Study of Fluoxetine in Autism - Tabular View

Tracking Information
First Received Date ^ICMJE	August 10, 2007
Last Updated Date	February 23, 2009
Start Date ^ICMJE	August 2007
Primary Completion Date	January 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 10, 2007)	The percentage change from baseline to the endpoint visit for the CYBOCS-PDD score. [ Time Frame: Throughout the study ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00515320 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 10, 2007)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Study of Fluoxetine in Autism
Official Title ^ICMJE	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.
Brief Summary	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.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Autistic Disorder
Intervention ^ICMJE	Drug: Fluoxetine Drug: Placebo
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	158
Completion Date	January 2009
Primary Completion Date	January 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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	Both
Ages	5 Years to 17 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00515320
Responsible Party	Dr Michael Snape / Chief Scientific Officer, Neuropharm
Study ID Numbers ^ICMJE	NPL-2008-4-AUTUS-004
Study Sponsor ^ICMJE	Neuropharm
Collaborators ^ICMJE	Autism Speaks
Investigators ^ICMJE
Information Provided By	Neuropharm
Verification Date	February 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP