Phase 4
N=10
Milnacipran in Autism and the Functional Locus Coeruleus and Noradrenergic Model of Autism
Autism Spectrum Disorder · Asperger Syndrome · Aspergers Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01337700 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Change in Score on Conners Adults Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale — 68.6; 71.8; 53.4; 57 T-score
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Milnacipran (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Montefiore Medical Center
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Score on Conners Adults Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale |
68.6; 71.8; 53.4; 57; 55; 50.8 | — |
| PRIMARY Change in Hyperactivity as Measured by Aberrant Behavior Checklist - Hyperactivity Scale |
-10.4; -4.2 | — |
| SECONDARY Change in Autism Severity Levels Based on the Clinical Global Impressions Scale |
1; 1; 1; 1; 3; 2 | — |
| SECONDARY Change in Repetitive Behaviors Using YBOCS-Compulsion and Rigidity Subscale |
12.2; 12; 10; 12.2; 11.6; 13.2 | — |
| SECONDARY Change in Diagnostic Analysis of Nonverbal Activity-2 ADULT FACIAL EXPRESSIONS: (DANVA2-AF) |
16.5; 18.5; 19.25; 19; 19.6; 19.6 | — |
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
Data sourced from ClinicalTrials.gov (NCT01337700). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.