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Risperidone Treatment In Children With Autism Spectrum Disorder And High Levels Of Repetitive Behavior
NCT01171937 · View on ClinicalTrials.gov ↗
Study Summary
The proposed study attempts to deepen our understanding of repetitive behaviors in autism spectrum disorders (ASD) and its treatment by examining the changes in key neural circuits associated with risperidone treatment using functional MRI. This study is a substudy of a larger center grant (IRB#07-03-066). Other studies also under this center grant, include: IRB#03-02-085, IRB#95-01-028. All participants will have the option to enter another sub-study, should they meet criteria. The proposed study will address this aim by mounting a controlled trial of 52 children with Autism Spectrum Disorder. After screening assessment, children will enter a three-part study. Phase 1 will be an 8-week, double-blind, placebo-controlled flexible dose trial of risperidone. The extension phase is a 16-week open-label maintenance phase for responders to risperidone or placebo. Non-responders to placebo will be invited to enroll in the eight-week open-label study. 48 of the participants will also undergo fMRI at Week 8 while on blinded treatment, as an optional sub-study. The medication will be dispensed in a liquid suspension and the dose will range from 0.5 mg to 4.0mg.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Risperidone
Study Locations (1)
California
- UCLA — Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2008-09 |
| Est. Completion | 2016-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01171937
The ClinicalTrials.gov registry entry for NCT01171937 describes a study currently listed as completed. It is categorized as Phase 2, 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 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Los Angeles, which has 829 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 Autism appearing as the primary indexed condition, and to 2 interventions — of which Placebo 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: NCT01171937 reports 1 study location spanning 1 distinct geographic area — top geographies include California. 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 NCT01171937 about?
NCT01171937 is a clinical study titled "Risperidone Treatment In Children With Autism Spectrum Disorder And High Levels Of Repetitive Behavior". The proposed study attempts to deepen our understanding of repetitive behaviors in autism spectrum disorders (ASD) and its treatment by examining the changes in key neural circuits associated with risperidone treatment using functional MRI. This study is a substudy of a larger center grant (IRB#07-0...
What is the current status of trial NCT01171937?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2008-09. Estimated completion is 2016-12.
What conditions does trial NCT01171937 study?
This clinical trial studies the following conditions: Autism. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01171937?
The interventions under investigation include: Placebo (DRUG), Risperidone (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01171937?
This trial is sponsored by University of California, Los Angeles, which has 829 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01171937 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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