Milnacipran in Autism and the Functional Locus Coeruleus and Noradrenergic Model of Autism
Autism Spectrum Disorders (ASD) include Autistic disorder, Asperger's syndrome and Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS). These are developmental disorders beginning prior to three years of age. Recent Centers for Disease Control (CDC) estimates suggest that ASD affects up to 1 in 100 individuals and up to 1 in 50 boys. There are very substantial costs associated with caring for patients with ASD, and ASD has the highest Caregiver Burden Scores of any condition. There are three core symptom domains of ASD, including social deficits, repetitive behaviors and language deficits. Patients can also have associated symptoms of attentional deficits, disruptive behaviors and intellectual disability. There is currently no Food and Drug administration (FDA) approved treatment for the core symptoms of autism, but risperidone and aripiprazole have FDA approval for disruptive behaviors associated with autism.
This is a 12 week randomized double blind placebo controlled trial of Milnacipran in adults with ASD or Aspergers Syndrome. Milnacipran is said to play a role in the activation and normalization of the locus coeruleus-noradrenergic system, of which is hypothesized to play a role in behavior adaptations and performance.
Autism Spectrum 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:||Milnacipran in Autism and the Functional Locus Coeruleus and Noradrenergic Model of Autism|
- Change in Score on Conners Adults Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale [ Time Frame: Baseline through Week 12 ] [ Designated as safety issue: No ]Change will be measured in each subject's score on the Conners from baseline through study end (week 12). It is a clinically expert rating scale used to measure attention dysfunction. It offers good psychometric properties and psychopathological item content focused on inattention, impulsivity and hyperactivity. Change in subjects on placebo, will be compared to those receiving the study drug.
- Aberrant Behavior Checklist - Irritability Scale [ Time Frame: Screening, baseline, weeks 2,4,6,8,10,12 ] [ Designated as safety issue: No ]Rating scale sensitive to changes in disruptive behaviors in autism.
- Yale-Brown Obsessive Compulsive Scale (YBOCS)- Compulsion Subscale [ Time Frame: screening, baseline, weeks, 2,4,6,8,10,12 ] [ Designated as safety issue: No ]Clinical tool used to measure repetitive behaviors in autism trials.
- Diagnostic Analysis of Nonverbal Activity-2 (DANVA-2) [ Time Frame: screening, baseline, weeks 2,4,6,8,10,12 ] [ Designated as safety issue: No ]Tool used to measure social cognition in adults with autism, as related to amygdala function.
- NoGo-Go Task During functional Magnetic Resonance Imaging (fMRI) [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]A neurocognitive task of motor inhibition measured during the fMRI.
- Core Autism Treatment Scale - Severity and Improvement [ Time Frame: screening, baseline, weeks 2, 4, 6, 8, 10, 12 ] [ Designated as safety issue: No ]Tool used to compare pretreatment ratings of severity and post treatment ratings of improvement after the start of therapy.
- Clinical Global Impressions Scale (CGI) [ Time Frame: screening, baseline, weeks 2,4,6,8,10,12 ] [ Designated as safety issue: No ]A scale that measures improvement based off of the clinician's interpretations.
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||July 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Patients will receive a titrated dose of milnacipran increasing to a maximum of 100mg a day over the 12 week study period. Dosing will be based on a fixed schedule that will be monitored using a side effect profile.
Other Name: Savella
|Placebo Comparator: Placebo||
Subjects will be given placebo tablets at dosing corresponding to the fixed schedule between 12.5mg and 100mg.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01337700
|United States, New York|
|Montefiore Medical Center, Albert Einstein College of Medicine|
|Bronx, New York, United States, 10467|
|Principal Investigator:||Eric Hollander, MD||Montefiore Medical Center, Albert Einstein College of Medicine|