Neuropsychiatric test reports
Inventors
Assignees
Publication Number
US-8706526-B2
Publication Date
2014-04-22
Expiration Date
2031-11-07
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Abstract
Methods and reports for presenting genetic information that is patient-specific and relevant to treatment of neuropsychiatric disorders, including treatment resistant psychiatric disorders, to aid in patient treatment in a phenotype, genotype or biomarker-specific manner. The methods and reports examine biomarkers for dysfunction of three axes relevant to treating neuropsychiatric disorders and provide interpretive comments to aid in treatment. Combining biomarker information from each of the three axes (the autonomic arousal axis, the emotional valence, attention, reward and executive brain function axis, and the long-term potentiation and long-term depression (LTP-LTD) function axis) provides an unexpectedly comprehensive and effective means for directing treatment of neuropsychiatric disorders, including particularly treatment resistant disorders (TRD).
Core Innovation
This invention provides methods, systems, and reports for presenting patient-specific genetic and biomarker information that is relevant to the treatment of neuropsychiatric disorders, especially treatment resistant psychiatric disorders such as depression, bipolar disorder, schizophrenia, anxiety disorders, PTSD, autism, and ADHD. The invention utilizes a novel biomarker diagnostic system that integrates information from multiple neurologically relevant functional axes of the brain, rather than relying on categorical diagnostic methods. This dimensional approach examines at least one biomarker from each of three core axes: the autonomic arousal axis, the emotional valence, attention, reward and executive brain function axis, and the long-term potentiation and long-term depression (LTP-LTD) function axis. Some variations also include a fourth pharmacokinetic metabolic axis. Biomarkers within these axes include genetic polymorphisms, epigenetic markers like methylation, transcriptomic data, proteomic markers, and brain imaging data.
The system generates interpretive reports that present the patient-specific biomarker test results along with interpretive analysis, including clinical relevance, associations with disorders, predicted neurotherapeutic responses, and weighted confidence indices based on published studies. The reports may include visual representations of implicated brain regions and provide recommendations for therapeutic interventions tailored to the patient's specific biomarker profile. This method represents a significant shift from traditional psychiatry's categorical diagnoses toward personalized, biologically informed dimensional assessments that aim to rationalize and improve treatment of neuropsychiatric disorders, including those resistant to conventional therapies.
The problem addressed by this invention arises from the high rate of treatment resistance in neuropsychiatric disorders, which is partly due to the imprecise and overlapping nature of current diagnostic categories, lack of effective biomarker-guided diagnostics, and the difficulty clinicians face in interpreting vast amounts of genetic and molecular data for treatment guidance. Prior psychiatric classification systems do not adequately capture the dimensional nature of mental disorders or their neurobiological underpinnings. Existing genetic or biomarker data are often overwhelming and not meaningfully integrated to aid in clinical decision making. There is a critical need for a system that consolidates relevant biomarker information into a concise, interpretable format that aids clinicians in diagnosis and personalized therapy selection, thereby improving treatment outcomes and reducing delays in effective care.
Claims Coverage
The patent includes independent claims directed to computer-implemented methods of generating neuropsychiatric reports based on biomarker test results across multiple neurological axes.
Integration of biomarker test results across three core neuropsychiatric functional axes
Collecting patient-specific biomarker test results for at least one biomarker each in: (1) the limbic mediated autonomic arousal system (e.g., SLC6A4 gene), (2) the prefrontal-subcortical emotional valence, attention, reward and executive brain systems (e.g., COMT, DRD2 genes), and (3) the synaptic mediated long-term potentiation and long-term depression (LTP-LTD) system (e.g., CACNA1C, ANK3 genes).
Generation and presentation of a patient-specific interpretive neuropsychiatric report
Selecting interpretive comments based on the specific biomarker test results, organizing these results and comments into a report comprising an interpretive analysis that describes associations with disorders or brain dysfunction and presenting this report to the clinician or patient.
Therapeutic recommendation selection based on biomarker test results
Providing treatment recommendations tailored to the biomarker results, including recommendations such as agents to downregulate excessive limbic activity when the patient has the short allele of SLC6A4, calcium or sodium channel modulators for CACNA1C or sodium channel gene polymorphisms, S-adenosyl methionine for COMT met/met polymorphisms, dorsal lateral prefrontal cortex stimulation for COMT val/val polymorphisms, and folic acid for MTHFR polymorphisms.
Inclusion of a fourth pharmacokinetic biomarker axis
Collecting biomarker test results specific to pharmacokinetic genes involved in drug absorption, distribution, metabolism or elimination, enabling integration of drug metabolism information into the report and interpretive recommendations.
Incorporation of additional biomarkers in each axis
Collecting additional biomarker data for genes such as ACE, NPY, FKBP5, and HTR1A in the autonomic arousal axis; SLC6A3 in the emotional valence axis; and SLC1A1, BDNF, APOE in the LTP-LTD axis.
Providing visual representation and referral options
Including visual depictions of brain regions associated with biomarker dysfunction and providing referrals to call centers for additional expert interpretation and support.
Digital presentation of the report
Presenting the neuropsychiatric report in electronic form for ease of access and interaction.
The independent claims cover a computer-implemented method for generating comprehensive, patient-specific neuropsychiatric reports by collecting biomarker data across multiple defined neurological axes, selecting interpretive comments and treatment recommendations based on the data, organizing this information into a structured report including confidence indices and brain visualizations, and presenting the report digitally for clinical decision support.
Stated Advantages
Provides a clear and effective means of presenting patient-specific genetic and biomarker information relevant to neuropsychiatric disorder treatment.
Enhances patient care by simplifying interpretation of complex biomarker data and guiding personalized treatment decisions.
Employs a dimensional rather than categorical diagnostic model, improving specificity and therapeutic outcomes for treatment resistant neuropsychiatric disorders.
Integrates data from multiple biomarkers across three or four neurological functional axes to provide a comprehensive neurobiological profile.
Includes interpretive comments with confidence indexing to help clinicians evaluate the strength of supporting scientific evidence.
Facilitates identification of pharmacodynamic and pharmacokinetic factors affecting drug response and side effects, thus optimizing therapy selection.
Supports both clinical and research applications by providing insight into underlying neurobiological mechanisms of psychiatric symptoms.
Documented Applications
Guiding treatment of treatment resistant depression, bipolar disorder, schizophrenia, anxiety disorders, PTSD, autism, ADHD, and other neuropsychiatric disorders.
Aiding in diagnosis and phenotyping of neuropsychiatric disorders using genotype and biomarker information.
Monitoring patient response and treatment progression by longitudinal biomarker assessment.
Providing personalized medicine approaches for selecting neurotherapeutic agents including drugs, medical foods, and non-pharmaceutical interventions.
Supporting clinical decisions related to drug metabolism and potential drug-drug or herb-drug interactions based on pharmacokinetic biomarker data.
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