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Life sciences · Observational Study
ClinicalTrials.gov · September 17, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT06002204). This is a study registration, not published results. Lead sponsor: University of Texas Southwestern Medical Center. Recruitment status: ACTIVE_NOT_RECRUITING. Study type: OBSERVATIONAL. Enrollment: 6000 participants (ESTIMATED). Conditions: Depression, Treatment Resistant Depression, Mood Disorders, Bipolar Disorder, Mental Disorders, Bipolar and Related Disorders. Interventions: OTHER: Observational Study. Primary outcome measures: Depression Severity , 5 years. 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.