At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of autism
- ✕Diagnosis of Asperger Syndrome, Rett Syndrome, Childhood Disintegrative Disorder, or PDD-NOS
- ✕Medically inadvisable to treat with an SSRI
- ✕Need for ongoing psychotropic medication (except diphenhydramine, clonidine, or melatonin for sleep)
- ✕Recent use of stimulants within 5 days prior to enrollment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Placebo-controlled Trial of Fluoxetine in Preschool Children
In Brief
A Phase 2 clinical trial evaluating Fluoxetine and Placebo for Autistic Disorder. Completed, enrolled 18 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
Between 2 mg per day and 20 mg per day of liquid fluoxetine will be given in the morning using a flexible dosing strategy, following a 36-week dose titration schedule.
Between 0.5ml per day and 5ml per day of liquid placebo will be given in the morning using a flexible dosing strategy, following a 36-week dose titration schedule.