Status:
COMPLETED
Fluvoxamine and Sertraline in Childhood Autism - Does SSRI Therapy Improve Behaviour and/or Mood?
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Autism
Eligibility:
All Genders
3-10 years
Phase:
PHASE3
Brief 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...
Detailed Description
Autism is a neuropsychiatric disorder diagnosed in early childhood. Approximately 10 Canadian children per 10 000 live births suffer from the disorder, which is three to four times more common in male...
Eligibility Criteria
Inclusion
- diagnosis of autism based on Autism Dignostic Interview -Revised and/or Autism Diagnostic Observation Schedule, depending on which is appropriate for the child's chronological age
- ages 3-10 inclusive
- free of psychoactive medication for at least 3 months prior to entry into the trial
Exclusion
- known contra-indications to SSRIs (i.e. hepatic dysfunction)
- Lactose intolerance
- concurrent psychotropic medications (SSRIs can interact with lithium, tricyclic antidepressants, monoamine oxidase inhibitors, and benzodiazepines)
- taking warfarin (SSRIs can increase levels)
- Inability of parents to give informed consent, travel to the clinic visits, administer study medication, or arrange for completion of rating scales by self/school staff
Key Trial Info
Start Date :
June 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00655174
Start Date
June 1 1999
End Date
January 1 2007
Last Update
April 9 2008
Active Locations (1)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada