Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Fluoxetine
• Drug: Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Fluoxetine
• Placebo Comparator: Placebo

Primary Measures

• The percentage change from baseline to the endpoint visit for the CYBOCS-PDD score.
  • Time Frame: Throughout the study
    

Secondary Measures

• The time and dose related course of therapeutic effects
  • Time Frame: Throughout the study
    
• The inter-relationship between these effects in the context of global clinical changes.
  • Time Frame: Throughout the study
    
• The indirect effects on patient caregivers of the dose regime in these subjects compared to placebo during treatment.
  • Time Frame: Throughout the study
    
• Safety measures will be physical examination, vital signs, EKG/ECG & clinical laboratory tests.
  • Time Frame: Throughout the study
    

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 5 Years

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Neuropharm

Overall Clinical Trial Officials and Contacts

Overall Contact: sofia study 1-877-SOFIA91 sofiastudy@arkios.com

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00515320

Study ID Number: NPL-2008-4-AUTUS-004

ClinicalTrials.gov Identifier: NCT00515320

Health Authority: United States: Food and Drug Administration

www.cureautismnow.org

www.autismspeaks.org

www.neuropharm.co.uk