A randomized double-blind, placebo-controlled pilot trial of mirtazapine for anxiety in children and adolescents with autism spectrum disorder.

Autor: McDougle CJ; Massachusetts General Hospital, 55 Fruit St, Boston, MA, 02114, USA. cmcdougle@mgh.harvard.edu.; Lurie Center for Autism, 1 Maguire Road, Lexington, MA, 02421, USA. cmcdougle@mgh.harvard.edu.; Department of Psychiatry, Harvard Medical School, 25 Shattuck St, Boston, MA, 02115, USA. cmcdougle@mgh.harvard.edu., Thom RP; Massachusetts General Hospital, 55 Fruit St, Boston, MA, 02114, USA.; Lurie Center for Autism, 1 Maguire Road, Lexington, MA, 02421, USA.; Department of Psychiatry, Harvard Medical School, 25 Shattuck St, Boston, MA, 02115, USA., Ravichandran CT; Massachusetts General Hospital, 55 Fruit St, Boston, MA, 02114, USA.; Lurie Center for Autism, 1 Maguire Road, Lexington, MA, 02421, USA.; Department of Psychiatry, Harvard Medical School, 25 Shattuck St, Boston, MA, 02115, USA.; McLean Hospital, 115 Mill St, Belmont, MA, 02478, USA., Palumbo ML; Massachusetts General Hospital, 55 Fruit St, Boston, MA, 02114, USA.; Lurie Center for Autism, 1 Maguire Road, Lexington, MA, 02421, USA.; Department of Pediatrics, Harvard Medical School, 25 Shattuck St, Boston, MA, 02115, USA., Politte LC; WakeMed Children's Pediatric Behavioral Health, 3000 New Bern Ave, Raleigh, NC, 27610, USA.; Department of Psychiatry, University of North Carolina, Chapel Hill, USA., Mullett JE; Massachusetts General Hospital, 55 Fruit St, Boston, MA, 02114, USA.; Lurie Center for Autism, 1 Maguire Road, Lexington, MA, 02421, USA., Keary CJ; Massachusetts General Hospital, 55 Fruit St, Boston, MA, 02114, USA.; Lurie Center for Autism, 1 Maguire Road, Lexington, MA, 02421, USA.; Department of Psychiatry, Harvard Medical School, 25 Shattuck St, Boston, MA, 02115, USA., Erickson CA; Division of Child and Adolescent Psychiatry, Cincinnati Children's Hospital Medical Center and the University of Cincinnati College of Medicine Department of Psychiatry and Behavioral Neuroscience, Cincinnati, USA., Stigler KA; Department of Psychiatry, Indiana University School of Medicine, Indianapolis, USA., Mathieu-Frasier L; Division of Child and Adolescent Psychiatry, Cincinnati Children's Hospital Medical Center and the University of Cincinnati College of Medicine Department of Psychiatry and Behavioral Neuroscience, Cincinnati, USA., Posey DJ; Department of Psychiatry, Indiana University School of Medicine, Indianapolis, USA.
Jazyk: angličtina
Zdroj: Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology [Neuropsychopharmacology] 2022 May; Vol. 47 (6), pp. 1263-1270. Date of Electronic Publication: 2022 Mar 03.
DOI: 10.1038/s41386-022-01295-4
Abstrakt: This study was a 10-week double-blind, placebo-controlled pilot trial of mirtazapine for anxiety in youth with autism spectrum disorder (ASD). Participants were ages 5 to 17 years with ASD and clinically significant anxiety (Pediatric Anxiety Rating Scale [PARS] score ≥10). Thirty participants were randomized to mirtazapine (7.5-45 mg/day) or placebo in a 2:1 ratio. The co-primary outcome measures were the PARS and the Clinical Global Impressions-Improvement subscale (CGI-I). Mirtazapine resulted in a statistically significant within group decrease in anxiety on the PARS (ES 1.76, p < 0.001). The improvement in PARS score for mirtazapine versus placebo was clinically meaningful but not statistically significant (ES = 0.63, p = 0.64). Forty-seven percent of participants assigned to mirtazapine (95% CI 22%: 74%) and 20% assigned to placebo (95% CI 2%: 60%) were rated "much improved" (CGI-I = 2) or "very much improved" (CGI-I = 1) for anxiety, p = 0.46. No statistically significant differences in mean 10-week changes between mirtazapine and placebo occurred on any outcome measure. There were no statistically significant differences in adverse effect frequency between mirtazapine and placebo. The results are consistent with mirtazapine's safety and tolerability and meet three of four pre-specified indicators of efficacy (statistically significant change in total PARS score for mirtazapine, numerically greater reduction in total PARS score for mirtazapine than placebo, numerically higher number of responders to mirtazapine than placebo, but not greater than 50% of participants receiving mirtazapine rated as responders). Implementation of a larger randomized controlled trial of mirtazapine for the treatment of anxiety in this population is supported.Clinical trial registration information: Mirtazapine Treatment of Anxiety in Children and Adolescents with Pervasive Developmental Disorders; https://clinicaltrials.gov ; NCT01302964.
(© 2022. The Author(s), under exclusive licence to American College of Neuropsychopharmacology.)
Databáze: MEDLINE
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