We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
Risk Assessment Resilience, Psychological Depression Mood Disorders Anxiety Disorders

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Teen Development

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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
Plasma, Urine, Saliva

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   10 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Participants will be males or females between ages 10 and 24 who have provided informed consent.
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Ronnie Pedroncelli, BS TRAD@UTSouthwestern.edu
Contact: Sangita Sethuram, MBA Sangita.Sethuram@UTSouthwestern.edu

Locations
Layout table for location information
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         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Madhukar Trivedi, MD UT Southwestern
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
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: 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

Layout table for additional information
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, University of Texas Southwestern Medical Center:
Depression
Adolescence
Resilience
Risk Factor
Biomarker
Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Depression
Anxiety Disorders
Mood Disorders
 Pathologic Processes
Behavioral Symptoms
Mental Disorders