ArticleJournal of autism and developmental disorders2025
Placebo Effect in Clinical Trials in Autism: Experience from a Pregnenolone Treatment Study.
Article in Journal of autism and developmental disorders, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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
1 citing paper in PubMed.
- Medical treatment of autism spectrum disorder in children: Current evidence, controversies, and clinical challenges.World journal of clinical pediatrics · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
Abstract
purposeThe placebo effect is a significant limitation in subjective report, particularly when using informant-based outcome measures. In autism spectrum disorder (ASD), this effect is particularly complex due to high expectations for positive treatment outcomes. Therefore, interventional research in ASD needs to account for and remediate the placebo response.
methodsThis preliminary pilot report examines placebo effect in a single-blind, two-week placebo lead-in that preceded the double-blind phase of a randomized controlled trial. The trial assessed pregnenolone, an endogenous neurosteroid, for reducing irritability in adolescents and young adults (ages 14-25) with ASD. The Aberrant Behaviors Checklist (ABC) irritability subscale (ABC-I) was the primary outcome measure used to identify correlates of the placebo effect (IQ, age, sex, and baseline symptom severity). Paired, 2-tailed t-tests compared outcome measures at baseline and following the lead-in.
resultsTwenty-five participants (23 males, 2 females; mean age 18.5 ± 3.1 years) have completed the trial to date. The two-week lead-in resulted in a 30.2% decrease in irritability symptoms (t(24) = 5.090(24), p < 0.001; Cohen's d = 1.018) across all participants. The remaining ABC subscales also decreased significantly. The magnitude of change in ABC-I was correlated (r
conclusionFindings from this preliminary pilot trial provide evidence of a significant placebo effect in a clinical trial for ASD, further highlighting the challenges that this phenomenon presents for interventional research. A single-blind placebo lead-in within ASD clinical trials is a recommended approach to both account and mitigate for the placebo effect.
Indexed as
Identifiers
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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.