Placebo Response in Randomized Controlled Trials of Antidepressants for Pediatric Major Depressive Disorder

Bridge, Jeffrey A.; Birmaher, Boris; Iyengar, Satish; Barbe, Rémy P.; Brent, David A.

doi:10.1176/appi.ajp.2008.08020247

Cited by 256Pain Management and Placebo EffectTreatment of Major DepressionStatistical Methods in Clinical Trials

Placebo Response in Randomized Controlled Trials of Antidepressants for Pediatric Major Depressive Disorder

Bridge, Jeffrey A., Birmaher, Boris, Iyengar, Satish, Barbe, Rémy P., Brent, David A.·2009·American Journal of Psychiatry

DOI 10.1176/appi.ajp.2008.08020247

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Abstract

Objective: The authors examined characteristics and predictors of response to placebo in all available reports of short-term randomized controlled trials of antidepressants for pediatric major depressive disorder. Method: Response, defined as a score ≤2 on the improvement item of the Clinical Global Impression scale, and potential predictors were extracted from 12 published and unpublished randomized controlled trials of second-generation antidepressants in participants 6–18 years of age with major depression. Results: The single best predictor of the proportion of patients taking placebo who responded to treatment was the number of study sites. Baseline severity of illness also emerged as a significant inverse predictor of placebo response, although the strength of this relationship was diminished when number of sites was controlled for. After one large fluoxetine trial was excluded, younger participants showed a higher placebo response rate than older adolescents. Higher placebo response rates in more recent studies were explained by an increasing trend toward large multisite trials and by publication delays and failures to publish some negative trials. Conclusions: The recent shift toward large multisite trials of antidepressant medications for pediatric major depression may be contributing to an increasing incidence of response to placebo. Pharmacotherapy studies of pediatric depression that carefully recruit patients with at least moderately severe depression may be more informative and efficient than many trials conducted to date. Such studies should have sufficient power to determine whether age moderates medication and placebo response.

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Methodological issues have been previously proposed as possible reasons for negative clinical trials in MDD.
“methodological issues, including aspects of study design and conduct (i.e., issues with identifying appropriate patients, large multi-site trials, multiple raters) that have been previously proposed as possible reasons for negative clinical trials in MDD”
From A randomized, double-blind, duloxetine-referenced study comparing efficacy and tolerability of 2 fixed doses of vortioxetine in the acute treatment of adults with MDD (2015) · cites this paper as Bridge et al., 2009
Considering the substantial control group response that exercise RCTs must overcome and the absolute benefits, critiques concerning the efficacy of exercise for depression may be premature, particularly in light of other health benefits of an active lifestyle.
“Thus, considering the substantial control group response that exercise RCTs must overcome to show a benefit in depressive symptoms and the benefits in absolute terms, critiques concerning the efficacy of exercise for depression (e.g., [13]) may be premature, particularly in light of the plethora of other health benefits of an active lifestyle [10, 78, 79].”
From Challenges establishing the efficacy of exercise as an antidepressant treatment: a systematic review and meta-analysis of control group responses in exercise randomised controlled trials (2016) · cites this paper as [79]

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Authors: Bridge, J. A., Birmaher, B., Iyengar, S., Barbe, R. P., & Brent, D. A.
Affiliations: Nationwide Children's Hospital (US)
ORCID: Bridge, Jeffrey A.
Birmaher, Boris
Iyengar, Satish
Barbe, Rémy P.
Brent, David A.
Venue: American Journal of Psychiatry
Publisher: American Psychiatric Association Publishing
Published: 2009-01
Volume: 166
Issue: 1
Pages: 42-49
ISSN: 0002-953X (ISSN-L)
1535-7228
DOI: 10.1176/appi.ajp.2008.08020247
OpenAlex: W2137044513
Cited by: 256
References: 48
Citations by year: 2026: 6 · 2025: 9 · 2024: 11 · 2023: 2 · 2022: 12 · 2021: 12 · 2020: 9 · 2019: 14 · 2018: 19 · 2017: 16 · 2016: 14 · 2015: 27 · 2014: 22 · 2013: 14 · 2012: 12
FWCI: 1.40
Type: journal article
Language: en
Open access: closed
Locations: American Journal of Psychiatry (publishedVersion)
PubMed (publishedVersion)
Funders: National Institute of Mental Health (K01 MH-69948, K01MH069948, P30MH066371, P30 MH-66371)
Topics: Life Sciences › Neuroscience › Cognitive Neuroscience › Pain Management and Placebo Effect
Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Keywords: placebo response, antidepressants, second-generation antidepressants, age differences, publication bias, Clinical Global Impression Scale, multisite trials, fluoxetine
MeSH terms: Adolescent, Age Factors, Child, Major Depressive Disorder, Humans, Personality Assessment, Multicenter Studies as Topic, Placebo Effect, Randomized Controlled Trials as Topic, Treatment Outcome, Publication Bias

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Placebo Response in Randomized Controlled Trials of Antidepressants for Pediatric Major Depressive Disorder

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