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COMPLETED Phase 3

Study of Aripiprazole in the Treatment of Pervasive Developmental Disorders

NCT00870727 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to develop a better tolerated and more effective pharmacologic treatment with individuals with Pervasive Developmental Disorder. This is a double-blind, placebo-controlled study of aripiprazole in the management of the maladaptive behaviors of Pervasive Developmental Disorder. The investigators hypothesize that aripiprazole will be more effective than placebo for reducing aggression, tantrum and self-injurious behavior in children with Pervasive Developmental Disorder.

Interventions

  • DRUG Placebo oral capsule
  • DRUG Aripiprazole oral product

Study Locations (1)

Indiana

  • Riley Hospital for Children, Christian Sarkine Autism Treatment Center — Indianapolis

Trial Details

FieldValue
Enrollment Target 33 participants
Start Date 2009-02
Est. Completion 2015-05
Phase Phase 3

Sponsor

Indiana University

1,026 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00870727

The ClinicalTrials.gov registry entry for NCT00870727 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 1,026 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Pervasive Developmental Disorder appearing as the primary indexed condition, and to 2 interventions — of which Placebo oral capsule is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00870727 reports 1 study location spanning 1 distinct geographic area — top geographies include Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00870727 about?

NCT00870727 is a clinical study titled "Study of Aripiprazole in the Treatment of Pervasive Developmental Disorders". The purpose of this study is to develop a better tolerated and more effective pharmacologic treatment with individuals with Pervasive Developmental Disorder. This is a double-blind, placebo-controlled study of aripiprazole in the management of the maladaptive behaviors of Pervasive Developmental Dis...

What is the current status of trial NCT00870727?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 33 participants. The study started on 2009-02. Estimated completion is 2015-05.

What conditions does trial NCT00870727 study?

This clinical trial studies the following conditions: Pervasive Developmental Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00870727?

The interventions under investigation include: Placebo oral capsule (DRUG), Aripiprazole oral product (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00870727?

This trial is sponsored by Indiana University, which has 1,026 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00870727 being conducted?

This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial