Randomized Study of Fluoxetine in Children and Adolescents With Autism

Mount Sinai Health System

Status

Completed

Conditions

Autism

Treatments

Drug: fluoxetine

Study type

Interventional

Funder types

Other

Identifiers

NCT00004486

199/14266

MTS-GCO-96-713

MTS-FDR001520

Details and patient eligibility

About

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.

Full 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

Sex

All

Ages

5 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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