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Study of Fluoxetine in Adults With Autistic Disorder

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: NCT00027404
Recruitment Status : Completed
First Posted : December 7, 2001
Last Update Posted : March 25, 2015
Information provided by:
FDA Office of Orphan Products Development

Brief Summary:
This is a study to determine the effect of fluoxetine in the treatment of adult autism and on functional ability and behavior associated with autism. Evidence suggests abnormal serotonin function in autism. Fluoxetine is a selective inhibitor of the serotonin transporter.

Condition or disease Intervention/treatment Phase
Autistic Disorder Drug: Fluoxetine Not Applicable

Detailed Description:

Eligible patients will undergo comprehensive evaluation. Informants familiar with the patient will also provide information. Patients will be randomized to receive treatment or placebo. During the 12-week treatment there will be weekly monitoring for the first 4 weeks and biweekly monitoring for the next 8 weeks. The drug dosage will be increased each week as tolerated by the patient. Serum levels of fluoxetine and norfluoxetine will be documented at Week 12.

Completion date provided represents the completion date of the grant per OOPD records

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Study Type : Interventional  (Clinical Trial)
Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Fluoxetine vs Placebo in Adult Autistic Disorder
Study Start Date : September 2001
Study Completion Date : August 2005

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:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Meets DSM-IV and ADI criteria for autistic disorder
  • Patients must use effective contraception
  • Negative pregnancy test
  • Clinical Global Impression-Severity Scale for Autistic Disorder (CGI-AD) score of 4

Exclusion criteria:

  • Pregnant or nursing
  • Prior or concurrent history of mental disorders, including schizophrenia, schizoaffective disorder, organic mental disorders, or bipolar disorders
  • Concurrent depression determined by DSM-IV diagnosis
  • Serious suicidal risk
  • Active seizure disorder within the past 2 years
  • Clinically significant or unstable medical illness, including hematopoietic or cardiovascular disease
  • Any organic or systemic disease
  • Any geographical condition that would preclude study compliance
  • Prior or concurrent gastrointestinal, liver, or kidney disease
  • Any other concurrent condition that interferes with the absorption, distribution, metabolism, or excretion of drugs
  • Prior or concurrent cerebrovascular disease or brain trauma
  • Prior or concurrent clinically significant unstable endocrine disorder, such as hypo- or hyperthyroidism
  • Prior or concurrent malignancy
  • Clinically significant abnormalities on EKG, laboratory tests, or physical exam
  • Requirement for ECT or any other psychotropic medication
  • Inability to tolerate taper from psychoactive medication
  • History of hypersensitivity or severe side effects associated with the use of fluoxitine or other serotonin reuptake inhibitors
  • Treatment with any drug known to have a well-defined potential for toxicity to a major organ within the past 30 days
  • Concurrent terfenadine (Seldane) or astemizole (Hismanal)
  • Prior treatment with fluoxetine of 40 mg/day for 6 weeks
  • Prior electroconvulsive therapy within the past 3 months
  • Prior investigational drug use within the past 30 days
  • Prior Monoamine oxidase inhibitor use within the past 14 days
  • Prior long-acting phenothiazines within the past 6 weeks
  • Prior psychotropic drugs within the past 7 days
  • Prior fluoxetine within the past 6 weeks
  • Requirement for any therapeutic intervention that would confound study evaluation

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): NCT00027404

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United States, New York
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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Principal Investigator: Eric Hollander, MD Mount Sinai School of Medicine New York, New York, United States
Layout table for additonal information Identifier: NCT00027404    
Other Study ID Numbers: FD-R-2026-01
First Posted: December 7, 2001    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: November 2002
Keywords provided by FDA Office of Orphan Products Development:
Adult, Autism
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