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

Psychological Medicine

Volumn 41, Issue 7, 2011, Pages 1353-1363

  Van Der Lem, R ^a   Van Der Wee, N J A ^a,b   Van Veen, T ^a   Zitman, F G ^a  

^a LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

^b LEIDEN UNIVERSITY   (Netherlands)

Author keywords

Antidepressant efficacy trials; eligibility generalizability; major depression; routine outcome monitoring

Indexed keywords

ANTIDEPRESSANT AGENT;

ADULT; AMBULATORY CARE; ARTICLE; CLINICAL PRACTICE; CLINICAL TRIAL (TOPIC); FEMALE; HUMAN; MAJOR DEPRESSION; MALE; METHODOLOGY; NETHERLANDS; OUTPATIENT; PATIENT SELECTION; PSYCHOLOGICAL ASPECT; PSYCHOLOGICAL RATING SCALE; STATISTICS; TREATMENT OUTCOME;

ADULT; AMBULATORY CARE; ANTIDEPRESSIVE AGENTS; CLINICAL TRIALS AS TOPIC; DEPRESSIVE DISORDER, MAJOR; FEMALE; HUMANS; MALE; NETHERLANDS; OUTPATIENTS; PATIENT SELECTION; PHYSICIAN'S PRACTICE PATTERNS; PSYCHIATRIC STATUS RATING SCALES; RESEARCH DESIGN; TREATMENT OUTCOME;

EID: 79958796188     PISSN: 00332917     EISSN: 14698978     Source Type: Journal    
DOI: 10.1017/S0033291710002175     Document Type: Article

References (51)

