Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06002204 |
| Other study ID # |
STU-2023-0616 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2024 |
| Est. completion date |
February 2035 |
Study information
| Verified date |
March 2024 |
| Source |
University of Texas Southwestern Medical Center |
| Contact |
Afrida Khurshid, BA |
| Phone |
214-998-5877 |
| Email |
SHAKTI[@]UTSouthwestern.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
SHAKTI is a non-randomized, natural history, non-treatment, longitudinal cohort study.
Participants who are receiving standard of care treatment for depression and other
comorbidities from their treating clinician will be allowed to continue such treatments in
this study. There are no experimental study procedures, other than methods used for data
capture (questionnaires, biospecimen collection, EEG, and MRI). Participants will be expected
to visit study site(s) for repeated collection of data (assessments, biospecimens, and
imaging procedures), up to 4 times a year for up to 5 years. A reduced battery of tests is
allowable if subject is not able or willing to complete the full battery after the baseline
visit.
The primary objective of this initiative is to implement a prospective study that will allow
us to identify and validate biosignatures of 1) response to treatments for depression and
depression outcome and 2) resilience and protective factors that reduce the risk of
developing mood and anxiety disorders (using an integrated array of participant specific
data: socio-demographic, lifestyle, clinical and behavioral assessments, fluid-based
biomarkers, genomics, neuroimaging, EEG, and cell-based assays) in a longitudinal cohort of
Asian and Pacific Islander (API) participants with elevated symptoms of a depressive disorder
and participants at risk for these illnesses.
Symptom presence, severity, and remission across various treatment options will be assessed
using questionnaires for symptom changes, antidepressant treatment tolerability 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 depression and hold tremendous
promise for better disease treatment and associated outcomes.
Integration of these measures will provide an unmatched understanding into the mechanisms of
depression and hold tremendous promise for better disease treatment and associated outcomes.
Data will be collected from 3 participant groups:
1. Individuals with a lifetime or a current diagnosis of a mood disorder (based upon a
semi-structured diagnostic interview)
2. 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)
3. Healthy individuals who do not have a psychiatric diagnosis (including no history of
mood disorders and no relative with a history)
We also plan to enroll families within and across all three groups. For the purposes of this
study, we are defining family as a group of two or more people related by either birth,
marriage, or adoption, and residing together. Participants may enroll in this study as an
individual or with their family member(s). If participants and their family member(s) are
enrolled together, their study IDs will be linked so that we may group family data.
Participants will NOT be able to see or learn about their family members' data.
Specific Aims of this Study:
Aim 1. Create the longitudinal SHAKTI research cohort to support a natural history study of
depression, an important source of knowledge to advance depression understanding and
management among API individuals.
Aim 2. Establish a SHAKTI biospecimen resource consisting of blood, plasma, serum, PBMCs,
DNA, RNA, saliva, and urine samples collected from participants at study visits as a platform
for translational research into biochemical and molecular characterization of depression.
Aim 3. Identify neuroimaging and neuropsychiatric parameters that serve as biomarkers or may
be associated with response to specific antidepressant treatment modalities.
Aim 4. Annually examine biosignatures and independent factors (demographic, social,
environmental, genetic, EEG, fMRI) associated with resilience in at-risk participants to
determine changes and plasticity of biomarkers.
Aim 5. Examine the interaction between psychiatric symptoms and changes in the
biopsychosocial signature.
Aim 6. Identify gut microbiome biomarkers that are linked to psychiatric status in
participants with mood disorders.
Aim 7. Identify the association between participants who are family members to compare
biosignatures of depression and resilience.
Aim 8. Sub-Study: Evaluate psychological, social, and physiological correlates, from mobile
device-based data, of depression severity and construct a model to estimate mood based on
these measures.
