Does the increasing placebo response impact outcomes of adult and pediatric ADHD clinical trials? Data from the US Food and Drug Administration 2000–2009

In a study of recent antidepressant clinical trial data, it was found placebo response had grown significantly over time and that contrary to expectations, trial outcome measures and success rate were not impacted. The aim of this paper was to evaluate if this trend of increasing placebo response an...

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Bibliographic Details
Published in:Journal of psychiatric research 2017-11, Vol.94, p.202-207
Main Authors: Khan, Arif, Fahl Mar, Kaysee, Brown, Walter A.
Format: Article
Language:English
Subjects:
ADHD
Adolescent
Adrenergic alpha-2 Receptor Agonists - pharmacology
Adult
Age Factors
Aged
Attention Deficit Disorder with Hyperactivity - drug therapy
Central Nervous System Stimulants - pharmacology
Child
Clinical trials
Controlled Clinical Trials as Topic - statistics & numerical data
Effect size
Female
Humans
Male
Middle Aged
Outcome Assessment (Health Care) - statistics & numerical data
Placebo Effect
Placebo response
Placebos - pharmacology
United States
United States Food and Drug Administration - statistics & numerical data
Young Adult
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Summary:In a study of recent antidepressant clinical trial data, it was found placebo response had grown significantly over time and that contrary to expectations, trial outcome measures and success rate were not impacted. The aim of this paper was to evaluate if this trend of increasing placebo response and stable outcome measures could be seen in clinical trial data for Attention-Deficit Hyperactivity Disorder, a different psychiatric condition with susceptibility to placebo response. For this reason, we evaluated efficacy data reported in the FDA Medical and Statistical reviews for 10 ADHD medication programs (4917 patients, 17 trials, 29 treatment arms). Placebo and medication response were measured as percent symptom reduction and effect sizes and drug-placebo differences were calculated for each treatment arm and analyzed in relation to year of approval. We also investigated the potential role of age and medication class on trends and outcomes. Results showed a similar pattern to antidepressants wherein the placebo response is rising significantly over time (r = 0.636, p = 0.006) and effect size (r 
ISSN:0022-3956
1879-1379
DOI:10.1016/j.jpsychires.2017.07.018