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

Completed · Phase 3 · Has a placebo group

Conditions studied: Autism Spectrum Disorders

In brief

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

Key facts

Study ID

NCT01302964

Run by

Massachusetts General Hospital

People needed

30

Starts

2010-08-01

Expected to finish

2017-10-10

Last updated by the study team

2018-11-07

Who can join

Age: 5 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Riley Child and Adolescent Psychiatry Clinic Riley Hospital — Indianapolis, Indiana, United States
• Lurie Center -MassGeneral Hospital — Lexington, Massachusetts, United States

Full record on ClinicalTrials.gov

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