ACTIVE_NOT_RECRUITING

Studying the Health of Asians to Advance Knowledge, Treatments, and Interventions for Depression

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

SHAKTI (from the Sanskrit word for "power") is a 5-year natural history, longitudinal, prospective study of a cohort of 6,000 participants that will help uncover the socio-demographic, lifestyle, clinical, psychological, and neurobiological factors that contribute to antidepressant treatment response (remission, recurrence, relapse and individual outcomes in depressive disorders) and resilience. As this is an exploratory study, we will assess a comprehensive panel of carefully selected participant specific parameters - socio-demographic (age, sex, gender, race, ethnicity, economic); life habits (physical activity, substance use); clinical (medical history, anxious depression, early life trauma), biological (biomarkers in blood, saliva, urine, stool), behavioral (cognitive, emotional), neurophysiological (EEG), and neuroimaging (magnetic resonance imaging; MRI) with the goal of developing the most robust predictive models of depression treatment response and of outcomes.

Official Title

Studying the Health of Asians to Advance Knowledge, Treatments, and Interventions for Depression (SHAKTI)

Quick Facts

Study Start:2024-03-01
Study Completion:2035-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06002204

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:10 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adult or youth aged 10 years or older
  2. 2. Self-identify fully or partially as being of Asian or Pacific Islander descent such as: East Asian, South Asian, Southeast Asian, Southwest Asian, Central Asian, Oceanian, Pacific Islander, Polynesian, Micronesian, Melanesian
  3. 3. Have the ability to speak, read, and understand English. The parent(s) or legal guardians of minors must also speak, read and understand English.
  4. 4. Have the ability to complete clinical evaluations, neuropsychological testing, and self-report measures.
  5. 5. Meet criteria for one of these three groups:
  6. 1. Have a lifetime or a current diagnosis of a mood disorder (such as depression, bipolar disorder, anxiety) based upon a semi- structured diagnostic interview (must be a non-psychotic depressive disorder)
  7. 2. Be at risk for developing mood disorders
  8. 3. Healthy Control Group
  1. 1. History of schizophrenia, schizoaffective disorders or chronic psychotic disorders based upon a semi-structured diagnostic interview.
  2. 2. Unable to provide a stable home address and contact information.
  3. 3. Has any condition for which, in the opinion of the investigator or designee, study participation would not be in their best interest (including but not limited to cognitive impairment, unstable general medical condition, intoxication, active psychosis) or that could prevent, limit, or confound the protocol-specified assessments.
  4. 4. Requires immediate hospitalization for psychiatric disorder or suicidal risk as assessed by a licensed study clinician.

Contacts and Locations

Principal Investigator

Madhukar H Trivedi, MD
PRINCIPAL_INVESTIGATOR
UT Southwestern

Study Locations (Sites)

UT Southwestern Medical Center
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

  • Madhukar H Trivedi, MD, PRINCIPAL_INVESTIGATOR, UT Southwestern

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-01
Study Completion Date2035-02

Study Record Updates

Study Start Date2024-03-01
Study Completion Date2035-02

Terms related to this study

Keywords Provided by Researchers

  • Depression
  • Resilience
  • Asian & Pacific Islanders
  • Mood Disorders
  • Bipolar Disorder
  • Behavioral Symptoms
  • Observational Study

Additional Relevant MeSH Terms

  • Depression
  • Treatment Resistant Depression
  • Mood Disorders
  • Bipolar Disorder
  • Mental Disorders
  • Bipolar and Related Disorders