0
Get Alert
Please Wait... Processing your request... Please Wait.
You must sign in to sign-up for alerts.

Please confirm that your email address is correct, so you can successfully receive this alert.

Articles   |    
Generalizability of Findings From Efficacy Trials for Chronic Depression: An Analysis of Eligibility Criteria
Alessa von Wolff, M.A.; Malte Jansen, M.A.; Lars P. Hölzel, Ph.D.; Annika Westphal, B.A.; Martin Härter, M.D., Ph.D.; Levente Kriston, Ph.D.
Psychiatric Services 2014; doi: 10.1176/appi.ps.201300309
View Author and Article Information

Ms. von Wolff, Ms. Westphal, Dr. Härter, and Dr. Kriston are with the Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany (e-mail: a.von-wolff@uke.de). Mr. Jansen is with the Institute for Educational Quality Improvement, Humboldt University Berlin, Germany. Dr. Hölzel is with the Department of Psychiatry and Psychotherapy, University Medical Center Freiburg, Freiburg, Germany.

Copyright © 2014 by the American Psychiatric Association

Abstract

Objectives  Concerns have been raised that the rigorous eligibility criteria used to select patients for randomized controlled trials (RCTs) limit the generalizability of trial findings. The objectives of this study were to identify commonly used eligibility criteria in RCTs for chronic depression, to examine whether these criteria are met by patients with chronic depression who are in routine care, and to identify differences between patients who would and would not meet RCT criteria.

Methods  Thirteen eligibility criteria were extracted from eight RCTs of combined psychotherapeutic and pharmacological interventions for patients with chronic depression. These criteria were then applied to a sample of patients with chronic depression receiving care in one of ten German hospitals (N=231). Demographic, clinical, and treatment characteristics of those who met the RCT criteria and those who did not were compared in univariate and multivariate analyses.

Results  Only 25% of the 231 inpatients met all RCT eligibility criteria. Patients were ineligible mainly because of suicide risk, low severity of depression at admission, and concurrent psychiatric or somatic disorders. No statistically significant differences were found between those who met the criteria and those who did not in demographic characteristics, length of inpatient stay, treatment outcome, and efficacy of certain antidepressants, except that slightly more patients meeting RCT criteria received selective serotonin reuptake inhibitors.

Conclusions  Findings suggest that the generalizability of RCT findings to routine health care is less limited than frequently supposed.

Abstract Teaser
Figures in this Article

Your Session has timed out. Please sign back in to continue.
Sign In Your Session has timed out. Please sign back in to continue.
Sign In to Access Full Content
 
Username
Password
Sign in via Athens (What is this?)
Athens is a service for single sign-on which enables access to all of an institution's subscriptions on- or off-site.
Not a subscriber?

Subscribe Now/Learn More

PsychiatryOnline subscription options offer access to the DSM-5 library, books, journals, CME, and patient resources. This all-in-one virtual library provides psychiatrists and mental health professionals with key resources for diagnosis, treatment, research, and professional development.

Need more help? PsychiatryOnline Customer Service may be reached by emailing PsychiatryOnline@psych.org or by calling 800-368-5777 (in the U.S.) or 703-907-7322 (outside the U.S.).

Anchor for Jump
Table 1Studies that examined differences between patients with depression who were eligible for a randomized controlled trial (RCT patients) and those who did not meet eligibility criteria (non-RCT patients)a
Table Footer Note

a Abbreviations: BDI, Beck Depression Inventory; HAM-D, Hamilton Rating Scale for Depression

Table Footer Note

b Depending on assessment of personality

Anchor for Jump
Table 2Eligibility criteria used in eight randomized controlled trials and patients in a routine care sample (N=231) who met or did not meet them
Table Footer Note

a Assessed in accordance with the AMDP (Working Group for Methodology and Documentation in Psychiatry) system by the physician at admission

Table Footer Note

b Not applicable; no corresponding data collected in routine care

Anchor for Jump
Table 3Characteristics of patients in a routine care sample (N=231) who met or did not meet all eligibility criteria for inclusion in randomized controlled trialsa
Table Footer Note

a Means were compared by t tests, and proportions were compared by chi square tests (Fisher’s exact test).

Table Footer Note

b Hamilton Rating Scale for Depression. Possible scores range from 0 to 66, with higher scores indicating greater depression severity.

Table Footer Note

c Schizophrenia, other psychotic disorder, bipolar disorder, or substance use disorder

Table Footer Note

d Venlafaxine, mirtazapine, and reboxetine

Anchor for Jump
Table 4Treatment response of patients in routine care (N=231) who met all eligibility criteria for inclusion in randomized controlled trials (RCT patients) and those who did not (non-RCT patients)a
Table Footer Note

a Reference group, psychotherapy. To compare odds ratios (ORs) of response rates, multigroup logistic regression models were estimated. The differences in regression coefficients were tested for significance (difference from zero) by z tests.

