Randomized Study of Fluoxetine in Children and Adolescents With Autism

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.

Study Overview

• Status: Completed
• Conditions: Autism
• Intervention / Treatment: Drug: fluoxetine

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.

Completion date provided represents the completion date of the grant per OOPD records

• Study Type: Interventional
• Enrollment: 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10461
      • Albert Einstein College Of Medicine
    • New York, New York, United States, 10016
      • New York University Medical Center
    • New York, New York, United States, 10029
      • Mount Sinai School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Study Chair: Eric Hollander, Icahn School of Medicine at Mount Sinai

Publications and helpful links

General Publications

• 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. doi: 10.1038/sj.npp.1300627.

Study record dates

Study Major Dates

• Study Start: September 1, 1998
• Study Completion: December 1, 2002

Study Registration Dates

• First Submitted: October 18, 1999
• First Submitted That Met QC Criteria: October 18, 1999
• First Posted (Estimate): October 19, 1999

Study Record Updates

• Last Update Posted (Estimate): March 25, 2015
• Last Update Submitted That Met QC Criteria: March 24, 2015
• Last Verified: December 1, 2000

More Information

Terms related to this study

• Keywords: autism; neurologic and psychiatric disorders; rare disease
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Autistic Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Fluoxetine
• Other Study ID Numbers: 199/14266; MTS-FDR001520; MTS-GCO-96-713