Trial record 14 of 89 for:    Asperger Syndrome

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01337700
Recruitment Status : Completed
First Posted : April 19, 2011
Last Update Posted : November 20, 2014
Forest Laboratories
Information provided by (Responsible Party):
Eric Hollander, Montefiore Medical Center

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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Asperger Syndrome Aspergers Syndrome Drug: Milnacipran Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Milnacipran in Autism and the Functional Locus Coeruleus and Noradrenergic Model of Autism
Study Start Date : February 2011
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

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 )
First Posted: April 19, 2011    Key Record Dates
Last Update Posted: November 20, 2014
Last Verified: November 2014

Keywords provided by Eric Hollander, 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