NCT01302964

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Autism Spectrum Disorders

Interventions

Type	Name	Description
DRUG	Placebo	Subjects randomized to placebo will receive placebo for duration of the study
DRUG	Mirtazapine	Subjects will receive 7.5 mg daily at the start of the trial. The dose will be increased by 7.5 mg per week for subjects weighing less than 50 kg and up to 15 mg per week for subjects weighing more than 50 kg depending on efficacy and tolerability.

Timeline

• Start date: 2010-08-01
• Primary completion: 2017-10-10
• Completion: 2017-10-10
• First posted: 2011-02-24
• Last updated: 2018-11-07
• Results posted: 2018-11-07

Locations

2 sites across 1 country: United States