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

NCT00655174 | Completed Phase 3 DMC

• 1 other identifier: 0019990290
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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-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.

Conditions

Autism

Keywords

autism; fluvoxamine; sertraline; selective seratonin reuptake inhibitors; paediatrics

Outcome Measures

Primary Outcomes (1)

• The severity of the autistic child's behaviour or condition (assessed by parents)

  At baseline and weekly thereafter until the study is completed

Secondary Outcomes (2)

• Weight and vital signs

  Weeks 1, 7 and 11

• Blood count and liver function studies

  Weeks 1 and 11

Study Arms (3)

1

PLACEBO COMPARATOR

Drug: Placebo

2

EXPERIMENTAL

Drug: fluvoxamine

3

EXPERIMENTAL

Drug: sertraline

Interventions

fluvoxamine DRUG

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.

2

sertraline DRUG

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.

3

Placebo DRUG

Patients in this study arm will receive capsules that appear identical to those of the two study drugs but will contain no active ingredient.

1

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Autistic Disorder

Interventions

Fluvoxamine; Sertraline

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Oximes; Hydroxylamines; Amines; Organic Chemicals; 1-Naphthylamine; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Sunita Vohra, MD

  Stollery Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 4, 2008
• First Posted: April 9, 2008
• Study Start: June 1, 1999
• Primary Completion: September 1, 2006
• Study Completion: January 1, 2007
• Last Updated: April 9, 2008

Record last verified: 2008-04

Locations

CA (1)