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

NCT06002204 | Active Not Recruiting

• 1 other identifier: STU-2023-0616
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Depression Severity

  Longitudinal changes in depression severity measured by Patient Health Questionnaire (PHQ-9) for non-psychotic depressive disorders.

  5 years

Secondary Outcomes (2)

• Functioning

  5 years

• Biomarkers

  5 years

Study Arms (3)

Diagnosed with Mood Disorder

Individuals with a lifetime or a current diagnosis of a mood disorder (based upon a semi-structured diagnostic interview)

Other: Observational Study

At-risk for Developing Mood Disorder

Individuals at risk for developing mood disorders (has history of anxiety disorder, substance use disorder, trauma, or mood disorder that does not meet criteria for MDD or Bipolar Disorder or a first-degree relative with a history of mood disorders)

Other: Observational Study

Healthy Control

Healthy individuals who do not have a psychiatric diagnosis (including no history of mood disorders and no first-degree relative with a history of mood disorders)

Other: Observational Study

Interventions

Observational Study OTHER

No Treatment or Intervention Provided

At-risk for Developing Mood Disorder; Diagnosed with Mood Disorder; Healthy Control

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be adults or youths aged 10 years and older living in Texas who self-identify fully or partially as being of Asian or Pacific Islander descent who have provided informed consent.

You may qualify if:

• Adult or youth aged 10 years or older
• 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
• Have the ability to speak, read, and understand English. The parent(s) or legal guardians of minors must also speak, read and understand English.
• Have the ability to complete clinical evaluations, neuropsychological testing, and self-report measures.
• Meet criteria for one of these three groups:
• 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)
• Be at risk for developing mood disorders
• Healthy Control Group

You may not qualify if:

• History of schizophrenia, schizoaffective disorders or chronic psychotic disorders based upon a semi-structured diagnostic interview.
• Unable to provide a stable home address and contact information.
• 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.
• Requires immediate hospitalization for psychiatric disorder or suicidal risk as assessed by a licensed study clinician.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Biospecimens collected will be: blood, urine, stool, and saliva.

MeSH Terms

Conditions

Depression; Depressive Disorder, Treatment-Resistant; Mood Disorders; Bipolar Disorder; Mental Disorders; Bipolar and Related Disorders; Behavioral Symptoms

Interventions

Observation

Condition Hierarchy (Ancestors)

Behavior; Depressive Disorder

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Madhukar H Trivedi, MD

  UT Southwestern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: August 21, 2023
• Study Start: March 1, 2024
• Primary Completion (Estimated): February 1, 2034
• Study Completion (Estimated): February 1, 2035
• Last Updated: August 21, 2025

Record last verified: 2025-08

Locations

US (1)