UT Southwestern Medical Center
Dallas, Texas, 75390, United States
NCT Number: NCT03458936
RAD is a 10-year natural history, longitudinal, prospective assessment study of a cohort of 2,500 participants (ages 10-24 years) that will help uncover the socio-demographic, lifestyle, clinical, psychological, and neurobiological factors that contribute to resilience among children, adolescents, and young adults at-risk for mood and anxiety disorders. As this is an exploratory study, we will assess a comprehensive panel of carefully selected participant specific parameters, including socio-demographic, life habits, clinical, biological, behavioral, neurophysiological, and neuroimaging. The study is designed to observe and collect factors associated with resilience in a non-invasive fashion; no interventions or treatments will be conducted during the project. Assessments will be conducted up to 4 times per year for up to 10 years, as well as a baseline visit. Study visits will be conducted in person whenever feasible but may be completed by phone/mail/computer, if an in-person visit is not possible.
This study is active but is not currently recruiting participants.
10 year–24 year
All sexes
Observational
Dallas, Texas, 75390, United States
The primary objective of this initiative is identify and validate biosignatures of resilience. Specifically, the research will identify protective factors (socio-demographic, lifestyle, clinical and behavioral assessments, fluid-based biomarkers, genomics, neuroimaging, EEG, and cell-based assays) that reduce risk of developing mood and anxiety disorders in adolescents and young adults at risk for these illnesses.
Presence and severity of symptoms will be assessed over 10 years using questionnaires for symptom changes, social factors, and overall quality of life. Other outcomes generated from this study will include rate of change in quantitative measures of brain function, of depression relevant brain regions correlated with systems-levels behavior and other functional neuro-circuitry MRI measures. Rate of change of specified biochemical biomarkers will also be assessed. Integration of these measures will provide an unmatched understanding into the mechanisms of resilience and protection against depression and anxiety disorders and holds tremendous promise for identifying targets for prevention strategies.
Specific Aims of the RAD Study:
Aim 1 - Examine baseline biosignatures and independent factors (demographic, social, environmental, genetic, EEG, and fMRI) associated with resilience in at-risk adolescents and young adults.
Aim 2 - Examine changes in the biomarker factors annually for 10 years to determine for plasticity of these biomarkers.
Aim 3 - Examine the interaction between psychiatric symptoms and changes in the biopsychosocial signature.
Aim 4 - Evaluate psychological, social, and physiological correlates, from mobile based data, of mood changes to construct a model of risk and resilience to depression and mood disorders among adolescents and young adults.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Exclusion for Healthy Controls
Time frame: 10 Years
Longitudinal changes in depression presence and severity of participants without a mood disorder on Patient Health Questionnaire (PHQ-9).
Interpretation of Total Scores:
0-4: Minimal depression or no depression 5-9: Mild depression 10-14: Moderate depression 15-19: Moderately severe depression 20-27: Severe depression
Time frame: 10 Years
Comparison of Longitudinal changes in functioning as measured by Magnetic Resonance Imaging (MRI) in participants without a mood disorder.
Time frame: 10 Years
Comparison of Longitudinal changes in functioning as measured by quantitative electroencephalography (EEG) in participants without a mood disorder.
Time frame: 10 Years
Comparison of longitudinal changes in fluid-based biomarkers as measured by proteomic methods in participants without a mood disorder.
Time frame: 10 Years
Comparison of longitudinal changes in fluid-based biomarkers as measured by metabolomics methods in participants without a mood disorder.
Time frame: 10 Years
Comparison of longitudinal changes in fluid-based biomarkers as measured by transcriptomic methods in participants without a mood disorder.
Time frame: 10 Years
Comparison of longitudinal changes in fluid-based biomarkers as measured by genomic methods in participants without a mood disorder.
Time frame: 10 Years
Comparison of longitudinal changes in fluid-based biomarkers as measured by epigenomic methods in participants without a mood disorder.
University of Texas Southwestern Medical Center
Other
Acronym: RAD
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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