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

NCT01302964 | Completed Phase 3 Results DMC

• 1 other identifier: 2012P001009
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Autism Spectrum Disorders

Keywords

Autistic Disorder; Asperger's Disorder; Pervasive Developmental Disorder

Outcome Measures

Primary Outcomes (2)

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

  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.

  Weeks Baseline, 2, 4, 6, and 10

• 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)

  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.

  Screen (Visit 1) Baseline (Visit 2) and Endpoint (Week 10)

Study Arms (2)

Mirtazapine

EXPERIMENTAL

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

Drug: Mirtazapine

Placebo

PLACEBO COMPARATOR

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

Interventions

Placebo DRUG

Subjects randomized to placebo will receive placebo for duration of the study

Also known as: Sugar pill

Placebo

Mirtazapine DRUG

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.

Also known as: Remeron

Mirtazapine

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Autism Speaks: collaborator

Study Sites (2)

Riley Child and Adolescent Psychiatry Clinic Riley Hospital

Indianapolis, Indiana, 46202, United States

Location

Lurie Center -MassGeneral Hospital

Lexington, Massachusetts, 02421, United States

Location

Related Publications (1)

• McDougle CJ, Thom RP, Ravichandran CT, Palumbo ML, Politte LC, Mullett JE, Keary CJ, Erickson CA, Stigler KA, Mathieu-Frasier L, Posey DJ. A randomized double-blind, placebo-controlled pilot trial of mirtazapine for anxiety in children and adolescents with autism spectrum disorder. Neuropsychopharmacology. 2022 May;47(6):1263-1270. doi: 10.1038/s41386-022-01295-4. Epub 2022 Mar 3.

  PMID: 35241779 DERIVED

Related Links

• Lurie Center Research

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder; Asperger Syndrome; Child Development Disorders, Pervasive

Interventions

Sugars; Mirtazapine

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Carbohydrates; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Christopher J. McDougle, MD
• Organization: Massachusetts General Hospital

cmcdougle@mgh.harvard.edu

781-860-1783

Study Officials

• Christopher J. McDougle, M.D.

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Lurie Center for Autism

Study Record Dates

• First Submitted: August 25, 2010
• First Posted: February 24, 2011
• Study Start: August 1, 2010
• Primary Completion: October 10, 2017
• Study Completion: October 10, 2017
• Last Updated: November 7, 2018
• Results First Posted: November 7, 2018

Record last verified: 2018-10

Locations

US (2)