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NCT00468130 · ClinicalTrials.gov registry record · NA

Efficacy of Aripiprazole Versus Placebo in the Reduction of Aggressive and Aberrant Behavior in Autistic Children

A NA study, sponsored by University of Medicine and Dentistry of New Jersey.

Completed
Registry status
NA
Development phase
13
Enrollment target

NCT00468130: Completed NA study, sponsored by University of Medicine and Dentistry of New Jersey.

NCT00468130 is a NA study that has completed, run by University of Medicine and Dentistry of New Jersey. The registered enrollment target is 13 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00468130, a NA study, has completed, sponsored by University of Medicine and Dentistry of New Jersey.

COMPLETED
Registry status
NA
Development phase
13 participants
Enrollment target

Study Summary

Hypothesis: (1) Aripiprazole treatment will be superior to placebo in reducing aggression and irritability in autistic individuals as shown by reductions in the Aberrant Behavior Checklist-irritability subscale. (2) Aripiprazole treatment will be superior to placebo in the acute treatment of global autism severity. The purpose of this study is to examine the possible benefit of the medication Aripiprazole in autistic individuals.

Primary Outcome

Clinical Global Impression Improvement (CGI)-AD (Guy, 1976). This is a standard rating scale with 7-point global severity and change scales which has been modified for Autistic Disorder. A rating of 2 is given when there is a substantial reduction in symptoms so that a treating clinician would be unlikely to change treatment. A rating of 1 is reserved for patients who become virtually symptom-free. A rating of 3 (minimally improved) on the CGI is defined as slight symptomatic improvement that is

Interventions

  • DRUG Placebos
  • DRUG Aripiprazole

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2006-05
Est. Completion 2009-11
Phase NA

What the finished NCT00468130 record still lists

NCT00468130 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebos is the first listed.

NCT00468130 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00468130 about?

NCT00468130 is a clinical study titled "Efficacy of Aripiprazole Versus Placebo in the Reduction of Aggressive and Aberrant Behavior in Autistic Children". Hypothesis: (1) Aripiprazole treatment will be superior to placebo in reducing aggression and irritability in autistic individuals as shown by reductions in the Aberrant Behavior Checklist-irritability subscale. (2) Aripiprazole treatment will be superior to placebo in the acute treatment of global...

What is the current status of trial NCT00468130?

This trial is currently completed. It is a NA study. The enrollment target is 13 participants. The study started on 2006-05. Estimated completion is 2009-11.

What interventions are being tested in trial NCT00468130?

The interventions under investigation include: Placebos (DRUG), Aripiprazole (DRUG).

Who is sponsoring clinical trial NCT00468130?

This trial is sponsored by University of Medicine and Dentistry of New Jersey, which has 88 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00468130's enrollment target sits among peer trials

13 1911th of 2000 higher than 88 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00468130, the US trial registry maintained by the National Library of Medicine. NCT00468130 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.