Clinical trial NCT01337700: Milnacipran in Autism and the Functional Locus Coeruleus and Noradrenergic Model of Autism
Official title: Milnacipran in Autism and the Functional Locus Coeruleus and Noradrenergic Model of Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Autism Spectrum Disorder
Asperger Syndrome
Aspergers Syndrome
Keywords: ASD
Autism
Autism Spectrum Disorder
Asperger Syndrome
Asperger
PDD
PDD-NOS
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: Forest Laboratories
First posted: 2011-04-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Change in Score on Conners Adults Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale
timeFrame: Baseline and Week 12 scores
measure: Change in Hyperactivity as Measured by Aberrant Behavior Checklist - Hyperactivity Scale
timeFrame: Baseline to Endpoint - 12 weeks
Secondary outcomes:
measure: Change in Autism Severity Levels Based on the Clinical Global Impressions Scale
timeFrame: screening, baseline, weeks 2,4,6,8,10,12
measure: Change in Repetitive Behaviors Using YBOCS-Compulsion and Rigidity Subscale
timeFrame: baseline, weeks 2,4,6,8,10,12
measure: Change in Diagnostic Analysis of Nonverbal Activity-2 ADULT FACIAL EXPRESSIONS: (DANVA2-AF)
timeFrame: baseline, weeks 2,4,6,8,10,12
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center, Albert Einstein College of Medicine
state: New York
Study officials:
affiliation: Montefiore Medical Center/Albert Einstein College of Medicine
name: Eric Hollander, MD
role: PRINCIPAL_INVESTIGATOR
References: