Mirtazapine Treatment of Anxiety in Children and Adolescents With Pervasive Developmental Disorders
This study will determine the effectiveness of mirtazapine in reducing anxiety in children with autistic disorder, Asperger's disorder and Pervasive Developmental Disorder.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Mirtazapine Treatment of Anxiety in Children and Adolescents With Pervasive Developmental Disorders|
- Pediatric Anxiety Rating Scale (PARS) [ Time Frame: Collected at screen (Visit 1) baseline (Visit 2) and endpoint (Week 10) ] [ Designated as safety issue: No ]Assesses severity across common anxiety disorders in children including generalized anxiety, social anxiety, separation anxiety and transition-associated anxiety.
- Clinical Global Impressions (CGI) [ Time Frame: Screen (Visit 1) Baseline (Visit 2) and Endpoint (Week 10) ] [ Designated as safety issue: No ]The CGI is designed to take into account all factors to arrive at an assessment of severity and response to treatment.
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||August 2014|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
The starting dose for subjects is 7.5 mg daily. The maximum daily dose will be 45 mg.
Subjects will receive 7.5 mg daily at the start of the trial. The dose will be increased by 7.5 mg weekly for subject weighing less than 5 50kg and up to 15 mg weekly for subjects weighing more than 50kg depending upon efficacy and tolerability.
Other Name: GeodonDrug: Mirtazapine
Subjects will receive 7.5 mg of mirtazapine daily initially. The dose will be increased by 7.5 mg for subjects weighing less than 50kg and up to 15 mg per week for subjects weighing more than 50kg. depending upon efficacy and tolerability.
Other Name: Geodon
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.
Subjects randomized to placebo will receive placebo for duration of the study
Other Name: Sugar pill
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01302964
|Contact: Jennifer Mullett, RN,CCRP||781-860-1711||LurieCenterResearch@partners.org|
|United States, Indiana|
|Riley Child and Adolescent Psychiatry Clinic Riley Hospital||Completed|
|Indianapolis, Indiana, United States, 46202|
|United States, Massachusetts|
|Lurie Center -MassGeneral Hospital||Recruiting|
|Lexington, Massachusetts, United States, 02421|
|Contact: Jennifer Mullett, RN,CCRP 781-860-1711 LurieCenterResearch@partners.org|
|Principal Investigator: Christopher J McDougle, MD|
|Principal Investigator:||Christopher J. McDougle, M.D.||Indiana University School of Medicine|