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

NCT01302964 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-11-07

Study results available
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Summary

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

Conditions

  • Autism Spectrum Disorders

Interventions

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.

Sponsors & Collaborators

  • Autism Speaks

    collaborator OTHER

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Christopher J. McDougle, M.D. · Indiana University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2017-10-10
Completion
2017-10-10

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01302964 on ClinicalTrials.gov