1. Anderson I, Pilling S, Barnes A, Bayliss L, Bird V (2009). The NICF guideline on the treatment and management of depression in adults. National Collaborating Centre for Mental Health and National Institute for Health and Clinical Excellence: The British Psychological Society and The Royal College of Psychiatrists.
2. Asberg M, Montgomery SA, Perris C, Schalling D, Sedvall G (1978). A comprehensive psychopathological rating scale. Acta Psychiatrica Scandinavica (Suppl.), 5-27. (Pubitemid 8341005)
3. Benkert O, Szegedi A, Philipp M, Kohnen R, Heinrich C, Heukels A, van der Vegte-Senden M, Baker RA, Simmons JH, Schutte AJ (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, 75-78. (Pubitemid 43167095)
4. Bielski RJ, Ventura D, Chang CC (2004). A double-blind comparison of escitalopram and venlafaxine extended release in the treatment of major depressive disorder. Journal ofClinical Psychiatry 65,1190-1196.
5. Carmody TJ, Rush AJ, Bernstein I, Warden D, Brannan S, Burnham D, Woo A, Trivedi MH (2006). The Montgomery Asberg and the Hamilton ratings of depression: a comparison of measures. European Neuropsychopharmacology 16, 601-611. (Pubitemid 44716667)
6. de Beurs E, den Hollander-Gijsman ME, van Rood YR, van der Wee NJ, Giltay EJ, van Noorden MS, van der Lem R, van Fenema E, Zitman FG (2010). Routine outcome monitoring in the Netherlands: practical experiences with a web-based strategy for the assessment of treatment outcome in clinical practice. Clinical Psychology & Psychotherapy. Published online: 17 March 2010. doi:10.1002/cpp.696.
7. de Beurs E, Rinne T, van Kampen D, Verheul R, Andrea H (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, 308-326.
8. DeMartinis NA, Schweizer E, Rickels K (1996). An open-label trial of nefazodone in high comorbidity panic disorder. Journal of Clinical Psychiatry 57, 245-248. (Pubitemid 26230647)
9. Derubeis RJ, Hollon SD, Amsterdam JD, Shelton RC, Young PR, Salomon RM, O'Reardon JP, Lovett ML, Gladis MM, Brown LL, Gallop R (2005). Cognitive therapy vs medications in the treatment of moderate to severe depression. Archives of General Psychiatry 62, 409-416. (Pubitemid 40471690)
10. Detke MJ, Lu Y, Goldstein DJ, Hayes JR, Demitrack MA (2002). Duloxetine, 60 mg once daily, for major depressive disorder: a randomized double-blind placebo-controlled trial. Journal of Clinical Psychiatry 63, 308-315. (Pubitemid 34456358)
11. Dinan TG (2001). Efficacy and safety of weekly treatment with enteric-coated fluoxetine in patients with major depressive disorder. Journal of Clinical Psychiatry 62 (Suppl. 22), 48-52. (Pubitemid 32937587)
12. Donders AR, van der Heijden GJ, Stijnen T, Moons KG (2006). Review: a gentle introduction to imputation of missing values. Journal of Clinical Epidemiology 59, 1087-1091. (Pubitemid 44374314)
13. Fabre LF, Abuzzahab FS, Amin M, Claghorn JL, Mendels J, Petrie WM, Dube S, Small JG (1995). Sertraline safety and efficacy in major depression: a double-blind fixed-dose comparison with placebo. Biological Psychiatry 38,592-602.
14. Fava GA, Ruini C, Rafanelli C (2005). Sequential treatment of mood and anxiety disorders. Journal of Clinical Psychiatry 66, 1392-1400. (Pubitemid 41779537)
15. Golden RN, Nemeroff CB, McSorley P, Pitts CD, Dube EM (2002). Efficacy and tolerability of controlled-release and immediate-release paroxetine in the treatment of depression. Journal of Clinical Psychiatry 63, 577-584. (Pubitemid 34787322)
16. Goldstein DJ, Lu Y, Detke MJ, Wiltse C, Mallinckrodt C, Demitrack MA (2004). Duloxetine in the treatment of depression: a double-blind placebo-controlled comparison with paroxetine. Journal of Clinical Psychopharmacology 24, 389-399. (Pubitemid 38944137)
17. Goldstein DJ, Mallinckrodt C, Lu Y, Demitrack MA (2002). Duloxetine in the treatment of major depressive disorder: a double-blind clinical trial. Journal of Clinical Psychiatry 63, 225-231. (Pubitemid 34407082)
18. Hamilton M (1967). Development of a rating scale for primary depressive illness. British Journal of Social and Clinical Psychology 6, 278-296.
19. Hatcher S (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, 97-99.
20. Hawley CJ, Gale TM, Smith VRH, Sen P (1998). Depression rating scales can be related to each other by simple equations. International Journal of Psychiatry in Clinical Practice 2,215-219. (Pubitemid 28462206)
21. IJff MA, Huijbregts KM, van Marwijk HW, Beekman AT, Hakkaart-van Roijen L, Rutten FF, Unutzer J, van der Feltz-Cornelis CM (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.
22. Karasu TB, Gelenberg A, Merriam A, Wang P (2000). Practice Guidelinefor the Treatment ofPatients with Major Depressive Disorder (2nd edn). Arlington, VA: American Psychiatric Association.
23. Langworth S, Bodlund O, Agren H (2006). Efficacy and tolerability of reboxetine compared with citalopram: a double-blind study in patients with major depressive disorder. Journal of Clinical Psychopharmacology 26,121-127. (Pubitemid 43740334)
24. Lesser IM, Leuchter AF, Trivedi MH, Davis LL, Wisniewski SR, Balasubramani GK, Petersen T, Stegman D, Rush AJ (2005). Characteristics of insured and noninsured outpatients with depression in STAR(*)D. Psychiatric Services 56,995-1004. (Pubitemid 41098740)
25. Licht RW, Gouliaev G, Vestergaard P, Frydenberg M (1997). Generalisability of results from randomised drug trials. A trial on antimanic treatment. British Journal of Psychiatry 170, 264-267. (Pubitemid 27117690)
26. Livesley WJ, Jackson DW, Schroeder ML (1991). Dimensions of personality pathology. Canadian Journal of Psychiatry 36,557-562.
27. Mittmann N, Mitter S, Borden EK, Herrmann N, Naranjo CA, Shear NH (1997). Montgomery-Asberg severity gradations. American Journal of Psychiatry 154, 1320-1321.
