drugset / Trial / NCT00655174

Fluvoxamine and Sertraline in Childhood Autism - Does SSRI Therapy Improve Behaviour and/or Mood?

NCT00655174

Phase 3 Completed 108 enrolled The Hospital for Sick Children
RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to determine if fluvoxamine or sertraline reduce the fequency or severity of aggressive behaviour, obsessive symptoms, or anxiety in young children with autism. The within-patient variability in this patient population using standard neuropsychological instruments will also be determined and a predictor model for SSRI responsitivity based on baseline neuropsychological testing will be developed.

Timeline

Start
1999-06
Primary completion
2006-09
Completion
2007-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluvoxamine Unknown 12.5 mg
Subject Sertraline Small molecule 12.5 mg

Indications