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

Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Autism Spectrum Disorders

Intervention: Placebo (Drug); Mirtazapine (Drug); Mirtazapine (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Massachusetts General Hospital

Official(s) and/or principal investigator(s):
Christopher J. McDougle, M.D., Principal Investigator, Affiliation: Indiana University School of Medicine

Overall contact:
Jennifer Mullett, RN,CCRP, Phone: 781-860-1711, Email: LurieCenterResearch@partners.org

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Pediatric Anxiety Rating Scale (PARS)

Clinical Global Impressions (CGI)

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.

Eligibility

Minimum age: 5 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Jennifer Mullett, RN,CCRP, Phone: 781-860-1711, Email: LurieCenterResearch@partners.org

Riley Child and Adolescent Psychiatry Clinic Riley Hospital, Indianapolis, Indiana 46202, United States; Completed

Lurie Center -MassGeneral Hospital, Lexington, Massachusetts 02421, United States; Recruiting
Jennifer Mullett, RN,CCRP, Phone: 781-860-1711, Email: LurieCenterResearch@partners.org
Christopher J McDougle, MD, Principal Investigator

Additional Information

Lurie Center Research

Starting date: August 2010
Last updated: June 4, 2015

Page last updated: August 23, 2015

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