At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 30 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Mirtazapine 7.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Mirtazapine Treatment of Anxiety in Children and Adolescents With Pervasive Developmental Disorders
In Brief
A Phase 3 clinical trial evaluating Placebo and Mirtazapine for Autism Spectrum Disorders. Completed, enrolled 30 participants across 2 sites.
Detailed Summary
This study will determine the effectiveness of mirtazapine in reducing anxiety in children with autistic disorder, Asperger's disorder and Pervasive Developmental Disorder.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAutism Spectrum Disorders
CountriesUnited States
CollaboratorsAutism Speaks
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2010
First PostedFeb 2011
Primary CompletionOct 2017
TodayJul 2026
First PostedFeb 24, 2011
Enrollment StartAug 1, 2010
Primary CompletionOct 10, 2017
TodayJul 2, 2026
Enrollment to primary: 7.2 yearsPosted 15.4 years ago
Interventions
Placebodrug
Subjects randomized to placebo will receive placebo for duration of the study
Mirtazapinedrug
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.