Trial reportScientific reports2025
Anxiety, repetitive and restricted behaviors and interests, and social communication in autistic adults: an exploratory analysis of a phase 3, randomized clinical trial.
Trial report in Scientific reports, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03504917 (A Phase III, Randomized, Double-Blind, Placebo-Controlled, Efficacy, and Safety Study of Balovaptan in Adults With Autism Spectrum Disorder With a 2-Year Open-Label Extension), which is not on this map. Not yet cited in PubMed.
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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.
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Efficacy, and Safety Study of Balovaptan in Adults With Autism Spectrum Disorder With a 2-Year Open-Label Extension
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9 authors.
Funding
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Abstract
Autistic adults are highly vulnerable to mental health problems and yet, our understanding of co-occurring psychiatric disorders in this population is limited. Anxiety is one of the most pervasive psychiatric disorders that affects autistic adults. Here, we investigated the association between anxiety, restricted and repeated behaviors and interests (RRB), and challenges in social communication and interaction (CSCI) as a post-hoc analysis of a large Phase 3 clinical trial (NCT03504917). The study enrolled 322 adults (64 females, age 27 ± 10) assessed at baseline and weeks 12, 24, 36, and 52, with the Hamilton Anxiety Rating Scale, the Repetitive Behaviors Scale - Revised, and the Vineland-II for CSCI. All analyses were blind to treatment assignment as the primary study analysis had found no treatment effects. Anxiety levels were significantly correlated with RRB and CSCI at baseline (RRB: r = 0.19, P < 10
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