Randomized Study of Fluoxetine in Children and Adolescents With Autism
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00004486|
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : March 25, 2015
OBJECTIVES: I. Evaluate the efficacy of fluoxetine on social and language deficits, global severity and compulsive dimensions of children and adolescents with autism.
II. Assess the effectiveness of this treatment regimen on neurocognitive deficits in this patient population.
III. Compare the baseline compulsive severity and treatment outcome in these patients.
|Condition or disease||Intervention/treatment||Phase|
|Autism||Drug: fluoxetine||Not Applicable|
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, crossover study. All patients receive oral placebo daily during week 0.
Patients are randomized to receive either oral fluoxetine or oral placebo daily on weeks 1-8. Patients then crossover to receive treatment on the other arm during weeks 12-20.
Completion date provided represents the completion date of the grant per OOPD records
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||45 participants|
|Intervention Model:||Crossover Assignment|
|Study Start Date :||September 1998|
|Study Completion Date :||December 2002|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004486
|United States, New York|
|Albert Einstein College of Medicine|
|Bronx, New York, United States, 10461|
|New York University Medical Center|
|New York, New York, United States, 10016|
|Mount Sinai School of Medicine|
|New York, New York, United States, 10029|
|Study Chair:||Eric Hollander||Icahn School of Medicine at Mount Sinai|