Study of Fluoxetine in Autism (SOFIA)

Neuropharm

Status and phase

Completed

Phase 3

Conditions

Autistic Disorder

Treatments

Drug: Placebo

Drug: Fluoxetine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00515320

NPL-2008-4-AUTUS-004

Details and patient eligibility

About

The purpose of this study is to assess the effect of fluoxetine orally dissolving tablets (ODT) on the repetitive behaviors core domain in children and adolescents with Autistic Disorder. The study will also investigate the effect of fluoxetine on the improvement of symptoms and the effects on daily living of the patient's family.

Enrollment

158 patients

Sex

All

Ages

5 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Meets DSM-IV criteria for autistic disorder, .
CYBOCS-PDD score of at least 10 at screening.

Exclusion criteria

Diagnosis of Asperger Syndrome or Pervasive Developmental Disorder Not Otherwise Specified, Rett Syndrome, Childhood Disintegrative Disorder.
Patients planning to commence cognitive behaviour therapy during the period of the study or those who have begun cognitive behaviour therapy within 8 weeks prior to enrolment.
Patients who are currently taking fluoxetine or who have previously taken it are not eligible for the study.

Other protocol-defined Inclusion/Exclusion criteria may apply.