Study of fluoxetine in autism: a randomised, double-blind, placebo-controlled, parallel-group 14-week study to investigate the effect of fluoxetine orally dissolving tablet (ODT) on repetitive behaviors in childhood and adolescent autistic spectrum disorder.

Trial Profile

Study of fluoxetine in autism: a randomised, double-blind, placebo-controlled, parallel-group 14-week study to investigate the effect of fluoxetine orally dissolving tablet (ODT) on repetitive behaviors in childhood and adolescent autistic spectrum disorder.

Completed
Phase of Trial: Phase III

Latest Information Update: 26 Apr 2012

At a glance

  • Drugs Fluoxetine (Primary)
  • Indications Autistic disorder; Pervasive child development disorders
  • Focus Therapeutic Use
  • Acronyms SOFIA
  • Most Recent Events

    • 23 Feb 2009 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 18 Feb 2009 Primary endpoint 'Children's Yale Brown Obsessive Compulsive Scale' has not been met; interim results reported in a Neuropharm media release.
    • 11 Sep 2008 Status changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov.
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