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 21, 2022
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|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 (MRI, EEG) and cell-based assays)
Biospecimen Retention: Samples With DNA
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|Ages Eligible for Study:||10 Years to 24 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Probability Sample|
- Adolescents and young adults aged 10-24, male and female of all races and ethnicity.
- Participants must be English-speaking (because several study assessments are only available in the English language), however the parent(s) or legal guardian may either speak English or Spanish as the consenting process can be conducted bilingually.
- Adults age 18 and older must be able to provide written informed consent; for youth younger than age 18, a parent or legal guardian must provide written informed consent, and the child or teen must provide written informed assent.
- Ability to complete clinical evaluations and neuropsychological testing.
- Individuals who are unable to provide informed consent.
- Participants who are non-English speaking.
- Individuals with any of the following psychotic features: MDD with psychotic features, schizophrenia, schizoaffective disorder, or other Axis I psychotic disorder.
- Individuals with a depression diagnosis or a history of depression diagnosis at the initial visit (participants who develop depression during the longitudinal follow-up will continue in the study).
- A PHQ-9 score of 10 or greater.
- Individuals who are unable to provide a permanent home address and contact information.
- Individuals with any condition for which, in the opinion of the investigator, study participation would not be in their best interest (e.g., compromise their well-being) or that could prevent, limit, or confound the protocol-specified assessments.
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: Ronnie Pedroncelli, BS||TRAD@UTSouthwestern.edu|
|Contact: Sangita Sethuram, MBA||Sangita.Sethuram@UTSouthwestern.edu|
|United States, Texas|
|UT Southwestern Medical Center||Recruiting|
|Dallas, Texas, United States, 75390|
|Contact: Ronnie Pedroncelli, BS 214-648-4357 TRAD@UTSouthwestern.edu|
|Contact: Sangita Sethuram, MBA 214-648-4357 Sangita.Sethuram@UTSouthwestern.edu|
|Principal Investigator: Madhukar Trivedi, MD|
|Principal Investigator:||Madhukar Trivedi, MD||UT Southwestern|
|Responsible Party:||Madhukar H. Trivedi, MD, Professor of Medicine, University of Texas Southwestern Medical Center|
|Other Study ID Numbers:||
|First Posted:||March 8, 2018 Key Record Dates|
|Last Update Posted:||October 21, 2022|
|Last Verified:||October 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|