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

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.

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