Resilience in Adolescent Development (RAD)
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|ClinicalTrials.gov Identifier: NCT03458936|
Recruitment Status : Recruiting
First Posted : March 8, 2018
Last Update Posted : October 5, 2020
|Condition or disease|
|Risk Assessment Resilience, Psychological Depression Mood Disorders Anxiety Disorders|
The primary objective of this initiative is to implement a prospective study that will allow the investigators to 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.
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.
The following variables will be evaluated:
Based on this, the investigators determined that the most promising variables to evaluate are:
- Comprehensive clinical phenotype;
- Magnetic resonance imaging using MRI measures of cortical structure;
- Diffusion tensor imaging (DTI) to assess cortical white matter tract integrity;
- Functional magnetic resonance imaging (fMRI) using multiple tasks to assess brain activation patterns to both emotional conflict and reward-dependent learning tasks;
- Quantitative electroencephalography (EEG) to assess cortical and subcortical brain activation patterns, using advanced EEG processing techniques;
- Cortical evoked EEG potentials;
- Behavioral neuropsychological tasks to include reaction time, and motor processing speed;
- DNA, mRNA, and plasma, urine and saliva protein and metabolomics samples, collected at baseline and throughout the study
- Socio-economic, demographic and life habits parameters.
Planned analyses include: Assessment of individual moderators/mediators: The first set of analyses will test an a priori list of individual variables for status as moderators and mediators. Depression symptom change from baseline will be measured using the Inventory of Depressive Symptomatology-Clinician (IDS-C). Tolerability will be measured using the Frequency, Intensity, and Burden of Side Effects Rating (FIBSER) and the Treatment Emergent Symptom Scale (TESS). Other measures (i.e., treatment response, remission) may also be used and correlated variables collected in the study.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1500 participants|
|Target Follow-Up Duration:||10 Years|
|Official Title:||Resilience in Adolescent Development|
|Actual Study Start Date :||December 2016|
|Estimated Primary Completion Date :||December 2031|
|Estimated Study Completion Date :||December 2032|
- Biomarkers [ Time Frame: 10 years ]protective factors against developing mood disorders (socio-demographic, lifestyle, clinical and behavioral assessments, fluid-based biomarkers, genomics, neuroimaging, EEG and cell-based assays)
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03458936
|Contact: Candice Komachi||RAD@UTSouthwestern.edu|
|Contact: Sangita Sethuram||Sangita.Sethuram@UTSouthwestern.edu|
|United States, Texas|
|UT Southwestern Medical Center||Recruiting|
|Dallas, Texas, United States, 75390|
|Contact: Candice Komachi 214-648-4357 RAD@UTSouthwestern.edu|
|Contact: Sangita Sethuram, MBA 214-648-4357 Sangita.Sethuram@UTSouthwestern.edu|
|Principal Investigator: Madhukar Trivedi, MD|
|Sub-Investigator: Jennifer Hughes, PhD|
|Principal Investigator:||Madhukar Trivedi||UT Southwestern|
|Principal Investigator:||Jennifer Hughes||UT Southwestern|