Randomized Study of Fluoxetine in Children and Adolescents With Autism
fluoxetine
Trouble du Spectre de l'Autisme+9
+ Troubles Envahissants du Développement
+ Maladies du système nerveux
Étude thérapeutique
Résumé
Date de début de l'étude : 1 septembre 1998
Date à laquelle le premier participant a commencé l'étude.PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, crossover study. All patients receive oral placebo daily during week 0. Patients are randomized to receive either oral fluoxetine or oral placebo daily on weeks 1-8. Patients then crossover to receive treatment on the other arm during weeks 12-20. Completion date provided represents the completion date of the grant per OOPD records
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.45 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 5 à 17 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Meets diagnostic criteria for autism --Prior/Concurrent Therapy-- Other: At least 3 months since prior electroconvulsive therapy At least 1 month since prior investigational drugs or treatment with any drug known to cause major organ toxicity At least 2 weeks since prior monoamine oxidase inhibitors At least 6 weeks since prior long acting phenothiazines At least 1 week since prior other psychotropic drugs No prior fluoxetine of 20 mg/day for 6 weeks At least 6 weeks since prior fluoxetine No concurrent use of terfenadine (Seldane) or astemizole (Hismanal) No concurrent electroconvulsive therapy or other psychotropic drugs (unless otherwise permitted) Prior participation in another serotonin reuptake inhibitor trial allowed --Patient Characteristics-- Hematopoietic: No significant hematopoietic disease Hepatic: No prior or concurrent liver disease Renal: No prior or concurrent kidney disease Cardiovascular: No significant cardiovascular disease No abnormal EKG Neurological: No prior seizure disorder or high risk development of seizures No prior cerebrovascular disease No prior brain trauma Other: Not pregnant or nursing Negative pregnancy test No unstable major medical illness or systemic disease No moderate or severe mental retardation and motor deficits (IQ less than 50) No family history of bipolar disorder No prior or concurrent other mental disorders (e.g., schizophrenia, schizoaffective, organic, or bipolar disorders) No significant autoaggressive behavior or serious suicidal risk No prior or concurrent gastrointestinal conditions No unstable endocrine disease (e.g., hypo or hyperthyroidism) No prior or concurrent malignancy Must be able to tolerate tapering of psychoactive medication No history of hypersensitivity or severe side effects to fluoxetine or other serotonin reuptake inhibitors No history of severe personality disorder or noncompliance
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 3 sites
New York University Medical Center
New York, United StatesOuvrir New York University Medical Center dans Google MapsMount Sinai School of Medicine
New York, United StatesAlbert Einstein College of Medicine
The Bronx, United States