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Study of Fluoxetine in Autism (SOFIA)

Primary Purpose

Autistic Disorder

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Fluoxetine
Placebo
Sponsored by
Neuropharm
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autistic Disorder focused on measuring Autism, children, adolescent, Fluoxetine, Autistic Disorder, Repetitive behavior, SSRI, Selective Serotonin Reuptake Inhibitor

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Southwest Autism Research and Resource Centre
  • University of California Davis
  • University of Florida, Department of Psychiatry
  • Institute for Behavioral Medicine
  • University of Illinois
  • AMR-Baber Research Inc.
  • Harvard Medical School
  • Children's Hospital of Michigan
  • Center for Psychiatry and Behavioral Medicine
  • CRCNJ
  • Long Island Jewish Hospital
  • Mount Sinai School of Medicine
  • University of North Carolina
  • Ohio State University
  • Western Psychiatric Institute and Clinic/ Merck Child Outpatient Clinic
  • Red Oak Psychiatry Associates
  • Seattle Children's Hosptial University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fluoxetine

Placebo

Arm Description

Outcomes

Primary Outcome Measures

The percentage change from baseline to the endpoint visit for the CYBOCS-PDD score.

Secondary Outcome Measures

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

Full Information

First Posted
August 10, 2007
Last Updated
April 26, 2012
Sponsor
Neuropharm
Collaborators
Autism Speaks
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1. Study Identification

Unique Protocol Identification Number
NCT00515320
Brief Title
Study of Fluoxetine in Autism
Acronym
SOFIA
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

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neuropharm
Collaborators
Autism Speaks

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autistic Disorder
Keywords
Autism, children, adolescent, Fluoxetine, Autistic Disorder, Repetitive behavior, SSRI, Selective Serotonin Reuptake Inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fluoxetine
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Fluoxetine
Other Intervention Name(s)
NPL-2008
Intervention Description
Once daily oral dispersible tablet 2mg 9mg or 18mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral dispersible tablet placebo
Primary Outcome Measure Information:
Title
The percentage change from baseline to the endpoint visit for the CYBOCS-PDD score.
Time Frame
Throughout the study
Secondary Outcome Measure Information:
Title
The time and dose related course of therapeutic effects
Time Frame
Throughout the study
Title
The inter-relationship between these effects in the context of global clinical changes.
Time Frame
Throughout the study
Title
The indirect effects on patient caregivers of the dose regime in these subjects compared to placebo during treatment.
Time Frame
Throughout the study
Title
Safety measures will be physical examination, vital signs, EKG/ECG & clinical laboratory tests.
Time Frame
Throughout the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Southwest Autism Research and Resource Centre
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
University of California Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of Florida, Department of Psychiatry
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Facility Name
Institute for Behavioral Medicine
City
Smyrna
State/Province
Georgia
ZIP/Postal Code
30080
Country
United States
Facility Name
University of Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1448
Country
United States
Facility Name
AMR-Baber Research Inc.
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60563
Country
United States
Facility Name
Harvard Medical School
City
Medford
State/Province
Massachusetts
ZIP/Postal Code
02155
Country
United States
Facility Name
Children's Hospital of Michigan
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Center for Psychiatry and Behavioral Medicine
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
CRCNJ
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Long Island Jewish Hospital
City
Bethpage
State/Province
New York
ZIP/Postal Code
11714
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Western Psychiatric Institute and Clinic/ Merck Child Outpatient Clinic
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15203
Country
United States
Facility Name
Red Oak Psychiatry Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Seattle Children's Hosptial University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105-0371
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31267292
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.
Results Reference
derived
Links:
URL
http://www.autismspeaks.org
Description
www.autismspeaks.org
URL
http://www.neuropharm.co.uk
Description
www.neuropharm.co.uk

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Study of Fluoxetine in Autism

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