Randomized Study of Fluoxetine in Children and Adolescents With Autism

NCT ID: NCT00004486

Last Updated: 2015-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-09-30
• Study Completion Date: 2002-12-31

Brief 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.

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

Conditions

Autism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

fluoxetine

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Principal Investigators

Eric Hollander

Role: STUDY_CHAIR

Icahn School of Medicine at Mount Sinai

Locations

New York University Medical Center

New York, New York, United States

Mount Sinai School of Medicine

New York, New York, United States

Albert Einstein College of Medicine

The Bronx, New York, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 15602505 (View on PubMed)

Iffland M, Livingstone N, Jorgensen M, Hazell P, Gillies D. Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD011769. doi: 10.1002/14651858.CD011769.pub2.

Reference Type: DERIVED

PMID: 37811711 (View on PubMed)

Other Identifiers

MTS-FDR001520

Identifier Type: -

Identifier Source: secondary_id

MTS-GCO-96-713

Identifier Type: -

Identifier Source: secondary_id

199/14266

Identifier Type: -

Identifier Source: org_study_id