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Resilience in Adolescent Development (RAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03458936
Recruitment Status : Recruiting
First Posted : March 8, 2018
Last Update Posted : October 21, 2022
Sponsor:
Information provided by (Responsible Party):
Madhukar H. Trivedi, MD, University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date April 5, 2017
First Posted Date March 8, 2018
Last Update Posted Date October 21, 2022
Actual Study Start Date December 2016
Estimated Primary Completion Date December 2031   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 19, 2022)		 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)
Original Primary Outcome Measures
 (submitted: March 1, 2018)		 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)
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Resilience in Adolescent Development
Official Title Resilience in Adolescent Development
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 Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 10 Years
Biospecimen Retention:   Samples With DNA
Description:
Plasma, Urine, Saliva
Sampling Method Probability Sample
Study Population Participants will be males or females between ages 10 and 24 who have provided informed consent.
Condition
  • Risk Assessment
  • Resilience, Psychological
  • Depression
  • Mood Disorders
  • Anxiety Disorders
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 1, 2018)		 1500
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2032
Estimated Primary Completion Date December 2031   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 10 Years to 24 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Ronnie Pedroncelli, BS TRAD@UTSouthwestern.edu
Contact: Sangita Sethuram, MBA Sangita.Sethuram@UTSouthwestern.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03458936
Other Study ID Numbers STU 062016-042
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party Madhukar H. Trivedi, MD, University of Texas Southwestern Medical Center
Original Responsible Party University of Texas Southwestern Medical Center
Current Study Sponsor University of Texas Southwestern Medical Center
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Madhukar Trivedi, MD UT Southwestern
PRS Account University of Texas Southwestern Medical Center
Verification Date October 2022