Phase 3
N=30
Mirtazapine Treatment of Anxiety in Children and Adolescents With Pervasive Developmental Disorders
Autism Spectrum Disorders
Bottom Line
View on ClinicalTrials.gov: NCT01302964 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: Mean 10-Week Change in Pediatric Anxiety Rating Scale 5-Item Total Score, Double-blind Phase — -4.9; -3.2 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Drug); Mirtazapine (Drug)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Oct 2017
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 | — |
Summary
This study will determine the effectiveness of mirtazapine in reducing anxiety in children with autistic disorder, Asperger's disorder and Pervasive Developmental Disorder.
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). 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.