Studying the Health of Asians to Advance Knowledge, Treatments, and Interventions for Depression (SHAKTI)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 6,000
- 试验地点
- 2
- 主要终点
- Depression Severity
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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)
干预措施: Observational Study (Other)
Diagnosed with Mood Disorder
Individuals with a lifetime or a current diagnosis of a mood disorder (based upon a semi-structured diagnostic interview)
干预措施: Observational Study (Other)
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 major depressive disorder (MDD) or Bipolar Disorder or a first-degree relative with a history of mood disorders)
干预措施: Observational Study (Other)
结局指标
主要结局
Depression Severity
时间窗: 5 years
Longitudinal changes in depression severity measured by Patient Health Questionnaire (PHQ-9) for non-psychotic depressive disorders.
次要结局
- Functioning(5 years)
- Biomarkers(5 years)
研究者
Madhukar H. Trivedi, MD
Professor of Psychiatry
University of Texas Southwestern Medical Center