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

Autism Spectrum Disorders research study

What is the primary objective of this study?

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

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Autism Spectrum Disorders

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:PlaceboSubjects randomized to placebo will receive placebo for duration of the study

Drug:MirtazapineSubjects 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

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

Study Status


Start Date: August 2010

Completed Date: October 10, 2017

Phase: Phase 3

Type: Interventional


Primary Outcome: Mean 10-Week Change in Pediatric Anxiety Rating Scale 5-Item Total Score, Double-blind Phase

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Christopher J. McDougle, M.D.

Lead Sponsor: Massachusetts General Hospital

Collaborator: Autism Speaks

More information:

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