Randomized Study of Fluoxetine in Children and Adolescents With Autism

NCT00004486 | Completed

• 3 other identifiers: 199/14266MTS-FDR001520MTS-GCO-96-713
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 3

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.

Conditions

Autism

Keywords

autism; neurologic and psychiatric disorders; rare disease

Interventions

fluoxetine DRUG

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (3)

New York University Medical Center

New York, New York, 10016, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

Related Publications (2)

• 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.

  PMID: 15602505 RESULT

• 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.

  PMID: 37811711 DERIVED

MeSH Terms

Conditions

Autistic Disorder; Neurologic Manifestations; Mental Disorders; Rare Diseases

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Study Officials

• Eric Hollander

  Icahn School of Medicine at Mount Sinai

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 18, 1999
• First Posted: October 19, 1999
• Study Start: September 1, 1998
• Study Completion: December 1, 2002
• Last Updated: March 25, 2015

Record last verified: 2000-12

Locations

US (3)