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Randomized Study of Fluoxetine in Children and Adolescents With Autism

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

October 18, 1999
December 7, 2005
September 1998
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Complete list of historical versions of study NCT00004486 on Archive Site
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Randomized Study of Fluoxetine in Children and Adolescents With Autism
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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.

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.

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Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Drug: fluoxetine
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Hollander E, Phillips A, Chaplin W, Zagursky K, Novotny S, Wasserman S, Iyengar R. A placebo controlled crossover trial of liquid fluoxetine on repetitive behaviors in childhood and adolescent autism. Neuropsychopharmacology. 2005 Mar;30(3):582-9.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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--Disease Characteristics--

Meets diagnostic criteria for autism

--Prior/Concurrent Therapy--


  • 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


  • No significant cardiovascular disease
  • No abnormal EKG


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


  • 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
5 Years to 17 Years
Contact information is only displayed when the study is recruiting subjects
United States
199/14266, MTS-FDR001520, MTS-GCO-96-713
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FDA Office of Orphan Products Development
Mount Sinai School of Medicine
Study Chair: Eric Hollander Mount Sinai School of Medicine
FDA Office of Orphan Products Development
December 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP