Investigational Medication Trial for Children with Autism Spectrum Disorder (ASD) Ages 5-12: Targeting Social Interaction and Communication Skills

Purpose:

This study will evaluate the effects of the investigational medication on symptoms such as social interaction and communication skills in children and adolescents between the ages of 6- 12 with ASD. The investigational medication has been approved by the FDA for an indication other than ASD, however it has not been approved by the FDA for ASD and is therefore investigational for this purpose.

Condition:

Autism Spectrum Disorders

Intervention:

Study evaluating the effects of the investigational medication on social interaction and communication skills

Study Type:

Medication Trial

Study Design:

The study consists of 2-3 screening visits and 6 follow-up visits at the clinic spaced biweekly over a period of 12-weeks. There is also an optional extension phase study after the 12-week trial.Two study psychiatrists will monitor your child’s progress during the course of the study. Children who weigh 44lbs or under will need to complete a preliminary evaluation relating to how the medication is metabolized. The preliminary evaluation will require additional visits to the clinic and multiple blood draws.

In addition to participating in this monitored medication trial, your child will receive the following study-related services at no cost:

· Physical examination by a physician who is an ASD specialist

· Neuropsychology assessment

· Health screening

Enrollment:

On Going

Primary Completion Date:

TBD

Groups:

Subjects will be assigned to groups based on weight.

Assigned Interventions:

Subjects will be assigned randomly in a double blind method.

Ages of Eligibility:

6-12

Gender:

Both male and female

Inclusion Criteria:

Indiviuals ages 6-12 years old (of both genders) with a Diagnosis of Autistic Disorder, Asperger Disorder, or PDD not otherwise specified according to DSM-IV-TR criteria are eligible.

Individuals must also be verbally flutent and use atleast three word phrases.

Other inclusion critera need to be met and can be discussed with the Study Coordinator.

Exclusion Criteria:

For patient safety several medication or medically related exclusion criteria exist, details can be discussed with the Study Coordinator

Contacts:

Linda Spritzer- Research Coordinator

Fay J Lindner Center Research Department

LSpritze@nshs.edu

516-562-3643

Locations:

The Feinstein Institute for Medical Research

North Shore- Long Island Jewish Health System

Manhasset, NY

Sponsors & Collaborators:

Forest Research Institute

Investigators:

Dr. Joel Bregman

Study ID Numbers:

will be provided upon enrollment

You will be reimbursed $ 25 per visit for your time and travel expenses.