Antibiotic Treatment Trial for the PANDAS/PANS Phenotype (AZT)
The purpose of this research study is to know if the antibiotic azithromycin, an antibiotic approved by the U.S. Food and Drug Administration (FDA) for treating infections, improves symptom severity in children with sudden and severe onset obsessive compulsive symptoms known as PANS, Pediatric Acute Onset Neuropsychiatric Syndrome, and PANDAS, Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcus. This study seeks to compare the effects of placebo vs. azithromycin on Obsessive Compulsive Disorder (OCD) symptom severity as well as to assess immune risk factors in children with PANDAS/PANS. Obsessions are repetitive, unwanted thoughts or worries that may be unpleasant, silly, or embarrassing. Compulsions are repetitive or ritualistic actions that are performed to ease anxiety or worries. Doctors think these symptoms may be caused or exacerbated by certain infections such as Streptococcus pyogenes, Mycoplasma pneumonia, Borrelia burgordfi, etc. These infections commonly cause strep throat, walking pneumonia, and Lyme Disease, among others.
This study will involve a 4 week double-blind, placebo-controlled randomized trial of azithromycin (Double Blind Phase). At the end of this 4 week trial, the child will be assigned to azithromycin for 8 weeks (Open Label Phase). At the end of these 12 weeks, a Naturalistic Observation phase will assess the child's symptom characteristics for up to 40 weeks.
The study hypothesizes that children receiving antibiotic will show significantly greater overall improvement in severity compared with placebo, and that children with sudden onset of OCD and whose subsequent course shows dramatic fluctuations will have evidence of immune risk factors that predisposes to this presentation.
Obsessive Compulsive Disorder (OCD)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Antibiotic Treatment Trial for the PANDAS/PANS Phenotype|
- Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) [ Time Frame: Every 2 weeks for 12 weeks ] [ Designated as safety issue: No ]
- Clinical Global Impressions [ Time Frame: Every 2 weeks for 12 weeks ] [ Designated as safety issue: No ]
- Screen for Child Anxiety Related Disorders [ Time Frame: Every week for 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||May 2012|
|Study Completion Date:||December 2014|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Azithromycin
Antibiotic used to treat infections.
Antibiotic used to treat infections
Placebo Comparator: Placebo
Compound thickening agent with sugar and flavor additives.
Thickening compound with sugar and flavoring
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01617083
|United States, Florida|
|Rothman Center for Neuropsychiatry|
|Saint Petersburg, Florida, United States, 33701|
|Principal Investigator:||Tanya Murphy, MD||University of South Florida|