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RUPP PI PDD: Drug and Behavioral Therapy for Children With Pervasive Developmental Disorders
NCT00080145 · View on ClinicalTrials.gov ↗
Study Summary
This 24-week study will compare the safety and effectiveness of medication treatment alone (risperidone or aripiprazole) to medication treatment in combination with a parent management training program.
Conditions Studied
Interventions
- DRUG Risperidone
- BEHAVIORAL Behavior Therapy
Study Locations (3)
Connecticut
- Yale University — New Haven
Indiana
- Indiana University — Indianapolis
Ohio
- Ohio State University — Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2004-02 |
| Est. Completion | 2007-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00080145
The ClinicalTrials.gov registry entry for NCT00080145 describes a study currently listed as completed. It is categorized as NA, 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 124 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,283 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 Child Development Disorders, Pervasive appearing as the primary indexed condition, and to 2 interventions — of which Risperidone 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: NCT00080145 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Connecticut, Indiana, Ohio. 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 NCT00080145 about?
NCT00080145 is a clinical study titled "RUPP PI PDD: Drug and Behavioral Therapy for Children With Pervasive Developmental Disorders". This 24-week study will compare the safety and effectiveness of medication treatment alone (risperidone or aripiprazole) to medication treatment in combination with a parent management training program.
What is the current status of trial NCT00080145?
This trial is currently completed. It is a NA study. The enrollment target is 124 participants. The study started on 2004-02. Estimated completion is 2007-09.
What conditions does trial NCT00080145 study?
This clinical trial studies the following conditions: Child Development Disorders, Pervasive. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00080145?
The interventions under investigation include: Risperidone (DRUG), Behavior Therapy (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00080145?
This trial is sponsored by Yale University, which has 1,283 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00080145 being conducted?
This trial has 3 study locations across Connecticut, Indiana, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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