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Meta-Analysis: Pediatric Placebo Response in Depression Trials Does Not Replicate in Anxiety and Obsessive-Compulsive
Madeeha Nasir1, Fenghua Li1, Samantha Courley1
1Yale Child Study Center, Yale University School of Medicine, New Haven, Connecticut, USA.
Insights
Pediatric placebo response varies by disorder and influences antidepressant trial success. Minimizing study sites may reduce placebo effects across conditions, with specific strategies for depression, anxiety, and obsessive-compulsive disorder (OCD).
Area of Science:
- Psychiatry and Behavioral Science
- Clinical Trial Methodology
- Pediatric Psychopharmacology
Background:
- Placebo response is a critical factor in adult antidepressant trial outcomes.
- Limited research exists on placebo response in pediatric populations.
- Understanding pediatric placebo response is crucial for designing effective child psychopharmacological trials.
Purpose of the Study:
- To investigate the magnitude and predictors of placebo response in pediatric antidepressant trials.
- To examine disorder-specific and transdiagnostic factors influencing placebo response in depression, anxiety, and obsessive-compulsive disorder (OCD).
- To identify strategies for minimizing placebo effects in pediatric clinical trials.
Main Methods:
- Systematic PubMed search of pediatric antidepressant randomized controlled trials (RCTs) for depression, anxiety, or OCD.
- Meta-analysis using a random-effects model to assess placebo symptom improvement (Standardized Mean Difference) and response rates.
- Stratified subgroup analyses by diagnostic indication and meta-regression to explore correlates of placebo response.
Main Results:
- Thirty trials with 2911 participants were included; placebo improvement varied significantly across disorders.
- Placebo response was greatest in depression (SMD=1.44), followed by anxiety disorders (SMD=1.09), and lowest in OCD (SMD=0.71).
- Predictors of placebo response differed by indication; minimizing study sites may reduce placebo improvement across disorders.
Conclusions:
- The magnitude and predictors of placebo response in pediatric depression trials are not consistent across anxiety and OCD.
- Strategies like minimizing study sites, increasing enrollment per site, reducing visits, and U.S. site selection may decrease placebo response.
- Further research is needed to elucidate predictors of placebo response in pediatric anxiety and OCD.
Abstract:
Placebo response has been identified as an important factor influencing the success of adult antidepressant trials, yet little research of placebo response has been conducted in pediatric populations. Understanding disorder-specific and transdiagnostic predictors of pediatric placebo response is important in designing successful child psychopharmacological trials. A PubMed search was conducted for all pediatric antidepressant randomized controlled trials treating depression, anxiety, or obsessive-compulsive disorder (OCD). A random-effects model was utilized to examine the magnitude of placebo symptom improvement using standardized mean difference (SMD) and placebo response rates. Stratified subgroup analysis was performed by diagnostic indication. Meta-regression was utilized to search possible correlates of placebo symptom improvement and placebo response rate. Thirty antidepressant trials involving 2911 participants receiving placebo were included in this meta-analysis. Magnitude of placebo improvement and placebo response rates varied significantly across disorders; being greater in depression (SMD = 1.44, 95% confidence interval [CI]: 1.18 to 1.71) than anxiety disorders (SMD = 1.09, 95% CI: 0.77 to 1.41) and the lowest in OCD (SMD = 0.71, 95% CI: 0.32 to 1.12). Different predictors were associated with placebo response in different indications. Both the magnitude and predictors of placebo response in pediatric depression trials do not replicate across anxiety and OCD. Based on our results, across disorders, minimizing the number of sites might significantly reduce placebo improvement. In addition to these, we could potentially decrease the placebo response in depression trials by increasing the number of subjects enrolled per study site, minimizing the number of study visits and conducting the studies in the United States. Further research is needed into the predictors of placebo response in pediatric anxiety and OCD.
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