Longitudinal Assessment of Biomarkers Among Patients With MDD
This prospective observational study will evaluate whether speech collected through a smartphone application can be used to assess depressive symptom severity and detect symptom changes among adults with major depressive disorder receiving ketamine, esketamine, or infliximab.
Up to 100 participants will complete brief speech tasks and self-report measures of depression, anxiety, and insomnia at baseline, week 2, and week 4. Clinician-rated depression severity will be assessed at baseline and week 4.
Optional passive smartphone data, including activity and sleep measures, may also be collected. The study will examine the agreement between speech-based model predictions and established clinical assessments, as well as the ability of the model to identify symptom severity and treatment response. The study is observational and will not alter participants' clinical treatment. By evaluating remote speech-based assessments alongside optional passive behavioral monitoring, this research may support more effective measurement-based care and improve the evaluation and management of depression in clinical settings.
研究概览
详细说明
In this observational study, adults with Major Depressive Disorder (MDD) receiving ketamine, esketamine, or infliximab will be followed for up to 4 weeks. Data collection will include smartphone-based speech assessments, clinician-rated assessments of depression, self-report measures of depression, anxiety, and insomnia, and optional passive monitoring of sleep and activity patterns through a mobile application. The study will use machine learning and statistical methods to analyze speech-derived and behavioral data and to develop and evaluate digital biomarkers for assessing depression severity, tracking changes in symptoms over time, and predicting treatment response.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Paola Pedrelli, Ph.D.
- 电话号码：617-724-2936
- 邮箱：ppedrelli@mgh.harvard.edu
研究联系人备份
- 姓名：Erik Gee, B.A.
- 电话号码：857-238-1301
- 邮箱：egee2@mgh.harvard.edu
学习地点
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Massachusetts
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Boston、Massachusetts、美国、02114
- 招聘中
- Depression Clinical Research Program
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接触：
- Paola Pedrelli, Ph.D.
- 电话号码：617-724-2936
- 邮箱：ppedrelli@mgh.harvard.edu
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接触：
- Erik Gee
- 电话号码：857-238-1301
- 邮箱：egee2@mgh.harvard.edu
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首席研究员：
- Paola Pedrelli, Ph.D.
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Participants will be individuals with Major Depressive Disorder receiving ketamine, esketamine, or TNF inhibitor treatment.
描述
Inclusion Criteria:
- Clinical diagnosis of MDD confirmed via chart review
- Aged 18 years or older
- Fluent in reading and speaking English
- Capable of providing informed consent and complying with the protocol in the estimation of the investigator.
- Capable of operating the Callyope app
- Capable of completing speech tasks
- Owning a smartphone
Exclusion Criteria:
- Meeting DSM-5 criteria for any psychotic disorder (e.g., schizophrenia or delusional disorder) or a substance use disorder (excluding mild alcohol and cannabis use disorder, which will be permitted).
学习计划
研究是如何设计的？
设计细节
- 观测模型：OTHER
- 时间观点：PROSPECTIVE
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Montgomery Åsberg Depression Rating Scale (MADRS)
大体时间：From baseline to Week 4
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The MADRS is a clinician-based assessment of depressive symptoms. Higher scores indicate worse symptoms. Total score can range from 0 to 60. |
From baseline to Week 4
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Generalized Anxiety Disorder-7 (GAD-7)
大体时间：At baseline, Week 2, and Week 4
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The GAD-7 is a self-report questionnaire that assesses anxiety symptoms. Total scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms. |
At baseline, Week 2, and Week 4
|
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Quick Inventory of Depressive Symptomatology (QIDS-SR16)
大体时间：At baseline, Week 2, and Week 4
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The QIDS-SR16 is a self-report questionnaire that assesses depressive symptom severity. Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms. |
At baseline, Week 2, and Week 4
|
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Insomnia Severity Index (ISI)
大体时间：At baseline, Week 2, and Week 4
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The ISI is a self-report questionnaire that assesses the severity of insomnia symptoms. Total scores range from 0 to 28, with higher scores indicating more severe insomnia symptoms. |
At baseline, Week 2, and Week 4
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.