Trial reportPsychopharmacology2012
Paliperidone for irritability in adolescents and young adults with autistic disorder.
Trial report in Psychopharmacology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00549562 (A Prospective, Open-Label Study of Paliperidone ER in Adolescents and Young Adults With Autism), which is not on this map. Cited by 27 papers, 2 of them syntheses that pooled it.
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.
A Prospective, Open-Label Study of Paliperidone ER in Adolescents and Young Adults With Autism
Who cites it
27 citing papers in PubMed, 2 syntheses or guidelines pooled it, 73 citations in OpenAlex.
- Safety and Tolerability of Antipsychotic Medication in Individuals with Autism Spectrum Disorder: A Systematic Review and Meta-Analysis.Paediatric drugs · 2019Pooled it
- Incontinence in autism spectrum disorder: a systematic review.European child & adolescent psychiatry · 2018Pooled it
- Brief report: an open-label study of the neurosteroid pregnenolone in adults with autism spectrum disorder.Journal of autism and developmental disorders · 2014Trial
- Medical treatment of autism spectrum disorder in children: Current evidence, controversies, and clinical challenges.World journal of clinical pediatrics · 2026Article
- Safety and Efficacy of Paliperidone Palmitate in Pediatric Patients with Autism and Intellectual Disability.Journal of autism and developmental disorders · 2026Article
- Pharmacological Interventions in Autism Spectrum Disorder: A Comprehensive Review of Mechanisms and Efficacy.Biomedicines · 2025Review
- Article
- Psychiatric Adverse Effects From Prucalopride in a Medically Complex Adolescent.Case reports in pediatrics · 2025Article
- A perspective on molecular signalling dysfunction, its clinical relevance and therapeutics in autism spectrum disorder.Experimental brain research · 2022Review
- Pharmacotherapy of Disruptive Behaviors in Children with Intellectual Disabilities.Paediatric drugs · 2022Review
- Signalling pathways in autism spectrum disorder: mechanisms and therapeutic implications.Signal transduction and targeted therapy · 2022Review
- Serotonin Receptors as Therapeutic Targets for Autism Spectrum Disorder Treatment.International journal of molecular sciences · 2022Review
- Management of Emotion Dysregulation and Outbursts in Children and Adolescents.Current psychiatry reports · 2022Review
- Decades of Progress in the Psychopharmacology of Autism Spectrum Disorder.Journal of autism and developmental disorders · 2021Article
- Recent Advances in the Pharmacological Management of Behavioral Disturbances Associated with Autism Spectrum Disorder in Children and Adolescents.Paediatric drugs · 2020Review
- Management of Self-injurious Behaviors in Children with Neurodevelopmental Disorders: A Pharmacotherapy Overview.Pharmacotherapy · 2019Review
- Pharmacotherapy of emotional and behavioral symptoms associated with autism spectrum disorder in children and adolescents.Dialogues in clinical neuroscience · 2017Review
- Aggression in autism spectrum disorder: presentation and treatment options.Neuropsychiatric disease and treatment · 2016Review
- Irritability and Severity of Anxious Symptomatology Among Youth With Anxiety Disorders.Journal of the American Academy of Child and Adolescent Psychiatry · 2016Article
- Atypical antipsychotics in the treatment of children and adolescents with pervasive developmental disorders.Psychopharmacology · 2014Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 3 institutions in 1 country.
Funding
Abstract
rationaleIndividuals with autistic disorder (autism) frequently exhibit significant irritability marked by severe tantrums, aggression, and self-injury. Despite advances in the treatment of this symptom domain in autism, there remains an ongoing need for more effective and better tolerated pharmacotherapies.
objectivesThe aim of this study is to determine the effectiveness and tolerability of paliperidone for irritability in autism.
methodsThis is a prospective, 8-week open-label study of paliperidone in 25 adolescents and young adults with autism. Primary outcome measures included the Clinical Global Impressions-Improvement (CGI-I) Scale and the Irritability subscale of the Aberrant Behavior Checklist (ABC-I). Concomitant medications (except antipsychotics) were permitted if dosages were stable for ≥2 months.
resultsTwenty-one (84 %) of 25 subjects ages 12-21 years (mean 15.3 years) responded to paliperidone, based on a CGI-I Scale score of 1 or 2 (very much or much improved) and ≥25 % improvement on the ABC-I. The mean final dosage of paliperidone was 7.1 mg/day (range 3-12 mg/day). Two subjects discontinued paliperidone prior to study completion (moderate sedation, n = 1; nonresponse, n = 1). Mild-to-moderate extrapyramidal symptoms were recorded in four subjects. A mean weight gain of 2.2 ± 2.6 kg (range -3.6 to +7.9 kg) was recorded. Mean age- and sex-normed body mass index increased from 23.6 to 24.2 (p ≤ 0.001). Mean serum prolactin increased from 5.3 to 41.4 ng/mL (p ≤ 0.0001).
conclusionsPaliperidone treatment was associated with significant improvement in irritability and was generally well tolerated. Larger scale, placebo-controlled studies are needed to elucidate the efficacy and tolerability of paliperidone in this population.
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.