This study is a pilot study to evaluate the feasibility and safety of conducting a year long, double-blind, placebo-controlled trial of fluoxetine in pre-school children to enhance developmental processes in core areas impacted by autism.

Autism, a brain disorder that affects a small percentage of Americans, often results in a lifetime of impaired thinking, feeling, and social functioning. The disorder generally becomes apparent in children by the age of 3. Autism typically affects a person's ability to communicate, form relationships with others, and respond appropriately to the external world. Some people with autism can function at a relatively high level, with speech and intelligence intact. Others have serious cognitive impairments and language delays, and some never speak. This study will assess the safety and effectiveness of treating autistic children with fluoxetine to enhance developmental processes in core areas impacted by autism.

Each participant was randomly assigned to treatment with double-blinded placebo or fluoxetine for 12 months. After initial screening and randomization, participants were assessed every two weeks for approximately the first 3 months, or until the dose of medication is stabilized. After this initial period, they were assessed on a monthly basis. Dosing was flexible as determined by the adverse and beneficial responses to treatment although there was a suggested titration schedule.

Inclusion Criteria:

• Diagnosis of autism

Exclusion Criteria:

• Diagnosis of Asperger Syndrome, Rett Syndrome, Childhood Disintegrative Disorder, or Pervasive Development Disorder-Not Otherwise Specified
• Informed that treatment with a selective serotonin reuptake inhibitor (SSRI) is medically inadvisable
• Need for ongoing psychotropic medication (except for diphenhydramine, clonidine, or melatonin for sleep)
• Recent use of stimulants within 5 days prior to enrollment
• Ongoing need for or recent use of most psychotropic medications within 14 days of enrollment
• Recent initiation of specialized educational, behavioral, or diet intervention for autism in the month prior to enrollment

12 months (The course of treatment for each participant in the trial)

It took twice as long to recruit subjects for a study in children 30-58 months than it generally takes to recruit older children. It is possible to maintain subjects in double-blind trails for extended periods.