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NCT00004486 · ClinicalTrials.gov registry record · NA

Randomized Study of Fluoxetine in Children and Adolescents With Autism

A NA study of Autism, sponsored by Icahn School of Medicine at Mount Sinai.

Completed
Registry status
NA
Development phase
45
Enrollment target
3
Study locations

NCT00004486 is a NA study of Autism that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 45 participants, below the 183-participant average among 104 other Autism trials with a reported enrollment target (75% lower). The trial reports 3 study locations across 1 state.

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The verdict

NCT00004486, a NA study of Autism, has completed, sponsored by Icahn School of Medicine at Mount Sinai.

COMPLETED
Registry status
NA
Development phase
45 participants
Enrollment target
3
Study locations

Study 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 Studied

Interventions

  • DRUG fluoxetine

Study Locations (3)

New York

  • New York University Medical Center - New York
  • Mount Sinai School of Medicine - New York
  • Albert Einstein College of Medicine - The Bronx

Trial Details

FieldValue
Enrollment Target 45 participants
Start Date 1998-09
Est. Completion 2002-12
Phase NA

What the Registry Record Tells You About NCT00004486

The ClinicalTrials.gov registry entry for NCT00004486 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 183-participant average among 104 other Autism trials with a reported enrollment target (75% lower). The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Autism appearing as the primary indexed condition, and to 1 intervention - of which fluoxetine is the first listed.

NCT00004486 reports 3 study locations spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT00004486 about?

NCT00004486 is a clinical study titled "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 base...

What is the current status of trial NCT00004486?

This trial is currently completed. It is a NA study. The enrollment target is 45 participants. The study started on 1998-09. Estimated completion is 2002-12.

What conditions does trial NCT00004486 study?

This clinical trial studies the following conditions: Autism.

What interventions are being tested in trial NCT00004486?

The interventions under investigation include: fluoxetine (DRUG).

Who is sponsoring clinical trial NCT00004486?

This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00004486 being conducted?

This trial has 3 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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