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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01302964
Recruitment Status : Completed
First Posted : February 24, 2011
Results First Posted : November 7, 2018
Last Update Posted : November 7, 2018
Sponsor:
Collaborator:
Autism Speaks
Information provided by (Responsible Party):
Christopher John McDougle, M.D., Massachusetts General Hospital

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

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorders Drug: Placebo Drug: Mirtazapine Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mirtazapine Treatment of Anxiety in Children and Adolescents With Pervasive Developmental Disorders
Study Start Date : August 2010
Actual Primary Completion Date : October 10, 2017
Actual Study Completion Date : October 10, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Mirtazapine

Arms and Interventions
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Arm Intervention/treatment
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 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.
Other Name: Remeron
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


Outcome Measures
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Primary Outcome Measures :
  1. Mean 10-Week Change in Pediatric Anxiety Rating Scale 5-Item Total Score, Double-blind Phase [ Time Frame: Weeks Baseline, 2, 4, 6, and 10 ]
    The Pediatric Anxiety Rating Scale (PARS) is a clinician-rated instrument that assesses anxiety symptoms that are commonly associated with social anxiety, separation anxiety, and generalized anxiety disorders. Scaled score ranges form 0-25 with higher scores indicating more severe anxiety symptoms. Means were estimated using a repeated measures linear regression model with treatment group, study week (in categories), and their interaction as covariates, and assuming a common mean between treatment groups at baseline. Confidence intervals reflect a Bonferroni multiple testing correction accounting for the selection of two primary outcomes.

  2. Proportion of Participants Who Responded to Treatment at 10 Weeks According to the Improvement Item of the Clinical Global Impression-Scale (Response Defined as CGI-I=1 or CGI-I=2) [ Time Frame: Screen (Visit 1) Baseline (Visit 2) and Endpoint (Week 10) ]
    The Clinical Global Impressions Global Improvement (CGI-I) is designed to take into account all factors to arrive at an assessment of response to treatment. The CGI-I scale ranges from 1 to 7 (1=very much improved; 2= much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse), with lower scores indicating improvement (1=very much improved and 2=much improved). In this study the CGI was focused on the target symptom of anxiety. Participants with a CGI-I score of 1 or 2 were classified as responders. The CGI-I was administered biweekly for 6 weeks and again at 10 weeks during the study. The participant who withdrew from the study before 10 weeks was not included in the calculations.


Eligibility Criteria
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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01302964


Locations
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United States, Indiana
Riley Child and Adolescent Psychiatry Clinic Riley Hospital
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Lurie Center -MassGeneral Hospital
Lexington, Massachusetts, United States, 02421
Sponsors and Collaborators
Massachusetts General Hospital
Autism Speaks
Investigators
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Principal Investigator: Christopher J. McDougle, M.D. Indiana University School of Medicine
  Study Documents (Full-Text)

Documents provided by Christopher John McDougle, M.D., Massachusetts General Hospital:
Study Protocol and Statistical Analysis Plan  [PDF] April 16, 2018

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Christopher John McDougle, M.D., Director, Lurie Center for Autism, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01302964    
Other Study ID Numbers: 2012P001009
First Posted: February 24, 2011    Key Record Dates
Results First Posted: November 7, 2018
Last Update Posted: November 7, 2018
Last Verified: October 2018
Keywords provided by Christopher John McDougle, M.D., Massachusetts General Hospital:
Autistic Disorder
Asperger's Disorder
Pervasive Developmental Disorder
Additional relevant MeSH terms:
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Disease
Autism Spectrum Disorder
Developmental Disabilities
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders
Mirtazapine
Antidepressive Agents
Psychotropic Drugs
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Serotonin 5-HT3 Receptor Antagonists