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Sponsored by: |
The Hospital for Sick Children |
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Information provided by: | The Hospital for Sick Children |
ClinicalTrials.gov Identifier: | NCT00655174 |
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.
Condition | Intervention | Phase |
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Autism |
Drug: fluvoxamine Drug: sertraline Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Double-Blind Placebo-Controlled Randomized Clinical Trial of Fluvoxamine and Sertraline in Childhood Autism - Does SSRI Therapy Improve Behaviour and/or Mood? |
Enrollment: | 108 |
Study Start Date: | June 1999 |
Study Completion Date: | January 2007 |
Primary Completion Date: | September 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator |
Drug: Placebo
Patients in this study arm will receive capsules that appear identical to those of the two study drugs but will contain no active ingredient.
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2: Experimental |
Drug: fluvoxamine
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.
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3: Experimental |
Drug: sertraline
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.
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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.
Ages Eligible for Study: | 3 Years to 10 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Ontario | |
The Hospital for Sick Children | |
Toronto, Ontario, Canada |
Principal Investigator: | Sunita Vohra, MD | Stollery Children's Hospital |
Responsible Party: | The Hospital for Sick Children ( Wendy Roberts/Principal Investigator ) |
Study ID Numbers: | 0019990290 |
Study First Received: | April 4, 2008 |
Last Updated: | April 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00655174 |
Health Authority: | Canada: Ethics Review Committee |
autism fluvoxamine sertraline selective seratonin reuptake inhibitors paediatrics |
Developmental Disabilities Child Development Disorders, Pervasive Fluvoxamine Mental Disorders |
Autistic Disorder Mental Disorders Diagnosed in Childhood Sertraline Serotonin |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Serotonin Uptake Inhibitors |
Pharmacologic Actions Serotonin Agents Therapeutic Uses Anti-Anxiety Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |