Fluoxetine Essay in Children With Autism - Full Text View

Sponsored by:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00873834

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 II

MedlinePlus related topics: Anatomy Autism

Drug Information available for: Fluoxetine Fluoxetine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Fluoxetine : Clinical and Anatomy-Functional Therapeutic Effects in Children With Autism

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 ]

Estimated Enrollment:	30
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
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 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
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 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.

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00873834

Contacts

Contact: CHABANE Nadia, MD	01.40.03.22.92	nadia.chabane@rdb.aphp.fr
Contact: ZILBOVICIUS Monica, MD	01 69 86 78 90 ext +33	monica.zilbovicius@cea.fr

Locations

France, Ile de France
Hopital Robert DEBRE
PARIS, Ile de France, France, 75019

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

CHABANE Nadia, MD

Assistance Publique - Hôpitaux de Paris (Hopital Robert DEBRE)

More Information

No publications provided

Responsible Party:	Department Clinical Research and Development ( Valérie MILLUL )
Study ID Numbers:	P030901, AOM 98082
Study First Received:	April 1, 2009
Last Updated:	May 6, 2009
ClinicalTrials.gov Identifier:	NCT00873834 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

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)

Study placed in the following topic categories:

Developmental Disabilities
Neurotransmitter Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Serotonin
Child Development Disorders, Pervasive
Fluoxetine

Autistic Disorder
Mental Disorders
Mental Disorders Diagnosed in Childhood
Antidepressive Agents, Second-Generation
Autism
Antidepressive Agents

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Pharmacologic Actions
Child Development Disorders, Pervasive
Fluoxetine

Serotonin Agents
Autistic Disorder
Mental Disorders
Therapeutic Uses
Mental Disorders Diagnosed in Childhood
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on May 07, 2009