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

• Status: Completed
• Trial end date: 2017-10-10
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: Autism Speaks
• Treatments: Mianserin; Mirtazapine; Ziprasidone

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