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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. Identifier: NCT00004486
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : March 25, 2015
Information provided by:
FDA Office of Orphan Products Development

Brief Summary:

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

Detailed Description:

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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : September 1998
Study Completion Date : December 2002

Resource links provided by the National Library of Medicine

Drug Information available for: Fluoxetine

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


--Disease Characteristics--

Meets diagnostic criteria for autism

--Prior/Concurrent Therapy--


  • At least 3 months since prior electroconvulsive therapy
  • At least 1 month since prior investigational drugs or treatment with any drug known to cause major organ toxicity
  • At least 2 weeks since prior monoamine oxidase inhibitors
  • At least 6 weeks since prior long acting phenothiazines
  • At least 1 week since prior other psychotropic drugs
  • No prior fluoxetine of 20 mg/day for 6 weeks
  • At least 6 weeks since prior fluoxetine
  • No concurrent use of terfenadine (Seldane) or astemizole (Hismanal)
  • No concurrent electroconvulsive therapy or other psychotropic drugs (unless otherwise permitted)
  • Prior participation in another serotonin reuptake inhibitor trial allowed

--Patient Characteristics--

Hematopoietic: No significant hematopoietic disease

Hepatic: No prior or concurrent liver disease

Renal: No prior or concurrent kidney disease


  • No significant cardiovascular disease
  • No abnormal EKG


  • No prior seizure disorder or high risk development of seizures
  • No prior cerebrovascular disease
  • No prior brain trauma


  • Not pregnant or nursing
  • Negative pregnancy test
  • No unstable major medical illness or systemic disease
  • No moderate or severe mental retardation and motor deficits (IQ less than 50)
  • No family history of bipolar disorder
  • No prior or concurrent other mental disorders (e.g., schizophrenia, schizoaffective, organic, or bipolar disorders)
  • No significant autoaggressive behavior or serious suicidal risk
  • No prior or concurrent gastrointestinal conditions
  • No unstable endocrine disease (e.g., hypo or hyperthyroidism)
  • No prior or concurrent malignancy
  • Must be able to tolerate tapering of psychoactive medication
  • No history of hypersensitivity or severe side effects to fluoxetine or other serotonin reuptake inhibitors
  • No history of severe personality disorder or noncompliance

Information from the National Library of Medicine

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 identifier (NCT number): NCT00004486

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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
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
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Study Chair: Eric Hollander Icahn School of Medicine at Mount Sinai
Publications of Results:
Layout table for additonal information Identifier: NCT00004486    
Other Study ID Numbers: 199/14266
First Posted: October 19, 1999    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: December 2000
Keywords provided by FDA Office of Orphan Products Development:
neurologic and psychiatric disorders
rare disease
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors