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MENTIS Personal Health Record Rapid Pilot Research Deployment and Evaluation
NCT02090491 · View on ClinicalTrials.gov ↗
Study Summary
Autism Spectrum Disorder (ASD) is a collection of complex neurodevelopmental disorders characterized by qualitative impairments in socialization, communication, and circumscribed interests, including stereotypical behavior patterns and behavioral rigidity to changes in routines (American Psychiatric Association, 1994). ASD is the fastest growing pervasive developmental disorder of childhood, currently estimated to affect 1 in 88 school age children (Baio, 2012). ASD typically manifests in infancy and persist throughout the lifespan. There is no known cause or cure for ASD, yet structured behavioral interventions and medications can enhance developmental outcomes. ASD has a profound impact on families and often result in enormous emotional and financial costs. Recent estimates suggest that societal costs in the US to care for all individuals diagnosed each year over their lifetime approaches $35 billion (Ganz, 2007). Janssen Research \& Development is building a comprehensive digital platform (MENTIS) to optimize and enhance development of novel medicines and track outcomes in individuals with ASD. The MENTIS platform contains several core components, including: (1) An electronic personal healthcare record, designed specifically for individuals with ASD and their caregivers (parents, teachers, healthcare providers); (2) Integrated physiological and physical activity biosensors designed to objectively assess outcomes important in ASD, and; (3) A de-identified research data warehouse with analytic tools to better measure outcomes, assist with sub-population identification, and identify algorithms for diagnosis and treatment response detection. The MENTIS platform is currently being designed, developed, and prepared for testing. During this process it is highly desirable to conduct feasibility and usability research with a sample of the target population to identify important system components and features, optimize design, and reduce redundancy in software developmen
Conditions Studied
Study Locations (1)
New York
- Center for Discovery — Harris
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2013-11 |
| Est. Completion | 2014-10 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02090491
The ClinicalTrials.gov registry entry for NCT02090491 describes a study currently listed as completed. It is categorized as an unspecified phase, 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 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northeastern University, which has 108 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 0 interventions. 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: NCT02090491 reports 1 study location spanning 1 distinct geographic area — top geographies include New York. 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 NCT02090491 about?
NCT02090491 is a clinical study titled "MENTIS Personal Health Record Rapid Pilot Research Deployment and Evaluation". Autism Spectrum Disorder (ASD) is a collection of complex neurodevelopmental disorders characterized by qualitative impairments in socialization, communication, and circumscribed interests, including stereotypical behavior patterns and behavioral rigidity to changes in routines (American Psychiatric...
What is the current status of trial NCT02090491?
This trial is currently completed. The enrollment target is 20 participants. The study started on 2013-11. Estimated completion is 2014-10.
What conditions does trial NCT02090491 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.
Who is sponsoring clinical trial NCT02090491?
This trial is sponsored by Northeastern University, which has 108 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02090491 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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