EUCTR2008‐003712‐36‐FR.

Study name	Etude de la réponse clinique et neurofonctionnelle à la fluoxétine dans l'autisme infantile
Methods	20‐week parallel trial of fluoxetine versus placebo
Participants	Inclusion criteria: diagnosis of ASD or PDD 5‐13 years of age at baseline IQ ≥ 45 3 Exclusion criteria: neurological conditions current treatment with antipsychotics, benzodiazepines, neuroleptics or thermoregulators history of or an allergy to fluoxetine IQ < 45 Location: France Setting: unclear Target sample size: unclear
Interventions	Intervention (fluoxetine) for 20 weeks, 20 mg/5 mL Comparator (placebo) for 20 weeks, equivalent oral solution of placebo
Outcomes	Primary outcomes: BoC (total score of ABC) Secondary outcomes: unclear Timing of outcome assessments: baseline and 20 weeks
Starting date	Registered November 2008
Contact information	Contact name: not reported Contact details: not reported
Notes	Source of funding: Public Assistance ‐ Hopitaux De Paris (AP‐HP) Conflicts of interest: unclear