psychiatrica Scandinavica (Suppl.), 5–27.

O Benkert , A Szegedi , M Philipp , R Kohnen , C Heinrich , A Heukels , M van der Vegte-Senden , RA Baker , JH Simmons , AJ Schutte (2006). Mirtazapine orally disintegrating tablets versus venlafaxine extended release: a double-blind, randomized multicenter trial comparing the onset of antidepressant response in patients with major depressive disorder. Journal of Clinical Psychopharmacology 26, 7578.

RJ Bielski , D Ventura , CC Chang (2004). A double-blind comparison of escitalopram and venlafaxine extended release in the treatment of major depressive disorder. Journal of Clinical Psychiatry 65, 11901196.

TJ Carmody , AJ Rush , I Bernstein , D Warden , S Brannan , D Burnham , A Woo , MH Trivedi (2006). The Montgomery Asberg and the Hamilton ratings of depression: a comparison of measures. European Neuropsychopharmacology 16, 601611.

E de Beurs , T Rinne , D van Kampen , R Verheul , H Andrea (2009). Reliability and validity of the Dutch Dimensional Assessment of Personality Pathology-Short Form (DAPP-SF), a shortened version of the DAPP-Basic Questionnaire. Journal of Personality Disorders 23, 308326.

RJ Derubeis , SD Hollon , JD Amsterdam , RC Shelton , PR Young , RM Salomon , JP O'Reardon , ML Lovett , MM Gladis , LL Brown , R Gallop (2005). Cognitive therapy vs medications in the treatment of moderate to severe depression. Archives of General Psychiatry 62, 409416.

MJ Detke , Y Lu , DJ Goldstein , JR Hayes , MA Demitrack (2002). Duloxetine, 60 mg once daily, for major depressive disorder: a randomized double-blind placebo-controlled trial. Journal of Clinical Psychiatry 63, 308315.

AR Donders , GJ van der Heijden , T Stijnen , KG Moons (2006). Review: a gentle introduction to imputation of missing values. Journal of Clinical Epidemiology 59, 10871091.

LF Fabre , FS Abuzzahab , M Amin , JL Claghorn , J Mendels , WM Petrie , S Dube , JG Small (1995). Sertraline safety and efficacy in major depression: a double-blind fixed-dose comparison with placebo. Biological Psychiatry 38, 592602.

GA Fava , C Ruini , C Rafanelli (2005). Sequential treatment of mood and anxiety disorders. Journal of Clinical Psychiatry 66, 13921400.

RN Golden , CB Nemeroff , P McSorley , CD Pitts , EM Dube (2002). Efficacy and tolerability of controlled-release and immediate-release paroxetine in the treatment of depression. Journal of Clinical Psychiatry 63, 577584.

DJ Goldstein , Y Lu , MJ Detke , C Wiltse , C Mallinckrodt , MA Demitrack (2004). Duloxetine in the treatment of depression: a double-blind placebo-controlled comparison with paroxetine. Journal of Clinical Psychopharmacology 24, 389399.

DJ Goldstein , C Mallinckrodt , Y Lu , MA Demitrack (2002). Duloxetine in the treatment of major depressive disorder: a double-blind clinical trial. Journal of Clinical Psychiatry 63, 225231.

M Hamilton (1967). Development of a rating scale for primary depressive illness. British Journal of Social and Clinical Psychology 6, 278296.

S Hatcher (2008). The STAR*D trial: the 300 lb gorilla is in the room, but does it block all the light? Evidence Based Mental Health 11, 9799.

CJ Hawley , TM Gale , VRH Smith , P Sen (1998). Depression rating scales can be related to each other by simple equations. International Journal of Psychiatry in Clinical Practice 2, 215219.

MA IJff , KM Huijbregts , HW van Marwijk , AT Beekman , L Hakkaart-van Roijen , FF Rutten , J Unutzer , CM van der Feltz-Cornelis (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. British Medical Care, Health Service Research 7, 34.

S Langworth , O Bodlund , H Agren (2006). Efficacy and tolerability of reboxetine compared with citalopram: a double-blind study in patients with major depressive disorder. Journal of Clinical Psychopharmacology 26, 121127.

IM Lesser , AF Leuchter , MH Trivedi , LL Davis , SR Wisniewski , GK Balasubramani , T Petersen , D Stegman , AJ Rush (2005). Characteristics of insured and noninsured outpatients with depression in STAR(*)D. Psychiatric Services 56, 995–1004.

RW Licht , G Gouliaev , P Vestergaard , M Frydenberg (1997). Generalisability of results from randomised drug trials. A trial on antimanic treatment. British Journal of Psychiatry 170, 264267.

RT Mulder , C Frampton , PR Joyce , R Porter (2003). Randomized controlled trials in psychiatry. Part II: their relationship to clinical practice. Australian and New Zealand Journal of Psychiatry 37, 265269.

