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Vol. 78, No. 3, 2009
Issue release date: April 2009
Section title: Regular Article
Psychother Psychosom 2009;78:172–181
(DOI:10.1159/000209348)

Does Study Design Influence Outcome?

The Effects of Placebo Control and Treatment Duration in Antidepressant Trials

Rutherford B.R. · Sneed J.R. · Roose S.P.
Department of Psychiatry, Columbia University and the New York State Psychiatric Institute, New York, N.Y., USA

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Article / Publication Details

First-Page Preview
Abstract of Regular Article

Received: 3/27/2008
Published online: 3/24/2009

Number of Print Pages: 10
Number of Figures: 1
Number of Tables: 4

ISSN: 0033-3190 (Print)
eISSN: 1423-0348 (Online)

For additional information: http://www.karger.com/PPS

Abstract

Background: Clinicians and researchers synthesize data from randomized controlled trials (RCTs) of antidepressants to make conclusions about the efficacy of medications for depression. All treatments include nonspecific factors in addition to the specific effects of drugs, and study design may influence patient outcomes via nonspecific factors. This study investigated whether placebo control and treatment duration affect the outcome in antidepressant RCTs. Methods: Medline and the Cochrane Database were searched to identify RCTs of antidepressants for major depression approved by the Food and Drug Administration. Included studies enrolled outpatient participants aged 18–65, lasted 6–12 weeks, compared an antidepressant to placebo or another antidepressant and were published in English after 1985. Excluded trials enrolled inpatients, pregnant women and subjects with psychosis or mania. Mixed-effects logistic regression models including study type (placebo-controlled or comparator) and study duration (6, 8 or 12 weeks) as fixed effects determined whether these factors affected response and remission rates. Results: In the 90 trials analyzed, the odds of depression response (OR = 1.79, 95% CI = 1.45–2.17, p < 0.001) and remission (OR 1.53, 95% CI = 1.11–2.11, p < 0.001) were significantly higher in comparator relative to placebo-controlled trials. Trials lasting 8 (OR = 1.37, CI = 1.14–1.64, p = 0.001) and 12 (OR = 1.52, CI = 1.12–2.07, p = 0.008) weeks had significantly greater response rates than 6-week trials without differing themselves. Conclusions: Response and remission rates to antidepressants are significantly affected by study type and duration. Clinicians and researchers must consider the study design when interpreting and designing RCTs of antidepressant medications.


  

Author Contacts

Bret R. Rutherford
1051 Riverside Drive, Box 98
New York, NY 10032 (USA)
Tel. +1 212 543 5746, Fax +1 212 543 6100
E-Mail brr8@columbia.edu

  

Article Information

Received: March 27, 2008
Published online: March 24, 2009
Number of Print Pages : 10
Number of Figures : 1, Number of Tables : 4, Number of References : 122

  

Publication Details

Psychotherapy and Psychosomatics

Vol. 78, No. 3, Year 2009 (Cover Date: April 2009)

Journal Editor: Fava G.A. (Bologna)
ISSN: 0033-3190 (Print), eISSN: 1423-0348 (Online)

For additional information: http://www.karger.com/PPS


Article / Publication Details

First-Page Preview
Abstract of Regular Article

Received: 3/27/2008
Published online: 3/24/2009

Number of Print Pages: 10
Number of Figures: 1
Number of Tables: 4

ISSN: 0033-3190 (Print)
eISSN: 1423-0348 (Online)

For additional information: http://www.karger.com/PPS


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Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in goverment regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
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