Study of Fluoxetine in Adults With Autistic Disorder

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2002 by FDA Office of Orphan Products Development.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00027404
First received: December 5, 2001
Last updated: December 7, 2005
Last verified: November 2002
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Fluoxetine Vs Placebo in Adult Autistic Disorder

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Eric Hollander, MD Mount Sinai School of Medicine New York, New York, United States
  More Information

No publications provided

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

Keywords provided by FDA Office of Orphan Products Development:
Adult, Autism

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Fluoxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014