Study of Fluoxetine in Autism

Condition(s) targeted: Autistic Disorder

Intervention: Fluoxetine (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Neuropharm

Overall contact:
sofia study, Phone: 1-877-SOFIA91, Email: sofiastudy@arkios.com

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: 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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

Secondary outcome:

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.

Minimum age: 5 Years. Maximum age: 17 Years. Gender(s): Both.

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.

sofia study, Phone: 1-877-SOFIA91, Email: sofiastudy@arkios.com

Southwest Autism Research and Resource Centre, Phoenix, Arizona 85006, United States; Recruiting
Sarah Brautigam, MPH, Phone: 602-218-8196
Raun Melmed, M.D., Principal Investigator

University of California Davis, Sacramento, California 95817, United States; Recruiting
Lisa Wilson, Phone: 916-703-0414
Robert Hendren, M.D., Principal Investigator

Yale University, New Haven, Connecticut 06520-7900, United States; Not yet recruiting
Erin Kustan, Phone: 203-785-2508
Lawrence Scahill, MSN/PhD, Principal Investigator

University of Florida, Department of Psychiatry, Gainesville, Florida 32611, United States; Active, not recruiting

Institute for Behavioral Medicine, Smyrna, Georgia 30080, United States; Recruiting
Diana Strommen, Phone: 770-319-8013
Ashraf Attalla, M.D., Principal Investigator

University of Illinois, Chicago, Illinois 60637-1448, United States; Recruiting
Clare Tessman, Phone: 312-996-6746
Thomas Owley, M.D., Principal Investigator

AMR-Baber Research Inc., Naperville, Illinois 60563, United States; Recruiting
Fauzia Manzoor, MD, Phone: 630-844-2095, Email: fmanzoor@americanmedicalresearch.com
Riaz Baber, MD, Principal Investigator

Harvard Medical School, Medford, Massachusetts 02155, United States; Recruiting
Andrea Yee, Phone: 781-306-8635
Jean Frazier, M.D., Principal Investigator

Children's Hospital of Michigan, Detroit, Michigan 48201, United States; Recruiting
Jamie Katusin, Phone: 313-745-0148
Harry Chugani, M.D., Principal Investigator

Center for Psychiatry and Behavioral Medicine, Las Vegas, Nevada 89128, United States; Recruiting
David Menard, Phone: 702-838-0742
Ann Childress, M.D., Principal Investigator

CRCNJ, Voorhees, New Jersey 08043, United States; Recruiting
Catherine Smith, Phone: 856-346-1806, Ext: 106, Email: csmith@thecnnh.org
Mark Mintz, MD, Principal Investigator

Mount Sinai School of Medicine, New York, New York 10029, United States; Recruiting
Natasha Ludwig, Phone: 212-241-2826
Alexander Kolevzon, M.D., Principal Investigator

Long Island Jewish Hospital, Bethpage, New York 11714, United States; Recruiting
Linda Spritzer, Phone: 516-802-8608
Joel Bregman, M.D., Principal Investigator

University of North Carolina, Chapel Hill, North Carolina 27514, United States; Recruiting
Cheryl Alderman, Phone: 919-966-3699
Lin Sikich, M.D., Principal Investigator

Ohio State University, Columbus, Ohio 43210, United States; Recruiting
Lauren Pinto, Phone: 614-688-3848
Eugene Arnold, M.D., Principal Investigator

Western Psychiatric Institute and Clinic/ Merck Child Outpatient Clinic, Pittsburgh, Pennsylvania 15203, United States; Recruiting
Sarah McAuliffe-Bellin, Phone: 412-235-5447
Nancy Minshew, M.D., Principal Investigator

Red Oak Psychiatry Associates, Houston, Texas 77090, United States; Recruiting
Sue Goldsby, Phone: 281-893-4111, Ext: 258
Lawrence Ginsberg, M.D., Principal Investigator

Seattle Children's Hosptial University of Washington, Seattle, Washington 98105-0371, United States; Recruiting
Christopher Budech, Phone: 206-987-3399
Bryan King, M.D., PhD, Principal Investigator

www.cureautismnow.org

www.autismspeaks.org

www.neuropharm.co.uk

Starting date: August 2007
Last updated: July 7, 2008