Table Footer Note

b Venlafaxine, mirtazapine, and reboxetine

+

References

Satyanarayana  S;  Enns  MW;  Cox  BJ  et al:  Prevalence and correlates of chronic depression in the Canadian community health survey: mental health and well-being.  Canadian Journal of Psychiatry 54:389–398, 2009
 
Berndt  ER;  Koran  LM;  Finkelstein  SN  et al:  Lost human capital from early-onset chronic depression.  American Journal of Psychiatry 157:940–947, 2000
[CrossRef] | [PubMed]
 
Gilmer  WS;  Trivedi  MH;  Rush  AJ  et al:  Factors associated with chronic depressive episodes: a preliminary report from the STAR-D project.  Acta Psychiatrica Scandinavica 112:425–433, 2005
[CrossRef] | [PubMed]
 
Browne  G;  Steiner  M;  Roberts  J  et al:  Sertraline and/or interpersonal psychotherapy for patients with dysthymic disorder in primary care: 6-month comparison with longitudinal 2-year follow-up of effectiveness and costs.  Journal of Affective Disorders 68:317–330, 2002
[CrossRef] | [PubMed]
 
de Mello  MF;  Myczcowisk  LM;  Menezes  PR:  A randomized controlled trial comparing moclobemide and moclobemide plus interpersonal psychotherapy in the treatment of dysthymic disorder.  Journal of Psychotherapy Practice and Research 10:117–123, 2001
[PubMed]
 
Keller  MB;  McCullough  JP;  Klein  DN  et al:  A comparison of nefazodone, the cognitive behavioral-analysis system of psychotherapy, and their combination for the treatment of chronic depression.  New England Journal of Medicine 342:1462–1470, 2000
[CrossRef] | [PubMed]
 
Kocsis  JH;  Gelenberg  AJ;  Rothbaum  BO  et al; REVAMP Investigators:  Cognitive behavioral analysis system of psychotherapy and brief supportive psychotherapy for augmentation of antidepressant nonresponse in chronic depression: the REVAMP Trial.  Archives of General Psychiatry 66:1178–1188, 2009
[CrossRef] | [PubMed]
 
Markowitz  JC;  Kocsis  JH;  Bleiberg  KL  et al:  A comparative trial of psychotherapy and pharmacotherapy for “pure” dysthymic patients.  Journal of Affective Disorders 89:167–175, 2005
[CrossRef] | [PubMed]
 
Miller  IW;  Norman  WH;  Keitner  GI:  Combined treatment for patients with double depression.  Psychotherapy and Psychosomatics 68:180–185, 1999
[CrossRef] | [PubMed]
 
Ravindran  AV;  Anisman  H;  Merali  Z  et al:  Treatment of primary dysthymia with group cognitive therapy and pharmacotherapy: clinical symptoms and functional impairments.  American Journal of Psychiatry 156:1608–1617, 1999
[PubMed]
 
Schramm  E;  Schneider  D;  Zobel  I  et al:  Efficacy of interpersonal psychotherapy plus pharmacotherapy in chronically depressed inpatients.  Journal of Affective Disorders 109:65–73, 2008
[CrossRef] | [PubMed]
 
Rothwell  PM:  External validity of randomised controlled trials: “to whom do the results of this trial apply?” Lancet 365:82–93, 2005
[CrossRef] | [PubMed]
 
Green  LW;  Glasgow  RE:  Evaluating the relevance, generalization, and applicability of research: issues in external validation and translation methodology.  Evaluation and the Health Professions 29:126–153, 2006
[CrossRef] | [PubMed]
 
Tunis  SR;  Stryer  DB;  Clancy  CM:  Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy.  JAMA 290:1624-1632, 2003
[CrossRef] | [PubMed]
 
Stirman  SW;  DeRubeis  RJ;  Crits-Christoph  P  et al:  Are samples in randomized controlled trials of psychotherapy representative of community outpatients? A new methodology and initial findings.  Journal of Consulting and Clinical Psychology 71:963–972, 2003
[CrossRef] | [PubMed]
 
Zimmerman  M;  Mattia  JI;  Posternak  MA:  Are subjects in pharmacological treatment trials of depression representative of patients in routine clinical practice? American Journal of Psychiatry 159:469–473, 2002
[CrossRef] | [PubMed]
 
Parker  G:  Antidepressants on trial: how valid is the evidence? British Journal of Psychiatry 194:1–3, 2009
[CrossRef] | [PubMed]
 
Zimmerman  M;  Chelminski  I;  Posternak  MA:  Generalizability of antidepressant efficacy trials: differences between depressed psychiatric outpatients who would or would not qualify for an efficacy trial.  American Journal of Psychiatry 162:1370–1372, 2005
[CrossRef] | [PubMed]
 
van der Lem  R;  van der Wee  NJA;  van Veen  T  et al:  The generalizability of antidepressant efficacy trials to routine psychiatric out-patient practice.  Psychological Medicine 41:1353–1363, 2011
[CrossRef] | [PubMed]
 
