Trial record 6 of 474 for:    autism

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

This study is currently recruiting participants.
Verified May 2013 by Montefiore Medical Center
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Eric Hollander, Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT01337700
First received: December 27, 2010
Last updated: May 30, 2013
Last verified: May 2013
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    A scale that measures improvement based off of the clinician's interpretations.


Estimated Enrollment: 34
Study Start Date: February 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01337700

Contacts
Contact: Casara J Ferretti, MS 718-696-3036 cferrett@montefiore.org
Contact: Emma Racine, BA 718-653-4859 ext 223 eracine@montefiore.org

Locations
United States, New York
Montefiore Medical Center, Albert Einstein College of Medicine Recruiting
Bronx, New York, United States, 10467
Contact: Casara J Ferretti, MS    718-696-3036    cferrett@montefiore.org   
Principal Investigator: Eric Hollander, MD         
Sponsors and Collaborators
Montefiore Medical Center
Forest Laboratories
Investigators
Principal Investigator: Eric Hollander, MD Montefiore Medical Center, Albert Einstein College of Medicine
  More Information

No publications provided

Responsible Party: Eric Hollander, Clinical Professor, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT01337700     History of Changes
Other Study ID Numbers: SAV-MD-21, 10-09-299
Study First Received: December 27, 2010
Last Updated: May 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Montefiore Medical Center:
ASD
Autism
Autism Spectrum Disorder
Asperger Syndrome
Asperger
PDD
PDD-NOS

Additional relevant MeSH terms:
Autistic Disorder
Asperger Syndrome
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Milnacipran
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents

ClinicalTrials.gov processed this record on April 23, 2014