Overview

Milnacipran in Autism and the Functional Locus Coeruleus and Noradrenergic Model of Autism

Status:
Completed

Trial end date:
2014-07-01

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Montefiore Medical Center

Collaborator:

Forest Laboratories

Treatments:

Levomilnacipran
Milnacipran

Criteria

Inclusion Criteria:

- Male and Female patients

- Aged 18-50 years

- Diagnosis of Autism Spectrum Disorder

- intelligence quotient greater than 70

Exclusion Criteria:

- Pregnant subjects

- Patients deemed by comprehensive psychiatric interview to have a significant risk of
suicide