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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Massachusetts General Hospital
Sponsor:
Collaborator:
Autism Speaks
Information provided by (Responsible Party):
Christopher John McDougle, M.D., Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01302964
First received: August 25, 2010
Last updated: October 22, 2012
Last verified: October 2012
  Purpose

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


Condition Intervention Phase
Autism Spectrum Disorders
Drug: Placebo
Drug: Mirtazapine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mirtazapine Treatment of Anxiety in Children and Adolescents With Pervasive Developmental Disorders

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Pediatric Anxiety Rating Scale (PARS) [ Time Frame: Collected at screen (Visit 1) baseline (Visit 2) and endpoint (Week 10) ] [ Designated as safety issue: No ]
    Assesses severity across common anxiety disorders in children including generalized anxiety, social anxiety, separation anxiety and transition-associated anxiety.

  • Clinical Global Impressions (CGI) [ Time Frame: Screen (Visit 1) Baseline (Visit 2) and Endpoint (Week 10) ] [ Designated as safety issue: No ]
    The CGI is designed to take into account all factors to arrive at an assessment of severity and response to treatment.


Estimated Enrollment: 30
Study Start Date: August 2010
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mirtazapine
The starting dose for subjects is 7.5 mg daily. The maximum daily dose will be 45 mg.
Drug: Mirtazapine
Subjects will receive 7.5 mg daily at the start of the trial. The dose will be increased by 7.5 mg weekly for subject weighing less than 5 50kg and up to 15 mg weekly for subjects weighing more than 50kg depending upon efficacy and tolerability.
Other Name: Geodon
Drug: Mirtazapine
Subjects will receive 7.5 mg of mirtazapine daily initially. The dose will be increased by 7.5 mg for subjects weighing less than 50kg and up to 15 mg per week for subjects weighing more than 50kg. depending upon efficacy and tolerability.
Other Name: Geodon
Placebo Comparator: Placebo
Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain inactive ingredients.
Drug: Placebo
Subjects randomized to placebo will receive placebo for duration of the study
Other Name: Sugar pill

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

Ages Eligible for Study:   5 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01302964

Contacts
Contact: Jennifer Mullett, RN,CCRP 781-860-1711 LurieCenterResearch@partners.org

Locations
United States, Indiana
Riley Child and Adolescent Psychiatry Clinic Riley Hospital Completed
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Lurie Center -MassGeneral Hospital Recruiting
Lexington, Massachusetts, United States, 02421
Contact: Jennifer Mullett, RN,CCRP    781-860-1711    LurieCenterResearch@partners.org   
Principal Investigator: Christopher J McDougle, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Autism Speaks
Investigators
Principal Investigator: Christopher J. McDougle, M.D. Indiana University School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Christopher John McDougle, M.D., Director, Lurie Center for Autism, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01302964     History of Changes
Other Study ID Numbers: 2012P00009
Study First Received: August 25, 2010
Last Updated: October 22, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Autistic Disorder
Asperger's Disorder
Pervasive Developmental Disorder

Additional relevant MeSH terms:
Autistic Disorder
Developmental Disabilities
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Mirtazapine
Mianserin
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Serotonin Antagonists
Serotonin Agents
Antidepressive Agents, Second-Generation

ClinicalTrials.gov processed this record on July 20, 2014