Wisniewski  SR;  Rush  AJ;  Nierenberg  AA  et al:  Can phase III trial results of antidepressant medications be generalized to clinical practice? A STAR*D report.  American Journal of Psychiatry 166:599–607, 2009
[CrossRef] | [PubMed]
 
Zetin  M;  Hoepner  CT:  Relevance of exclusion criteria in antidepressant clinical trials: a replication study.  Journal of Clinical Psychopharmacology 27:295–301, 2007
[CrossRef] | [PubMed]
 
Schindler  AC;  Hiller  W;  Witthöft  M:  Benchmarking of cognitive-behavioral therapy for depression in efficacy and effectiveness studies: how do exclusion criteria affect treatment outcome? Psychotherapy Research 21:644–657, 2011
[CrossRef] | [PubMed]
 
van der Lem  R;  de Wever  WWH;  van der Wee  NJA  et al:  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 12:192, 2012
[CrossRef] | [PubMed]
 
Hölzel  LP;  Härter  M;  Reese  C  et al:  Risk factors for chronic depression: a systematic review.  Journal of Affective Disorders 129:1–13, 2011
[CrossRef] | [PubMed]
 
 Practice guideline for the treatment of patients with major depressive disorder.  American Journal of Psychiatry 167(suppl 10):1–152, 2010
[CrossRef] | [PubMed]
 
Depression: The Treatment and Management of Depression in Adults. National Clinical Practice Guideline 90. London, National Institute for Health and Clinical Excellence, 2009
 
Härter  M;  Klesse  C;  Bermejo  I  et al:  Evidence-based therapy of depression: S3 guidelines on unipolar depression [in German].  Der Nervenarzt 81:1049–1068, 2010
[CrossRef] | [PubMed]
 
Fritze  J:  Prescriptions for psychotropic drugs: results and comments on the 2007 prescription drug report [in German].  Der Nervenarzt 79:1337–1345, 2008
[CrossRef] | [PubMed]
 
Kriston  L;  von Wolff  A;  Hölzel  LP:  Effectiveness of psychotherapeutic, pharmacological, and combined treatments for chronic depression: a systematic review (METACHRON).  BMC Psychiatry 10:95, 2010
[CrossRef] | [PubMed]
 
von Wolff  A;  Hölzel  LP;  Westphal  A  et al:  Selective serotonin reuptake inhibitors and tricyclic antidepressants in the acute treatment of chronic depression and dysthymia: a systematic review and meta-analysis.  Journal of Affective Disorders 144:7–15, 2013
[CrossRef] | [PubMed]
 
von Wolff  A;  Hölzel  LP;  Westphal  A  et al:  Combination of pharmacotherapy and psychotherapy in the treatment of chronic depression: a systematic review and meta-analysis.  BMC Psychiatry , 2012; doi 10.1186/1471-244X-12-61
 
Schneider  F;  Härter  M;  Brand  S  et al:  Adherence to guidelines for treatment of depression in in-patients.  British Journal of Psychiatry 187:462–469, 2005
[CrossRef] | [PubMed]
 
Cording  C;  Gaebel  W;  Spengler  A  et al:  The new psychiatric basic documentation: a recommendation of the DGPPN for quality insurance in inpatient treatment [in German].  Spektrum der Psychiatrie und Nervenheilkunde 24:3–41, 1995
 
Hamilton  M:  A rating scale for depression.  Journal of Neurology, Neurosurgery, and Psychiatry 23:56–62, 1960
[CrossRef] | [PubMed]
 
Muthén  LK;  Muthén  BO:  Mplus, Version 6.1 .  Los Angeles,  Muthén and Muthén, 2011
 
Craig  P;  Dieppe  P;  Macintyre  S  et al  Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ, 2008; doi 10.1136/bmj.a1655
 
References Container
+
+

CME Activity

There is currently no quiz available for this resource. Please click here to go to the CME page to find another.
Submit a Comments
Please read the other comments before you post yours. Contributors must reveal any conflict of interest.
Comments are moderated and will appear on the site at the discertion of APA editorial staff.

* = Required Field
(if multiple authors, separate names by comma)
Example: John Doe



Related Content
Articles
Books
The American Psychiatric Publishing Textbook of Psychopharmacology, 4th Edition > Chapter 53.  >
APA Practice Guidelines > Chapter 0.  >
The American Psychiatric Publishing Textbook of Geriatric Psychiatry, 4th Edition > Chapter 29.  >
Manual of Clinical Psychopharmacology, 7th Edition > Chapter 1.  >
Gabbard's Treatments of Psychiatric Disorders, 4th Edition > Chapter 24.  >
Topic Collections
Psychiatric News
APA Guidelines
PubMed Articles