Phase 2
N=18
Early Intervention With Fluoxetine in Autism
Autistic Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00183339 ↗Enrolled (actual)
18
Serious AEs
5.6%
Results posted
Mar 2014
Primary outcome: Primary: Rate of Recruitment — 2.1; 2.1 months/participant at 1 site
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fluoxetine (Drug); Placebo (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Recruitment |
2.1; 2.1 | — |
| SECONDARY Rate of Attrition |
60; 50 | — |
| SECONDARY Change From Baseline to 12 Months in Total Score on Caregiver Strain Questionnaire |
0.8; -1.86 | — |
| SECONDARY Change From Baseline to Month 12 in Aberrant Behavior Checklist Irritability Subscale Score (ABC-I) |
-0.70; -8.50 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00183339). 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.