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

Last updated: October 10, 2018
Sponsor: Massachusetts General Hospital
Overall Status: Completed

Phase

3

Condition

Autism

Birth Defects

Autism Spectrum Disorder (Asd)

Treatment

N/A

Clinical Study ID

NCT01302964
2012P001009
  • Ages 5-17
  • All Genders

Study 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

Inclusion Criteria:

  • Ages 5-17 years

  • Diagnosis of autistic disorder, Asperger's disorder or Pervasive DevelopmentalDisorder 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

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 withmirtazapine unsafe

  • Use of other antidepressants or benzodiazepines

  • Use of other psychotropic medications which are ineffective, poorly tolerated, orsub-optimal in terms of dose

  • Previous adequate trial of mirtazapine

Study Design

Total Participants: 30
Study Start date:
August 01, 2010
Estimated Completion Date:
October 10, 2017

Study Description

One of the areas receiving very little attention in Pervasive Developmental Disorders (PDDs) is that of anxiety. Anxiety is common in PDD, but has not yet been fully characterized. The primary objective of this study is to conduct a preliminary placebo-controlled trial of mirtazapine for the treatment of anxiety associated with PDDs. We hypothesize that mirtazapine will be safe and well tolerated.

Connect with a study center

  • Riley Child and Adolescent Psychiatry Clinic Riley Hospital

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Lurie Center -MassGeneral Hospital

    Lexington, Massachusetts 02421
    United States

    Site Not Available

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