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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 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: March 13, 2016
Last verified: March 2016

August 25, 2010
March 13, 2016
August 2010
July 2018   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01302964 on ClinicalTrials.gov Archive Site
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Mirtazapine Treatment of Anxiety in Children and Adolescents With Pervasive Developmental Disorders
Mirtazapine Treatment of Anxiety in Children and Adolescents With Pervasive Developmental Disorders
This study will determine the effectiveness of mirtazapine in reducing anxiety in children with autistic disorder, Asperger's disorder and Pervasive Developmental Disorder.
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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Autism Spectrum Disorders
  • Drug: Placebo
    Subjects randomized to placebo will receive placebo for duration of the study
    Other Name: Sugar pill
  • 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
  • Experimental: Mirtazapine
    The starting dose for subjects is 7.5 mg daily. The maximum daily dose will be 45 mg.
    Interventions:
    • Drug: Mirtazapine
    • Drug: Mirtazapine
  • 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.
    Intervention: Drug: Placebo
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
July 2018
July 2018   (final data collection date for primary outcome measure)

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.
Both
5 Years to 17 Years   (Child)
No
Contact: Jennifer Mullett, RN,CCRP 781-860-1711 LurieCenterResearch@partners.org
United States
 
NCT01302964
2012P00009
Yes
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Christopher John McDougle, M.D., Massachusetts General Hospital
Massachusetts General Hospital
Autism Speaks
Principal Investigator: Christopher J. McDougle, M.D. Indiana University School of Medicine
Massachusetts General Hospital
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP