National Institute of Mental Health (NIMH)
A. Preclinical drug/device development studies, including pharmacology, efficacy and toxicology.
B. Completion of studies as required by the Food and Drug Administration (FDA) for Investigational New Drug (IND) or Radioactive Drug Research Committee (RDRC) application.
C. Studies in normal healthy volunteers to determine a drug?s safety profile, metabolism, etc.
D. Clinical studies in patient/disease population to assess the drug?s effectiveness.
E. Assessment of devices with regard to performance standards related to the FDA approval process.
F. Safety and effectiveness studies of novel medical devices.
G. Evaluation of novel imaging approaches for diagnostic purposes.
H. Clinical studies in support of Pre-Market Approval for biomarkers/medical devices by the FDA.
I. Rapidly develop novel, engaging computer-based cognitive training programs that are based on efficacious neurotherapeutic approaches and which use cognitive training to target a specific neural system/functional domain.
J. Augment existing computerized cognitive interventions to be personalized, engaging, adaptive, sufficiently challenging, and optimal for maximizing real world functional improvements.
K. Test the feasibility, efficacy and potential adverse effects of these programs utilizing measures of functional outcomes in an identified clinical population, particularly those with neuropsychiatric disorders, ASD, and/or HAND, at a specified developmental stage, including measurement of the duration of treatment effects
L. Rapid development and evaluation of mobile based platforms and applications.
Division of Neuroscience and Basic Behavioral Science (DNBBS)
A. Novel imaging probes to study brain structure and function at all levels, from the molecular to the whole organ, using any imaging modality (PET, fMRI, optical, etc.).
B. Drug discovery/drug development of novel compounds which act on molecular pathways (receptors, enzymes, second messengers, etc.) that are not typically targeted with currently available psychiatric drugs, and that have a strong biological justification as a novel mechanism for treatment of psychiatric disorders.
C. Novel screening assays for high throughput acquisition and analysis of data about behavior and the brain, from the level of genes to the level of behavior.
D. Novel technologies that would enable researchers to study how populations of neural cells work together within and between brain regions, in order to understand how changes in neural activity contributes to mental disorders.
E. Complex instrumentation for neuroscience research
F. Complex brain or cellular imaging or analysis.
G. Tools to facilitate the detailed analysis of complex circuits and provide insights into cellular interactions that underlie brain function.
H. Proof-of-concept testing and development of new technologies and novel approaches for large scale recording and manipulation of neural activity, at or near cellular resolution, at multiple spatial and/or temporal scales, in any region and throughout the entire depth of the brain
I. Iterative refinement of such tools and technologies with the end-user community with an end-goal of scaling manufacture towards reliable, broad, sustainable dissemination and incorporation into regular neuroscience practice.
J. Novel informatics tools to facilitate the sharing of complex data sets between laboratories.
K. Novel tools for investigating brain-derived GPCRs in mental health research.
Division of Developmental Translational Research (DDTR)
A. Develop, test and validate reliable and stable biomarkers that can identify at-risk individuals prior to disease onset, improve diagnosis, predict treatment response, or measure disease progression. Biomarkers are also needed in clinical trials to identify dose ranges, to identify a specific subpopulation of subjects to enroll in a treatment trial, or to measure efficacy or toxicity/side effects.
B. Develop novel and targeted interventions (pharmacological, cognitive, behavioral, computer, or device-based) that affect particular neural circuits and signaling pathways relevant to the developmental trajectory of the disease.
C. Based on expanded knowledge of neurobehavioral trajectories, develop novel objective assessment tools that can identify early signs of risk or onset of recurrence of particular mental disorders or in domains of functioning (see MH?s RDoC project: https://www.nimh.nih.gov/research-funding/rdoc/index.shtml) for pediatric populations.
D. Develop computational behavioral assessment tools that can be used across ages, species, and cultures to evaluate dysfunction in domains relevant to mental disorders (e.g., mood dysregulation, deficits in executive function).
E. Develop computational platforms to enable the integration and sharing of data characterizing typical and atypical developmental trajectories in humans and non-human animals.
F. Clinical research tools.
Division of Adult Translational Research and Treatment Development (DATR)
A. Develop valid measures of the various constructs in the Research Domain Criteria (RDoC) matrix (see https://www.nimh.nih.gov/research-funding/rdoc/index.shtml ), e.g., neurocognitive tasks, psychometrically sophisticated questionnaires, measures of behavior, and biomarkers, into a commercial product.
B. Conduct early stage, proof of concept clinical trials to advance the development of novel therapeutics. The clinical trials are expected to include biological/behavioral data to assess target engagement and to help determine potential success or failure of the compound before moving on to larger clinical trials (see NOT-MH-11-015 https://grants.nih.gov/grants/guide/notice-files/NOT-MH-11-015.html).
C. Develop, test and validate reliable and stable biomarkers that can identify at-risk individuals prior to disease onset, improve diagnosis, predict treatment response, or to measure disease progression. Biomarkers are also needed in clinical trials to identify dose ranges, to identify a specific subpopulation of subjects to enroll in a treatment trial, or to measure efficacy or toxicity/side effects.
D. Develop clinical risk assessment instruments that encompass multiple domains (e.g., genetic, neurobiological, and environmental), are sensitive to developmental stage, and have high predictive power for the onset or recurrence of mental illness.
E. Develop novel and targeted interventions (pharmacological, behavioral, or devices) that affect particular neural circuits and signaling pathways relevant to the developmental trajectory of the disease.
F. Develop electronic sensors, monitoring devices and systems, and data analysis software for automated detection and diagnosis of mental disorders and key transdiagnostic dimensions of psychopathology.
G. Develop risk assessment measures, methods and paradigms capable of evaluating individualized risk for developing mental disorders, or for developing particular benefits or harms during treatment for mental disorders, and communicating such probabilistic information to patients and their families in a readily understandable manner.
H. Clinical research tools.
Division of AIDS Research (DAR)
A. Develop and test novel, non-invasive diagnostic approaches (instrumentation, imaging, biomarkers, central nervous system [CNS] cell-based in vitro models) to detect neurocognitive dysfunction associated with HIV-1 infection and innovative technologies to study the mechanisms involved in HIV-1 associated neuropathogenesis and persistence of HIV-1 in the CNS or strategies to prevent viral resurgence in the CNS upon cessation of anti-retroviral therapy.
B. Design and test novel therapeutic strategies aimed at amelioration of HIV-1 associated neurocognitive disorders (HAND) and eradication of HIV-1 from CNS reservoirs or strategies to prevent viral resurgence in the CNS upon cessation of anti-retroviral therapy.
C. Discover and develop innovative technologies for targeting therapies to the brain, including antiretroviral drugs, nanotechnology, imaging tools to study HIV-aging interactions or HIV-related neurodegeneration and neuroprotective strategies with improved capability to cross the blood-brain barrier for amelioration of HAND.
D. Design new strategies to reduce adverse effects of anti-retroviral drugs such as neuropsychiatric side effects and drug-drug interactions.
E. Develop or adapt neurological/neuropsychological/neurobehavioral assessments to evaluate HIV-1 associated abnormalities in adults or children in resource poor environments that are adaptable to different cultures and languages.
F. Develop innovative approaches to improve the scientific assessment of HIV sexual risk behavior or medication adherence through wireless technologies, remote sensing devices, biomarkers, or other novel methods.
G. Develop and test tools, curricula, and strategies that seek to reduce documented racial/ethnic, gender, and age-related disparities in HIV infection or in HIV treatment adherence and treatment outcomes.
H. Develop novel tools and approaches to identify, recruit, enroll, and/or retain those most vulnerable to HIV/AIDS (e.g., African-American MSM, adolescents) in HIV prevention research and/or initiatives.
I. Develop and test tools, curricula, or other approaches designed to facilitate the effective implementation of emerging biomedical HIV prevention methods (e.g., pre-exposure prophylaxis, microbicides, circumcision, etc.), including but not limited to approaches that address behavioral aspects of biomedical prevention (e.g., provider knowledge and training; patient uptake, adherence, HIV screening, and risk-reduction counseling; adverse event monitoring, etc.).
J. Develop or adapt and evidence-based HIV sexual risk reduction, psychosocial coping, or treatment adherence interventions for delivery through the internet or mobile devices, with the aim of expanding intervention access, fidelity of delivery, and/or intervention tailoring.
K. Develop novel tools and approaches designed to improve HIV treatment outcomes by rapidly linking individuals diagnosed with HIV to primary medical care, enhancing patient readiness for initiation of antiretroviral medications, improving and sustaining patient adherence to antiretroviral medications, and/or improving patient retention in medical care.
L. Develop innovative approaches designed to improve the quality of HIV testing, (including rapid home based HIV antibody tests), HIV counseling, prevention, and treatment services by strengthening patient-provider communication and/or modifying the decision-making processes and practice behaviors of health care providers.
M. Develop innovative approaches designed to improve the uptake and understanding of rapid home based HIV antibody tests by key populations at higher risk for HIV as well as innovative interventions that can be paired with home test kits to increase linkage and engagement in HIV care for those testing positive.
N. Develop novel information technology tools designed to improve dissemination of evidence-based interventions and assist healthcare providers, community-based organizations, and professional or advocacy organizations in identifying, adopting, and implementing proven HIV prevention and treatment interventions.
Division of Services and Intervention Research (DSIR)
A. Randomized clinical trials evaluating the effectiveness of known efficacious interventions.
B. Analyses of naturalistic databases to evaluate the effectiveness of known efficacious interventions.
C. Identifying moderators and mediators of intervention effects as a step to design and test personalized interventions.
D. Evaluating the combined or sequential use of interventions.
E. Determining the optimal length of intervention, establishing the utility of continuation or maintenance treatment (that is, for prevention of relapse or recurrence).
F. Evaluating the long-term impact of efficacious interventions on symptoms, functioning, and quality of life.
Services research covers all mental health services research issues across the lifespan and disorders, including but not limited to:
A. Services organization, delivery (process and receipt of care), and related health economics at the individual, clinical, program, community and systems levels in specialty mental health, general health, and other delivery settings (such as the workplace).
B. Interventions to improve the quality and outcomes of care.
C. Enhanced capacity for conducting services research.
D. The clinical epidemiology of mental disorders across all clinical and service settings.
E. The dissemination and implementation of evidence-based interventions into service settings.
- Agency: Department of Health and Human Services,Department of Health and Human Services
- Program: SBIR
- Phase: Phase I
- Release Date: August 05, 2015
- Open Date: August 05, 2015
- Close Date: April 05, 2016
- URL: https://grants.nih.gov/grants/guide/pa-files/PA-15-269.html