Study of Fluoxetine in Autism

Neuropharm158 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

158

Conditions

Autistic Disorder

Interventions

FluoxetineDRUG

Once daily oral dispersible tablet 2mg 9mg or 18mg

PlaceboDRUG

Oral dispersible tablet placebo

Eligibility

Sex: ALLMin age: 5 YearsMax age: 17 Years

Medical Language ↔ Plain English

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.

Locations (17)

Southwest Autism Research and Resource Centre

Phoenix, Arizona, United States

University of California Davis

Sacramento, California, United States