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

Montefiore Medicine Academic Health System

Status and phase: Completed; Phase 4

Conditions: Aspergers Syndrome; Autism Spectrum Disorder; Asperger Syndrome

Treatments: Drug: Placebo; Drug: Milnacipran

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01337700

10-09-299

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

10 participants in 2 patient groups, including a placebo group

Milnacipran

Experimental group

Treatment:

Drug: Milnacipran

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo