RAD: Resilience in Adolescent Development

Sponsor
University of Texas Southwestern Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT03458936
Collaborator
(none)
1,500
Enrollment
1
Location
192
Anticipated Duration (Months)
7.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The RAD study is a longitudinal study to prospectively characterize the biological mechanisms of resilience in adolescents and young adults at risk for developing depression. The study will capture biomarkers from the domains of socio-demographic and clinical data, cognitive and psychological assessments, fluid-based biomarkers, neuroimaging and EEG. Such biomarkers will compose a human biosignature of resilience and identify risk factors for depression, contributing to effective treatment selection or may represent moderators of response or non-response to treatments in subjects with depression. A cohort of 1,500 participants, age 10-24 will be recruited over a 5 year period. Participants will be followed for 10 years following an initial baseline visit. Study visits are conducted 4 times per year.

Detailed Description

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.

Specific Aims:

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:

  1. Comprehensive clinical phenotype;

  2. Magnetic resonance imaging using MRI measures of cortical structure;

  3. Diffusion tensor imaging (DTI) to assess cortical white matter tract integrity;

  4. Functional magnetic resonance imaging (fMRI) using multiple tasks to assess brain activation patterns to both emotional conflict and reward-dependent learning tasks;

  5. Quantitative electroencephalography (EEG) to assess cortical and subcortical brain activation patterns, using advanced EEG processing techniques;

  6. Cortical evoked EEG potentials;

  7. Behavioral neuropsychological tasks to include reaction time, and motor processing speed;

  8. DNA, mRNA, and plasma, urine and saliva protein and metabolomics samples, collected at baseline and throughout the study

  9. 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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
1500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Resilience in Adolescent Development
Actual Study Start Date :
Dec 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2031
Anticipated Study Completion Date :
Dec 1, 2032

Outcome Measures

Primary Outcome Measures

  1. Biomarkers [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years to 24 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 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.

Exclusion Criteria:
  • 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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1UT Southwestern Medical CenterDallasTexasUnited States75390

Sponsors and Collaborators

  • University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: Madhukar Trivedi, UT Southwestern
  • Principal Investigator: Jennifer Hughes, UT Southwestern

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Madhukar H. Trivedi, MD, Professor of Medicine, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT03458936
Other Study ID Numbers:
  • STU 062016-042
First Posted:
Mar 8, 2018
Last Update Posted:
Oct 7, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Madhukar H. Trivedi, MD, Professor of Medicine, University of Texas Southwestern Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 7, 2021