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

Mass General Brigham

Status and phase: Completed; Phase 3

Conditions: Autism Spectrum Disorders

Treatments: Drug: Placebo; Drug: Mirtazapine

Study type: Interventional

Funder types: Other

Identifiers

NCT01302964

2012P001009

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Mirtazapine

Experimental group

Description:

The starting dose for subjects is 7.5 mg daily. The maximum daily dose will be 45 mg.

Treatment:

Drug: Mirtazapine

Placebo

Placebo Comparator group

Description:

Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain inactive ingredients.

Treatment:

Drug: Placebo