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

NCT ID: NCT01337700

Last Updated: 2020-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2014-07-31

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.

Conditions

Autism Spectrum Disorder; Asperger Syndrome; Aspergers Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Milnacipran

Group Type: EXPERIMENTAL

Milnacipran

Intervention Type: DRUG

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.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Subjects will be given placebo tablets at dosing corresponding to the fixed schedule between 12.5mg and 100mg.

Interventions

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.

Intervention Type: DRUG

Placebo

Subjects will be given placebo tablets at dosing corresponding to the fixed schedule between 12.5mg and 100mg.

Intervention Type: DRUG

Other Intervention Names

Savella

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Forest Laboratories

INDUSTRY

Sponsor Role: collaborator

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Eric Hollander

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eric Hollander, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center/Albert Einstein College of Medicine

Locations

Montefiore Medical Center, Albert Einstein College of Medicine

The Bronx, New York, United States

Countries

United States

Other Identifiers

10-09-299

Identifier Type: -

Identifier Source: org_study_id