Mirtazapine Treatment of Anxiety in Children and Adolescents With Pervasive Developmental Disorders

Summary

This study will determine the effectiveness of mirtazapine in reducing anxiety in children with autistic disorder, Asperger's disorder and Pervasive Developmental Disorder.

Timeline

Start

2010-08

Primary completion

2017-10-10

Completion

2017-10-10

Outcome

Missed primary endpoint

paper The improvement in PARS score for mirtazapine versus placebo was clinically meaningful but not statistically significant (ES = 0.63, p = 0.64). PMID 35241779 ↗

paper 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. PMID 35241779 ↗

Publications

• McDougle CJ, Thom RP, Ravichandran CT, Palumbo ML, Politte LC, Mullett JE, Keary CJ, Erickson CA, Stigler KA, Mathieu-Frasier L, Posey DJ. A randomized double-blind, placebo-controlled pilot trial of mirtazapine for anxiety in children and adolescents with autism spectrum disorder. Neuropsychopharmacology. 2022 May;47(6):1263-1270. doi: 10.1038/s41386-022-01295-4. Epub 2022 Mar 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mirtazapine	Other / unclassified	45 mg	—

Indications