ArticleNeuropsychopharmacology : official publication of the American College of Neuropsychopharmacology2023
Predictors of placebo response in three large clinical trials of the V1a receptor antagonist balovaptan in autism spectrum disorder.
Article in Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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Who cites it
10 citing papers in PubMed.
- Predictors of Placebo Response in the Study of Oxytocin in Autism to Improve Reciprocal Social Behaviors.Journal of child and adolescent psychopharmacology · 2025Trial
- Mesenchymal stem/stromal cell-based therapies for autism spectrum disorder: emerging evidence and clinical prospects.Journal of translational medicine · 2026Review
- Novel therapeutics in autism spectrum disorder.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2026Review
- Development of the Angelman syndrome video assessment: quantifying meaningful change.Journal of neurodevelopmental disorders · 2025Article
- Placebo Effect in Clinical Trials in Autism: Experience from a Pregnenolone Treatment Study.Journal of autism and developmental disorders · 2025Article
- A Blueprint for Translational Precision Medicine in Autism Spectrum Disorder and Related Neurogenetic Syndromes.Journal of child and adolescent psychopharmacology · 2025Review
- Oxytocin in neurodevelopmental disorders: Autism spectrum disorder and Prader-Willi syndrome.Pharmacology & therapeutics · 2024Review
- Effect of the social environment on olfaction and social skills in wild-type and a mouse model of autism.Translational psychiatry · 2024Article
- Decoding the impact of the placebo response in clinical trials for chronic cough.ERJ open research · 2024Article
- Mediators of Placebo Response to Cannabinoid Treatment in Children with Autism Spectrum Disorder.Journal of clinical medicine · 2023Article
Corrections and comments
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Authors and funding
7 authors.
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No grant is acknowledged in the PubMed record.
Abstract
High rates of placebo response are increasingly implicated in failed autism spectrum disorder (ASD) clinical trials. Despite this, there are limited investigations of placebo response in ASD. We sought to identify baseline predictors of placebo response and quantify their influence on clinical scales of interest for three harmonized randomized clinical trials of balovaptan, a V1a receptor antagonist. We employed a two-step approach to identify predictors of placebo response on the Vineland-II two-domain composite (2DC) (primary outcome and a caregiver measure) and Clinical Global Impression (CGI) scale (secondary outcome and a clinician measure). The initial candidate predictor set of variables pertained to participant-level, site-specific, and protocol-related factors. Step 1 aimed to identify influential predictors of placebo response using Least Absolute Shrinkage and Selection Operator (LASSO) regression, while Step 2 quantified the influence of predictors via linear regression. Results were validated through statistical bootstrapping approaches with 500 replications of the analysis dataset. The pooled participant-level dataset included individuals with ASD aged 5 to 62 years (mean age 21 [SD 10]), among which 263 and 172 participants received placebo at Weeks 12 and 24, respectively. Although no influential predictors were identified for CGI, findings for Vineland-II 2DC are robust and informative. Decreased placebo response was predicted by higher baseline Vineland-II 2DC (i.e., more advanced adaptive function), longer trial duration, and European (vs United States) sites, while increased placebo response was predicted by commercial (vs academic) sites, attention deficit hyperactivity disorder and depression. Identification of these factors may be useful in anticipating and mitigating placebo response in drug development efforts in ASD and across developmental and psychiatric conditions.
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