Clinical trial NCT01302964: Mirtazapine Treatment of Anxiety in Children and Adolescents With Pervasive Developmental Disorders
Official title: Mirtazapine Treatment of Anxiety in Children and Adolescents With Pervasive Developmental Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Autism Spectrum Disorders
Keywords: Autistic Disorder
Asperger's Disorder
Pervasive Developmental Disorder
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Autism Speaks
First posted: 2011-02-24
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Mean 10-Week Change in Pediatric Anxiety Rating Scale 5-Item Total Score, Double-blind Phase
timeFrame: Weeks Baseline, 2, 4, 6, and 10
measure: 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)
timeFrame: Screen (Visit 1) Baseline (Visit 2) and Endpoint (Week 10)
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Riley Child and Adolescent Psychiatry Clinic Riley Hospital
state: Indiana
city: Lexington
country: United States
facility: Lurie Center -MassGeneral Hospital
state: Massachusetts
Study officials:
affiliation: Indiana University School of Medicine
name: Christopher J. McDougle, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.