Study of Fluoxetine in Adults With Autistic Disorder - Full Text View

Sponsor:	FDA Office of Orphan Products Development
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00027404

Purpose

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	Intervention
Autistic Disorder	Drug: Fluoxetine

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Fluoxetine Vs Placebo in Adult Autistic Disorder

Resource links provided by NLM:

MedlinePlus related topics: Autism

Drug Information available for: Fluoxetine Fluoxetine hydrochloride

U.S. FDA Resources

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment:	48
Study Start Date:	September 2001
Estimated Study Completion Date:	October 2005

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00027404

Locations

United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029

Sponsors and Collaborators

FDA Office of Orphan Products Development

Investigators

Principal Investigator:

Eric Hollander, MD

Mount Sinai School of Medicine New York, New York, United States

More Information

No publications provided

Study ID Numbers:	FD-R-2026-01, FD-R-002026-01
Study First Received:	December 5, 2001
Last Updated:	December 7, 2005
ClinicalTrials.gov Identifier:	NCT00027404 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by FDA Office of Orphan Products Development:

Adult, Autism

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on November 09, 2009