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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2017-10-10

Brief Summary

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

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Detailed Description

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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.

Conditions

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Autism Spectrum Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Mirtazapine

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

Group Type EXPERIMENTAL

Mirtazapine

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Placebo

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

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Sugar pill Remeron

Eligibility Criteria

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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

Minimum Eligible Age

5 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No