Efficacy and Safety of Aripiprazole in Children and Adolescents With Autism Spectrum Disorder: A Meta-Analysis


Kilinçel Ş., Bulut F., Kilinçel O.

Journal of Nervous and Mental Disease, 2026 (SCI-Expanded, SSCI, Scopus) identifier identifier identifier

  • Yayın Türü: Makale / Tam Makale
  • Basım Tarihi: 2026
  • Doi Numarası: 10.1097/nmd.0000000000001874
  • Dergi Adı: Journal of Nervous and Mental Disease
  • Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Social Sciences Citation Index (SSCI), Scopus, Abstracts in Social Gerontology, ATLA Religion Database, BIOSIS, CINAHL, Educational research abstracts (ERA), EMBASE, MEDLINE, MLA - Modern Language Association Database, Psycinfo, MLA International Bibliography, Academic Search Ultimate (EBSCO), Health Research Premium Collection (ProQuest)
  • Anahtar Kelimeler: adverse events, aripiprazole, Autism spectrum disorder, irritability, meta-analysis
  • İstanbul Gelişim Üniversitesi Adresli: Evet

Özet

Aim: – Aripiprazole is one of the few pharmacological agents approved for managing irritability in children and adolescents with autism spectrum disorder (ASD). Methods: – Randomized controlled trials comparing oral aripiprazole with placebo or active drugs in participants under 18 years were systematically searched in major databases through September 2025 (last search: September 15, 2025). The primary outcome was change in Aberrant Behavior Checklist–Irritability (ABC-I) scores; data were synthesized using random-effects models. Results: – Eleven trials (N = 1, 135) were included. Aripiprazole significantly reduced irritability (mean difference = −5.18; 95% CI = −6.72 to −3.64; I2 = 0%) and improved global ratings versus placebo. Common adverse effects were weight gain, sedation, and extrapyramidal symptoms, though discontinuation rates were comparable to placebo. Conclusions: – Aripiprazole effectively and safely reduces irritability in pediatric ASD. Although adverse effects are frequent, they are generally manageable, supporting individualized dosing and long-term monitoring.