Randomized Study of Fluoxetine in Children and Adolescents With Autism
Information source: FDA Office of Orphan Products Development
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Autism
Intervention: fluoxetine (Drug)
Phase: N/A
Status: Completed
Sponsored by: FDA Office of Orphan Products Development Official(s) and/or principal investigator(s):
Eric Hollander, Study Chair, Affiliation: Mount Sinai School of Medicine
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.
Clinical Details
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment
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
Minimum age: 5 Years.
Maximum age: 17 Years.
Gender(s): Both.
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
Locations and Contacts
Albert Einstein College of Medicine, Bronx, New York 10461, United States
Mount Sinai School of Medicine, New York, New York 10029, United States
New York University Medical Center, New York, New York 10016, United States
Additional Information
Starting date: September 1998
Last updated: December 7, 2005
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