Clinical trial NCT00515320: Study of Fluoxetine in Autism
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Autistic Disorder
Keywords: Autism
children
adolescent
Fluoxetine
Autistic Disorder
Repetitive behavior
SSRI
Selective Serotonin Reuptake Inhibitor
Lead sponsor: Neuropharm
Sponsor class: INDUSTRY
Collaborators: name: Autism Speaks
First posted: 2007-08-13
Enrollment: 158
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The percentage change from baseline to the endpoint visit for the CYBOCS-PDD score.
timeFrame: Throughout the study
Secondary outcomes:
measure: The time and dose related course of therapeutic effects
timeFrame: Throughout the study
measure: The inter-relationship between these effects in the context of global clinical changes.
timeFrame: Throughout the study
measure: The indirect effects on patient caregivers of the dose regime in these subjects compared to placebo during treatment.
timeFrame: Throughout the study
measure: Safety measures will be physical examination, vital signs, EKG/ECG & clinical laboratory tests.
timeFrame: Throughout the study
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Southwest Autism Research and Resource Centre
state: Arizona
city: Sacramento
country: United States
facility: University of California Davis
state: California
city: Gainesville
country: United States
facility: University of Florida, Department of Psychiatry
state: Florida
city: Smyrna
country: United States
facility: Institute for Behavioral Medicine
state: Georgia
city: Chicago
country: United States
facility: University of Illinois
state: Illinois
city: Naperville
country: United States
facility: AMR-Baber Research Inc.
state: Illinois
city: Medford
country: United States
facility: Harvard Medical School
state: Massachusetts
city: Detroit
country: United States
facility: Children's Hospital of Michigan
state: Michigan
city: Las Vegas
country: United States
facility: Center for Psychiatry and Behavioral Medicine
state: Nevada
city: Voorhees
country: United States
facility: CRCNJ
state: New Jersey
city: Bethpage
country: United States
facility: Long Island Jewish Hospital
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Pittsburgh
country: United States
facility: Western Psychiatric Institute and Clinic/ Merck Child Outpatient Clinic
state: Pennsylvania
city: Houston
country: United States
facility: Red Oak Psychiatry Associates
state: Texas
city: Seattle
country: United States
facility: Seattle Children's Hosptial University of Washington
state: Washington
Study officials:
References:
citation: Herscu P, Handen BL, Arnold LE, Snape MF, Bregman JD, Ginsberg L, Hendren R, Kolevzon A, Melmed R, Mintz M, Minshew N, Sikich L, Attalla A, King B, Owley T, Childress A, Chugani H, Frazier J, Cartwright C, Murphy T; Autism Speaks Autism Clinical Trials Network. The SOFIA Study: Negative Multi-center Study of Low Dose Fluoxetine on Repetitive Behaviors in Children and Adolescents with Autistic Disorder. J Autism Dev Disord. 2020 Sep;50(9):3233-3244. doi: 10.1007/s10803-019-04120-y.