Randomized Study of Fluoxetine in Children and Adolescents With Autism

Autism Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004486
• Other study ID #: 199/14266
• Secondary ID: MTS-FDR001520MTS
• Status: Completed
• Phase: N/A
• First received: October 18, 1999
• Last updated: March 24, 2015
• Start date: September 1998
• Est. completion date: December 2002

Study information

• Verified date: December 2000
• Source: FDA Office of Orphan Products Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 17 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism

Intervention

Drug:
• fluoxetine

Locations

Country	Name	City	State
United States	Albert Einstein College of Medicine	Bronx	New York
United States	Mount Sinai School of Medicine	New York	New York
United States	New York University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation