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Can a 6,000-Person study unlock personalized depression care for asians?

NCT ID NCT06002204

Knowledge-focused Sponsor: University of Texas Southwestern Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time

Summary

The SHAKTI study is a 5-year observational project that will follow 6,000 people of Asian or Pacific Islander descent, aged 10 and older, with depression or related mood disorders. Researchers will collect a wide range of data—including lifestyle, clinical history, blood and stool samples, brain scans, and EEG readings—to identify factors that influence how people respond to antidepressant treatment and what makes some more resilient. The goal is to build predictive models that could one day help doctors choose the most effective treatment for each individual, reducing the guesswork in depression care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to more personalized depression treatments tailored to Asian and Pacific Islander populations, improving outcomes and reducing trial-and-error prescribing.
What could go wrong
As an observational study, it cannot prove cause and effect. The findings may not apply to all Asian subgroups, and the long duration may lead to participant dropout, affecting the robustness of the results.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 6,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Feb 2035

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

10 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Adult or youth aged 10 years or older 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. 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. Have the ability to complete clinical evaluations, neuropsychological testing, and self-report measures. 5. Meet criteria for one of these three groups: 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) 2. Be at risk for developing mood disorders 3. Healthy Control Group Exclusion Criteria: 1. History of schizophrenia, schizoaffective disorders or chronic psychotic disorders based upon a semi-structured diagnostic interview. 2. Unable to provide a stable home address and contact information. 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. Requires immediate hospitalization for psychiatric disorder or suicidal risk as assessed by a licensed study clinician.

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Conditions

The condition(s) this trial relates to.

Behavioral Symptoms Bipolar and Related Disorders bipolar disorder Depression depressive disorder Depressive Disorder, Treatment-Resistant mental disorder mood disorder psychiatric disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bipolar and related disorders Bipolar disorder Depression Mental disorders Mood disorders Treatment resistant depression

Contacts and locations

Locations

  • UT Southwestern Medical Center

    Dallas, Texas, 75390, United States

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