RT Mulder , PR Joyce , CM Frampton , SE Luty , PF Sullivan (2006). Six months of treatment for depression: outcome and predictors of the course of illness. American Journal of Psychiatry 163, 95–100.

T Partonen , S Sihvo , JK Lonnqvist (1996). Patients excluded from an antidepressant efficacy trial. Journal of Clinical Psychiatry 57, 572575.

MA Posternak , M Zimmerman , GI Keitner , IW Miller (2002). A re-evaluation of the exclusion criteria used in antidepressant efficacy trials. American Journal of Psychiatry 159, 191200.

AJ Rush , M Fava , SR Wisniewski , PW Lavori , MH Trivedi , HA Sackeim , ME Thase , AA Nierenberg , FM Quitkin , TM Kashner , DJ Kupfer , JF Rosenbaum , J Alpert , JW Stewart , PJ McGrath , MM Biggs , K Shores-Wilson , BD Lebowitz , L Ritz , G Niederehe (2004). Sequenced treatment alternatives to relieve depression (STAR*D): rationale and design. Controlled Clinical Trials 25, 119142.

RC Shelton , KL Haman , MH Rapaport , A Kiev , WT Smith , RM Hirschfeld , RB Lydiard , JM Zajecka , DL Dunner (2006). A randomized, double-blind, active-control study of sertraline versus venlafaxine XR in major depressive disorder. Journal of Clinical Psychiatry 67, 16741681.

A Sir , RF D'Souza , S Uguz , T George , S Vahip , M Hopwood , AJ Martin , W Lam , T Burt (2005). Randomized trial of sertraline versus venlafaxine XR in major depression: efficacy and discontinuation symptoms. Journal of Clinical Psychiatry 66, 13121320.

SM Stahl (2000). Placebo-controlled comparison of the selective serotonin reuptake inhibitors citalopram and sertraline. Biological Psychiatry 48, 894901.

MH Trivedi , TA Pigotti , P Perera , KE Dillingham , ML Carfagno , CD Pitts (2004). Effectiveness of low doses of paroxetine controlled release in the treatment of major depressive disorder. Journal of Clinical Psychiatry 65, 13561364.

R Uher , W Maier , J Hauser , A Marusic , C Schmael , O Mors , N Henigsberg , D Souery , A Placentino , M Rietschel , A Zobel , M Dmitrzak-Weglarz , A Petrovic , L Jorgensen , P Kalember , C Giovannini , M Barreto , A Elkin , S Landau , A Farmer , KJ Aitchison , P McGuffin (2009). Differential efficacy of escitalopram and nortriptyline on dimensional measures of depression. British Journal of Psychiatry 194, 252259.

D van Kampen , E de Beurs , H Andrea (2008). A short form of the Dimensional Assessment of Personality Pathology-Basic Questionnaire (DAPP-BQ): the DAPP-SF. Psychiatry Research 160, 115128.

KB Wells (1999). Treatment research at the crossroads: the scientific interface of clinical trials and effectiveness research. American Journal of Psychiatry 156, 5–10.

SR Wisniewski , AJ Rush , AA Nierenberg , BN Gaynes , D Warden , JF Luther , PJ McGrath , PW Lavori , ME Thase , M Fava , MH Trivedi (2009). Can phase III trial results of antidepressant medications be generalized to clinical practice? A STAR*D report. American Journal of Psychiatry 166, 599607.

M Zetin , CT Hoepner (2007). Relevance of exclusion criteria in antidepressant clinical trials: a replication study. Journal of Clinical Psychopharmacology 27, 295301.

M Zimmerman , I Chelminski , MA Posternak (2004 a). Exclusion criteria used in antidepressant efficacy trials: consistency across studies and representativeness of samples included. Journal of Nervous and Mental Disease 192, 8794.

M Zimmerman , JI Mattia , MA Posternak (2002 a). Are subjects in pharmacological treatment trials of depression representative of patients in routine clinical practice? American Journal of Psychiatry 159, 469473.

M Zimmerman , MA Posternak , I Chelminski (2002 b). Symptom severity and exclusion from antidepressant efficacy trials. Journal of Clinical Psychopharmacology 22, 610614.

M Zimmerman , MA Posternak , I Chelminski (2004 b). Derivation of a definition of remission on the Montgomery-Asberg depression rating scale corresponding to the definition of remission on the Hamilton rating scale for depression. Journal of Psychiatric Research 38, 577582.

Recommend this journal

Email your librarian or administrator to recommend adding this journal to your organisation's collection.

Psychological Medicine
  • ISSN: 0033-2917
  • EISSN: 1469-8978
  • URL: /core/journals/psychological-medicine
Please enter your name
Please enter a valid email address
Who would you like to send this to? *
×

Keywords:

Type Description Title
UNKNOWN
Supplementary Materials

Lem supplementary material
Appendix.doc

 Unknown (111 KB)
111 KB