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Sponsors and Collaborators: |
Neuropharm Autism Speaks |
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Information provided by: | Neuropharm |
ClinicalTrials.gov Identifier: | NCT00787111 |
This open-label research study will continue to monitor the safety of fluoxetine in children after their completion of a previous double-blind placebo controlled clinical study, with fluoxetine. The study will also look at the effect of fluoxetine on IQ (Intelligence Quotient) over an 18 month period.
Condition | Intervention | Phase |
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Autistic Disorder |
Drug: Fluoxetine (prozac) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Extended Management & Measurement of Autism (Emma): An Open-Label, Follow-On Study to Investigate the Safety and Impact on Developmental Trajectory of 18 Months Treatment With Fluoxetine Orally Dissolving Tablet (Odt) In Childhood and Adolescent Autistic Disorder |
Estimated Enrollment: | 128 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Fluoxetine ODT: Experimental
Fluoxetine ODT ranging from 2mg to 54mg
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Drug: Fluoxetine (prozac)
Formulation: ODT
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This research study will monitor the safety of fluoxetine in all patients after their completion of the previous clinical study, in which they received fluoxetine or placebo. The study will look at the effect of fluoxetine on IQ (Intelligence Quotient) over an 18 month period. A possible total of 128 children and adolescents with AD will participate in the study from sites across the US.
The study is open-label. All of the subjects in this study will receive the active medicine fluoxetine orally dissolving tablets (ODT). Children will begin by receiving a daily dose of 2mg fluoxetine for two weeks. The family and child will be asked to come back to the clinic 2 weeks later and, depending on the child's tolerance and response to the medicine, may have his or her dose increased to 4mg/day. After this visit, the time between visits to the clinic and the dose that the child will receive will be decided by the study investigator based on their clinical judgment on benefit versus tolerability. The largest daily dose of fluoxetine that the child could receive in this study is 54mg.
Ages Eligible for Study: | 5 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |
Southwest Autism Research and Resource Centre | |
Phoenix, Arizona, United States, 85006 | |
United States, California | |
University of California Davis | |
Sacramento, California, United States, 95817 | |
United States, Georgia | |
Institute for Behavioral Medicine | |
Smyrna, Georgia, United States, 30080 | |
United States, Illinois | |
AMR-Baber Research Inc. | |
Naperville, Illinois, United States, 60563 | |
University of Illinois | |
Chicago, Illinois, United States, 60637-1448 | |
United States, Massachusetts | |
Harvard Medical School | |
Medford, Massachusetts, United States, 02155 | |
United States, Michigan | |
Children's Hospital of Michigan | |
Detroit, Michigan, United States, 48201 | |
United States, New Jersey | |
CRCNJ | |
Voorhees, New Jersey, United States, 08043 | |
United States, New York | |
Long Island Jewish Hospital | |
Bethpage, New York, United States, 11714 | |
Mount Sinai School of Medicine | |
New York, New York, United States, 10029 | |
United States, North Carolina | |
University of North Carolina | |
Chapel Hill, North Carolina, United States, 27514 | |
United States, Ohio | |
Ohio State University | |
Columbus, Ohio, United States, 43210 | |
United States, Washington | |
Seattle Children's Hosptial University of Washington | |
Seattle, Washington, United States, 98105-0371 |
Responsible Party: | Neuropharm ( Dr. Mike Snape/ Chief Scientific Officer ) |
Study ID Numbers: | NPL-2008-4-AUTUS-005 |
Study First Received: | November 5, 2008 |
Last Updated: | November 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00787111 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Drug: Fluoxetine |
Developmental Disabilities Neurotransmitter Agents Psychotropic Drugs Serotonin Uptake Inhibitors Serotonin Child Development Disorders, Pervasive Fluoxetine |
Autistic Disorder Mental Disorders Mental Disorders Diagnosed in Childhood Antidepressive Agents, Second-Generation Autism Antidepressive Agents |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Disease Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Serotonin Uptake Inhibitors Pharmacologic Actions Child Development Disorders, Pervasive Fluoxetine |
Pathologic Processes Serotonin Agents Autistic Disorder Mental Disorders Therapeutic Uses Mental Disorders Diagnosed in Childhood Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |