SOFIA: Study of Fluoxetine in Autism

Sponsor

Neuropharm (Industry)

Overall Status

Completed

CT.gov ID

NCT00515320

Collaborator

Autism Speaks (Other)

158

Enrollment

Locations

Arms

17.1

Duration (Months)

9.3

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Autistic Disorder	Drug: Fluoxetine Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

158 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Aug 1, 2007

Actual Primary Completion Date :

Jan 1, 2009

Actual Study Completion Date :

Jan 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fluoxetine	Drug: Fluoxetine Once daily oral dispersible tablet 2mg 9mg or 18mg Other Names: NPL-2008
Placebo Comparator: Placebo	Drug: Placebo Oral dispersible tablet placebo

Arm

Intervention/Treatment

Experimental: Fluoxetine

Drug: Fluoxetine

Once daily oral dispersible tablet 2mg 9mg or 18mg

Other Names:

NPL-2008

Placebo Comparator: Placebo

Drug: Placebo

Oral dispersible tablet placebo

Outcome Measures

Primary Outcome Measures

The percentage change from baseline to the endpoint visit for the CYBOCS-PDD score. [Throughout the study]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 17 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Southwest Autism Research and Resource Centre	Phoenix	Arizona	United States	85006
2	University of California Davis	Sacramento	California	United States	95817
3	University of Florida, Department of Psychiatry	Gainesville	Florida	United States	32611
4	Institute for Behavioral Medicine	Smyrna	Georgia	United States	30080
5	University of Illinois	Chicago	Illinois	United States	60637-1448
6	AMR-Baber Research Inc.	Naperville	Illinois	United States	60563
7	Harvard Medical School	Medford	Massachusetts	United States	02155
8	Children's Hospital of Michigan	Detroit	Michigan	United States	48201
9	Center for Psychiatry and Behavioral Medicine	Las Vegas	Nevada	United States	89128
10	CRCNJ	Voorhees	New Jersey	United States	08043
11	Long Island Jewish Hospital	Bethpage	New York	United States	11714
12	Mount Sinai School of Medicine	New York	New York	United States	10029
13	University of North Carolina	Chapel Hill	North Carolina	United States	27514
14	Ohio State University	Columbus	Ohio	United States	43210
15	Western Psychiatric Institute and Clinic/ Merck Child Outpatient Clinic	Pittsburgh	Pennsylvania	United States	15203
16	Red Oak Psychiatry Associates	Houston	Texas	United States	77090
17	Seattle Children's Hosptial University of Washington	Seattle	Washington	United States	98105-0371