Fluoxetine Essay in Children With Autism

NCT00873834 | Withdrawn Phase 2 DMC

• 2 other identifiers: P030901AOM 98082
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a comparative, double blind, placebo controlled trial of 6-months duration designed to evaluate 1) the effects of fluoxetine in 5 to 12 years old autistic children, 2) the effects of fluoxetine on serotoninergic parameters, 3) cerebral metabolic changes (rCBF measurements with PET) induced by the treatment.

Conditions

Autism

Keywords

autism; fluoxetine; Comparative; double blind; placebo; controlled trial; anatomy-functional imaging; children; DSM-IV-R criteria for autism and CARS score (of 30 or above)

Outcome Measures

Primary Outcomes (1)

• Subscores of Autism Diagnostic Interview (ADI-R)at each visit of the protocol (LECOUTER et RUTTER, 1989)

  6 months

Secondary Outcomes (3)

• Sides effect scale (FSEC)

  6 months

• Aberrant Behavior Checklist (Aman et al., 1985)

  6 months

• Clinical Global Impressions (CGI) severity and improvement (NIMH.1985)

  6 months

Study Arms (2)

Fluoxetine arm

EXPERIMENTAL

Treatment with fluoxetine in an oral solution will be given at 0.25mg/kg day during 2 weeks and at 0.4mg/kg day during 16 weeks. A progressive decreased of dosage on a period of 4 weeks to 0.25mg/kg/day (2 weeks) and 0.10mg/kg/day(2 weeks) will be realized

Drug: fluoxetine

placebo arm

PLACEBO COMPARATOR

Placebo comparator. The packaging of study drug and placebo will be performed according to applicable regulatory requirements in the same packaging. An oral solution will be administrated.

Drug: placebo

Interventions

fluoxetine DRUG

Treatment with fluoxetine in an oral solution will be given at 0.25mg/kg day during 2 weeks and at 0.4mg/kg day during 16 weeks. A progressive decreased of dosage on a period of 4 weeks to 0.25mg/kg/day (2 weeks) and 0.10mg/kg/day(2 weeks) will be realized

Also known as: SSRI compared to placebo

Fluoxetine arm

placebo DRUG

Placebo comparator. The packaging of study drug and placebo will be performed according to applicable regulatory requirements in the same packaging. An oral solution will be administrated.

Also known as: Placebo and drug packaging applied

placebo arm

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male and female subjects with diagnosis of Pervasive developmental disorder (PDD) meeting all criteria listed bellow will be included in the study:
• age 5 to 12 years, outpatients.
• presenting with a primary diagnosis of autism according to DSM- IV-R.
• Autism will be diagnosed with Autism Diagnostic Interview (ADI)
• with a score of 30 or above on the Children Autistic Rating Scale (CARS, SCHOPLER et al., 1980).
• Written informed consent obtained from each patient's parents or legal guardian.

You may not qualify if:

• Subjects presenting with any of the following will not be included in the study:
• Participation in any other studies involving investigational or marketed products within 6 months prior to entry in the study.
• Treatment given for autism within the previous 1 month
• Organic mental disorder or organic brain syndrome (including epilepsy)
• Severe mental retardation (IQ \< 45).
• Specific systemic diseases, including history of significant hematological, endocrine, cardiovascular, renal, gastrointestinal or neurological disease (including more than one episode of childhood febrile convulsion).
• Medical contra-indication to treatment with any antidepressant and specially sertraline
• Previous history of intolerance or hypersensitivity to fluoxetine or to drugs with similar chemical structures
• Currant use of concomitant anticoagulant therapy
• Previous participation in any other clinical trial with the study drug
• Require concomitant therapy with any psychotropic drug or with any drug with a psychotropic component

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Autistic Disorder

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Study Officials

• CHABANE Nadia, MD

  Assistance Publique - Hôpitaux de Paris (Hopital Robert DEBRE)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2009
• First Posted: April 2, 2009
• Study Start: September 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2011
• Last Updated: January 10, 2012

Record last verified: 2009-04