ArticleMolecular autism2022
Large multicenter randomized trials in autism: key insights gained from the balovaptan clinical development program.
Article in Molecular autism, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
10 citing papers in PubMed, 19 citations in OpenAlex.
- AST-001 versus placebo for social communication in children with autism spectrum disorder: A randomized clinical trial.Psychiatry and clinical neurosciences · 2025Trial
- Vasopressin 1a Receptor Antagonists for Pathological Aggression in Neurodegenerative and Other CNS Diseases.Biomedicines · 2026Review
- 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
- Placebo Effect in Clinical Trials in Autism: Experience from a Pregnenolone Treatment Study.Journal of autism and developmental disorders · 2025Article
- Available Treatments for Autism Spectrum Disorder: From Old Strategies to New Options.Pharmaceuticals (Basel, Switzerland) · 2025Review
- Oxytocin and its links through scientific lineage.Comprehensive psychoneuroendocrinology · 2024Article
- Predictors of placebo response in three large clinical trials of the V1a receptor antagonist balovaptan in autism spectrum disorder.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2023Article
- Mediators of Placebo Response to Cannabinoid Treatment in Children with Autism Spectrum Disorder.Journal of clinical medicine · 2023Article
- Commentary: Research status and prospects of acupuncture for autism spectrum disorders.Frontiers in psychiatry · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors at 13 institutions in 4 countries.
Funding
Abstract
backgroundAutism spectrum disorder (ASD) is a common and heterogeneous neurodevelopmental condition that is characterized by the core symptoms of social communication difficulties and restricted and repetitive behaviors. At present, there is an unmet medical need for therapies to ameliorate these core symptoms in order to improve quality of life of autistic individuals. However, several challenges are currently faced by the ASD community relating to the development of pharmacotherapies, namely in the conduct of clinical trials. Balovaptan is a V1a receptor antagonist that has been investigated to improve social communication difficulties in individuals with ASD. In this viewpoint, we draw upon our recent first-hand experiences of the balovaptan clinical development program to describe current challenges of ASD trials. DISCUSSION POINTS: The balovaptan trials were conducted in a wide age range of individuals with ASD with the added complexities associated with international trials. When summarizing all three randomized trials of balovaptan, a placebo response was observed across several outcome measures. Placebo response was predicted by greater baseline symptom severity, online recruitment of participants, and less experienced or non-academic trial sites. We also highlight challenges relating to selection of outcome measures in ASD, the impact of baseline characteristics, and the role of expectation bias in influencing trial results.
conclusionTaken together, the balovaptan clinical development program has advanced our understanding of the key challenges facing ASD treatment research. The insights gained can be used to inform and improve the design of future clinical trials with the collective aim of developing efficacious therapies to support individuals with ASD.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.