Study of Fluoxetine in Autism

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Autistic Disorder

Intervention / Treatment
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* Drug: Fluoxetine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluoxetine<br> | Drug: Fluoxetine<br>* Once daily oral dispersible tablet 2mg 9mg or 18mg<br>* Other names: NPL-2008;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Oral dispersible tablet placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage change from baseline to the endpoint visit for the CYBOCS-PDD score. |  | Throughout the study | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SSRI, Autism, children, adolescent, Fluoxetine, Autistic Disorder, Repetitive behavior, Selective Serotonin Reuptake Inhibitor