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

This study has been completed.
Forest Laboratories
Information provided by (Responsible Party):
Eric Hollander, Montefiore Medical Center Identifier:
First received: December 27, 2010
Last updated: November 19, 2014
Last verified: November 2014

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.

Condition Intervention Phase
Autism Spectrum Disorder
Asperger Syndrome
Aspergers Syndrome
Drug: Milnacipran
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Milnacipran in Autism and the Functional Locus Coeruleus and Noradrenergic Model of Autism

Resource links provided by NLM:

Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • Change in Score on Conners Adults Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale [ Time Frame: Baseline through Week 12 ]
    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.

Secondary Outcome Measures:
  • Aberrant Behavior Checklist - Irritability Scale [ Time Frame: Screening, baseline, weeks 2,4,6,8,10,12 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    A scale that measures improvement based off of the clinician's interpretations.

Enrollment: 10
Study Start Date: February 2011
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Milnacipran Drug: Milnacipran
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 Drug: Placebo
Subjects will be given placebo tablets at dosing corresponding to the fixed schedule between 12.5mg and 100mg.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male and Female patients
  • Aged 18-50 years
  • Diagnosis of Autism Spectrum Disorder
  • IQ greater than 70

Exclusion Criteria:

  • Pregnant subjects
  • Patients deemed by comprehensive psychiatric interview to have a significant risk of suicide
  Contacts and Locations
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Please refer to this study by its identifier: NCT01337700

United States, New York
Montefiore Medical Center, Albert Einstein College of Medicine
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
Forest Laboratories
Principal Investigator: Eric Hollander, MD Montefiore Medical Center, Albert Einstein College of Medicine
  More Information

Responsible Party: Eric Hollander, Clinical Professor, Montefiore Medical Center Identifier: NCT01337700     History of Changes
Other Study ID Numbers: SAV-MD-21
10-09-299 ( Other Identifier: Montefiore Institutional Review Board )
Study First Received: December 27, 2010
Last Updated: November 19, 2014

Keywords provided by Montefiore Medical Center:
Autism Spectrum Disorder
Asperger Syndrome

Additional relevant MeSH terms:
Asperger Syndrome
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents processed this record on April 26, 2017