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Does Inclusion of a Placebo Arm Influence Response to Active Antidepressant Treatment in Randomized Controlled Trials?
- Source :
- The Journal of Clinical Psychiatry. 71:270-279
- Publication Year :
- 2010
- Publisher :
- Physicians Postgraduate Press, Inc, 2010.
-
Abstract
- OBJECTIVE To determine if the inclusion of a placebo arm and/or the number of active comparators in antidepressant trials influences the response rates of the active medication and/or placebo. DATA SOURCES Searches of MEDLINE, PsycINFO, and pharmaceutical Web sites for published trials or trials conducted but unpublished between January 1996 and October 2007. STUDY SELECTION 2,275 citations were reviewed, 285 studies were retrieved, and 90 were included in the analysis. Trials reporting response and/or remission rates in adult subjects treated with an antidepressant monotherapy for unipolar major depression were included. DATA EXTRACTION The primary investigator recorded the number of responders and/or remitters in the intent-to-treat population of each study arm or computed these numbers using the quoted rates. DATA SYNTHESIS Poisson regression analyses demonstrated that mean response rate for the active medication was higher in studies comparing 2 or more active medications without a placebo arm than in studies comparing 2 or more active medications with a placebo arm (65.4% vs 57.7%, P < .0001) or in studies comparing only 1 active medication with placebo (65.4% vs 51.7%, P = .0005). Mean response rate for placebo was significantly lower in studies comparing 1 rather than 2 or more active medications (34.3% vs 44.6%, P = .003). Mean remission rates followed a similar pattern. Meta-analysis confirmed results from the pooled analysis. CONCLUSIONS These data suggest that antidepressant response rates in randomized control trials may be influenced by the presence of a placebo arm and by the number of treatment arms and that placebo response rates may be influenced by the number of active treatment arms in a study.
- Subjects :
- Adult
Research design
medicine.medical_specialty
Population
Placebo
law.invention
Placebos
symbols.namesake
Pharmacotherapy
Double-Blind Method
Meta-Analysis as Topic
Randomized controlled trial
law
Internal medicine
Humans
Medicine
Poisson regression
education
Psychiatry
Randomized Controlled Trials as Topic
Psychiatric Status Rating Scales
Depressive Disorder, Major
education.field_of_study
business.industry
Patient Selection
Remission Induction
Placebo Effect
Antidepressive Agents
Clinical trial
Psychiatry and Mental health
Treatment Outcome
Research Design
Meta-analysis
symbols
Regression Analysis
business
Subjects
Details
- ISSN :
- 01606689
- Volume :
- 71
- Database :
- OpenAIRE
- Journal :
- The Journal of Clinical Psychiatry
- Accession number :
- edsair.doi.dedup.....229ead0fca2ddf639ef76b6f559b68f0