Phase 3
Completed N=30
Mirtazapine Treatment of Anxiety in Children and Adolescents With Pervasive Developmental Disorders
Source: ClinicalTrials.gov NCT01302964 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcomePrimary: Mean 10-Week Change in Pediatric Anxiety Rating Scale 5-Item Total Score, Double-blind Phase — -4.9; -3.2 score on a scale
◆ Published Evidence
Established
31citations · ~8 / year
A randomized double-blind, placebo-controlled pilot trial of mirtazapine for anxiety in children and adolescents with autism spectrum disorder.
Summary
This study will determine the effectiveness of mirtazapine in reducing anxiety in children with autistic disorder, Asperger's disorder and Pervasive Developmental Disorder.
Linked Publications
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A randomized double-blind, placebo-controlled pilot trial of mirtazapine for anxiety in children and adolescents with autism spectrum disorder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean 10-Week Change in Pediatric Anxiety Rating Scale 5-Item Total Score, Double-blind Phase |
-4.9; -3.2 | — |
| PRIMARY Proportion of Participants Who Responded to Treatment at 10 Weeks According to the Improvement Item of the Clinical Global Impression-Scale (Response Defined as CGI-I=1 or CGI-I=2) |
0.47; 0.20 | — |
Eligibility Criteria
Inclusion Criteria
- Ages 5-17 years
- Diagnosis of autistic disorder, Asperger's disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD NOS)
- Clinically significant anxiety as evidenced by a Pediatric Anxiety Rating Scale (PARS) score of 10 or greater
- Abbreviated intelligence quotient (IQ) greater than 50 on the Stanford Binet 5th Ed.
Exclusion Criteria
- Diagnosis of Rett's disorder or childhood integrative disorder
- Diagnosis of obsessive-compulsive disorder (OCD), post-traumatic stress disorder, major mood disorder, psychotic disorder, or substance use disorder
- Presence of any past or present medical conditions that would make treatment with mirtazapine unsafe
- Use of other antidepressants or benzodiazepines
- Use of other psychotropic medications which are ineffective, poorly tolerated, or sub-optimal in terms of dose
- Previous adequate trial of mirtazapine
Data sourced from ClinicalTrials.gov (NCT01302964) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.