28. Mulder RT, Frampton C, Joyce PR, Porter R (2003). Randomized controlled trials in psychiatry. Part II: their relationship to clinical practice. Australian and New Zealand Journal of Psychiatry 37,265-269. (Pubitemid 36833755)
29. Mulder RT, Joyce PR, Frampton CM, Luty SE, Sullivan PF (2006). Six months of treatment for depression: outcome and predictors of the course of illness. American Journal of Psychiatry 163, 95-100. (Pubitemid 43050109)
30. National Taskforce Guideline Development in Mental Health Care (2005). Multidisciplinary guideline for diagnostics and treatment for adult patients suffering from depression, revised version. Utrecht: Trimbos Institute.
31. Partonen T, Sihvo S, Lonnqvist JK (1996). Patients excluded from an antidepressant efficacy trial. Journal of Clinical Psychiatry 57,572-575. (Pubitemid 27056898)
32. Posternak MA, Zimmerman M, Keitner GI, Miller IW (2002). A re-evaluation of the exclusion criteria used in antidepressant efficacy trials. American Journal of Psychiatry 159,191-200. (Pubitemid 34126894)
33. Royston P (2005). Multiple imputation of missing values: update. Stata Journal 5, 188-201. (Pubitemid 43708483)
34. Rush AJ, Fava M, Wisniewski SR, Lavori PW, Trivedi MH, Sackeim HA, Thase ME, Nierenberg AA, Quitkin FM, Kashner TM, Kupfer DJ, Rosenbaum JF, Alpert J, Stewart JW, McGrath PJ, Biggs MM, Shores-Wilson K, Lebowitz BD, Ritz L, Niederehe G (2004). Sequenced treatment alternatives to relieve depression (STAR*D): rationale and design. Controlled Clinical Trials 25, 119-142.
35. Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC (1998). The Mini-International Neuropsychiatric Interview (MINI): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. Journal ofClinical Psychiatry 59 (Suppl. 20), 22-33. (Pubitemid 29001829)
36. Shelton RC, Haman KL, Rapaport MH, Kiev A, Smith WT, Hirschfeld RM, Lydiard RB, Zajecka JM, Dunner DL (2006). A randomized, double-blind, active-control study of sertraline versus venlafaxine XR in major depressive disorder. Journal of Clinical Psychiatry 67, 1674-1681. (Pubitemid 44955146)
37. Sir A, D'Souza RF, Uguz S, George T, Vahip S, Hopwood M, Martin AJ, Lam W, Burt T (2005). Randomized trial of sertraline versus venlafaxine XR in major depression: efficacy and discontinuation symptoms. Journal of Clinical Psychiatry 66,1312-1320. (Pubitemid 41546512)
38. Stahl SM (2000). Placebo-controlled comparison of the selective serotonin reuptake inhibitors citalopram and sertraline. Biological Psychiatry 48, 894-901.
39. Stewart JW, McGrath PJ, Quitkin FM (1992). Can mildly depressed outpatients with atypical depression benefit from antidepressants? American Journal of Psychiatry 149, 615-619.
40. Trivedi MH, Pigotti TA, Perera P, Dillingham KE, Carfagno ML, Pitts CD (2004). Effectiveness of low doses of paroxetine controlled release in the treatment of major depressive disorder. Journal of Clinical Psychiatry 65, 1356-1364.
41. Tunis SR, Stryer DB, Clancy CM (2003). Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy. Journal of the American Medical Association 290,1624-1632. (Pubitemid 37430387)
42. Uher R, Farmer A, Maier W, Rietschel M, Hauser J, Marusic A, Mors O, Elkin A, Williamson RJ, Schmael C, Henigsberg N, Perez J, Mendlewicz J, Janzing JG, Zobel A, Skibinska M, Kozel D, Stamp AS, Bajs M, Placentino A, Barreto M, McGuffin P, Aitchison KJ (2008). Measuring depression: comparison and integration of three scales in the GENDEP study. Psychological Medicine 38, 289-300. (Pubitemid 351156595)
43. Uher R, Maier W, Hauser J, Marusic A, Schmael C, Mors O, Henigsberg N, Souery D, Placentino A, Rietschel M, Zobel A, Dmitrzak-Weglarz M, Petrovic A, Jorgensen L, Kalember P, Giovannini C, Barreto M, Elkin A, Landau S, Farmer A, Aitchison KJ, McGuffin P (2009). Differential efficacy of escitalopram and nortriptyline on dimensional measures of depression. BritishJournal of Psychiatry 194, 252-259.
44. Van Kampen D, de Beurs E, Andrea H (2008). A short form of the Dimensional Assessment of Personality Pathology-Basic Questionnaire (DAPP-BQ): the DAPP-SF. Psychiatry Research 160,115-128.
45. Wells KB (1999). Treatment research at the crossroads: the scientific interface of clinical trials and effectiveness research. American Journal of Psychiatry 156, 5-10. (Pubitemid 29034873)
46. Wisniewski SR, Rush AJ, Nierenberg AA, Gaynes BN, Warden D, Luther JF, McGrath PJ, Lavori PW, Thase ME, Fava M, Trivedi MH (2009). Can phase III trial results of antidepressant medications be generalized to clinical practice? A STAR*D report. American Journal of Psychiatry 166,599-607.
47. Zetin M, Hoepner CT (2007). Relevance of exclusion criteria in antidepressant clinical trials: a replication study. Journal of Clinical Psychopharmacology 27, 295-301. (Pubitemid 46763313)
48. Zimmerman M, Chelminski I, Posternak MA (2004a). Exclusion criteria used in antidepressant efficacy trials: consistency across studies and representativeness of samples included. Journal of Nervous and Mental Disease 192,87-94. (Pubitemid 38248899)
49. Zimmerman M, Mattia JI, Posternak MA (2002a). Are subjects in pharmacological treatment trials of depression representative of patients in routine clinical practice? American Journal of Psychiatry 159, 469-473. (Pubitemid 34184745)
50. Zimmerman M, Posternak MA, Chelminski I (2002b). Symptom severity and exclusion from antidepressant efficacy trials. Journal of Clinical Psychopharmacology 22, 610-614. (Pubitemid 35416787)
51. Zimmerman M, Posternak MA, Chelminski I (2004b). 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 38,577-582. (Pubitemid 39348889)