Fluvoxamine and Sertraline in Childhood Autism - Does SSRI Therapy Improve Behaviour and/or Mood?
Condition: Autism
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 3

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.
    

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 males than in females. It is characterized by social and and communicative deficits
      and restricted, repetitive interests and behaviours. Most autistic children are delayed in
      the acquisition of both verbal and non-verbal communication skills and many never develop
      useful language. Three-quarters of autistic children have mild to severe mental retardation
      and a quarter develop seizures during later childhood or adolescence. Its etiology is
      heterogenous and there is no cure. Although behaviour therapy is an important tool in
      management, pharmacotherapy remains a necessity for many children. Current therapy is limited
      to antipsychotic drugs that can carry an unacceptable risk of chronic neurotoxicity (tardive
      dyskinesia) or tricyclic antidepressants that have undesireble cardiovascular effects. This
      study proposes to evaluate the potential benefit of selective seratonin reuptake inhibitors
      (SSRIs) in autism.

      All autistic children whose symptoms are not currently well controlled will be offered entry
      into the trial. Each child will randomized to eight weeks of fluvooxamine, sertraline, or
      placebo. If they do not improve on their initial dose, they may have a dose increase and
      continue in the study for a further eight weeks. Due to the significant amount of within- and
      between- patient variability, multiple baseline evaluations will be completed prior to the
      initiation of drug therapy. Parents may choose to continue therapy that was effective for
      their child; if their child was randomized to placebo, parents may choose to try an SSRI for
      a period of 8 weeks to assess effectiveness.
    

Intervention name(s): fluvoxamine; sertraline; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Children will be started on 12.5 mg. If there is no therapeutic effectivenss observed after eight weeks, then the child may have their dose increased. In this case, the child will be followed for an additional eight weeks.; Children will be started on 12.5 mg. If there is no therapeutic effectivenss observed after eight weeks, then the child may have their dose increased. In this case, the child will be followed for an additional eight weeks.; Patients in this study arm will receive capsules that appear identical to those of the two study drugs but will contain no active ingredient.
Intervention MeSH terms: Fluvoxamine; Sertraline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: autism; fluvoxamine; sertraline; selective seratonin reuptake inhibitors; paediatrics