Randomized Study of Fluoxetine in Children and Adolescents With Autism

This study has been completed.
Sponsor:
Collaborator:
Mount Sinai School of Medicine
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00004486
First received: October 18, 1999
Last updated: December 7, 2005
Last verified: December 2000
  Purpose

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 Intervention
Autism
Drug: fluoxetine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


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

Estimated Enrollment: 45
Study Start Date: September 1998
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.

  Eligibility

Ages Eligible for Study:   5 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Meets diagnostic criteria for autism

--Prior/Concurrent Therapy--

Other:

  • 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

Cardiovascular:

  • No significant cardiovascular disease
  • No abnormal EKG

Neurological:

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

Other:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004486

Locations
United States, New York
Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Mount Sinai School of Medicine
New York, New York, United States, 10029
New York University Medical Center
New York, New York, United States, 10016
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Study Chair: Eric Hollander Mount Sinai School of Medicine
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00004486     History of Changes
Other Study ID Numbers: 199/14266, MTS-FDR001520, MTS-GCO-96-713
Study First Received: October 18, 1999
Last Updated: December 7, 2005
Health Authority: United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:
autism
neurologic and psychiatric disorders
rare disease

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 April 15, 2014