Milnacipran in Autism and the Functional Locus Coeruleus and Noradrenergic Model of Autism
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Psychiatric, Autism |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 10/14/2017 |
| Start Date: | February 2011 |
| End Date: | July 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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
