Clinical trial NCT00183339: Early Intervention With Fluoxetine in Autism
Official title: A Randomized, Placebo-controlled Trial of Fluoxetine in Preschool Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Autistic Disorder
Keywords: Autism
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2005-09-16
Enrollment: 18
Sex: ALL
Minimum age (years): 30
Maximum age (years): 58
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of Recruitment
timeFrame: 19 months
Secondary outcomes:
measure: Rate of Attrition
timeFrame: Measured at Month 12
measure: Change From Baseline to 12 Months in Total Score on Caregiver Strain Questionnaire
timeFrame: 12 months
measure: Change From Baseline to Month 12 in Aberrant Behavior Checklist Irritability Subscale Score (ABC-I)
timeFrame: 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina, Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Linmarie Sikich, MD
role: STUDY_CHAIR
References: