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

Autism Clinical Trial

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00655174
• Other study ID #: 0019990290
• Status: Completed
• Phase: Phase 3
• First received: April 4, 2008
• Last updated: April 4, 2008
• Start date: June 1999
• Est. completion date: January 2007

Study information

• Verified date: April 2008
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: January 2007
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 10 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism
• Autistic Disorder

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The severity of the autistic child's behaviour or condition (assessed by parents)		At baseline and weekly thereafter until the study is completed	No
Secondary	Weight and vital signs		Weeks 1, 7 and 11	No
Secondary	Blood count and liver function studies		Weeks 1 and 11	No