Fluoxetine Essay in Children With Autism (FAIR)
This study has been withdrawn prior to enrollment.
(Withdrawn for problem of logistics with the associated laboratories)
Sponsor:
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00873834
First received: April 1, 2009
Last updated: January 9, 2012
Last verified: April 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Autism |
Drug: fluoxetine Drug: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Fluoxetine : Clinical and Anatomy-functional Therapeutic Effects in Children With Autism |
Resource links provided by NLM:
Further study details as provided by Assistance Publique - Hôpitaux de Paris:
Primary Outcome Measures:
- Subscores of Autism Diagnostic Interview (ADI-R)at each visit of the protocol (LECOUTER et RUTTER, 1989) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Sides effect scale (FSEC) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Aberrant Behavior Checklist (Aman et al., 1985) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Clinical Global Impressions (CGI) severity and improvement (NIMH.1985) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 0 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | November 2011 |
| Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Fluoxetine arm
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
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 Other Name: SSRI compared to placebo
|
|
Placebo Comparator: placebo arm
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
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.
Other Name: Placebo and drug packaging applied
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 5 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00873834 History of Changes |
| Other Study ID Numbers: | P030901, AOM 98082 |
| Study First Received: | April 1, 2009 |
| Last Updated: | January 9, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
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) |
Additional relevant MeSH terms:
|
Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Diagnosed in Childhood Mental Disorders Fluoxetine Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013