Study of Fluoxetine in Autism

Status:	Completed
Conditions:	Neurology, Psychiatric
Therapuetic Areas:	Neurology, Psychiatry / Psychology
Healthy:	No
Age Range:	5 - 17
Updated:	10/14/2017
Start Date:	August 2007
End Date:	January 2009

Study Of Fluoxetine In Autism: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group 14-Week Study To Investigate The Effect Of Fluoxetine Orally Dissolving Tablet (ODT) On Repetitive Behaviors In Childhood And Adolescent Autistic Disorder.

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.

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.

We found this trial at

sites

Western Psychiatric Institute and Clinic/ Merck Child Outpatient Clinic

3811 O'Hara Street
Pittsburgh, Pennsylvania 15203

from

Pittsburgh, PA