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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Paola Pedrelli, Ph.D.
- 전화번호: 617-724-2936
- 이메일: ppedrelli@mgh.harvard.edu
연구 연락처 백업
- 이름: Erik Gee, B.A.
- 전화번호: 857-238-1301
- 이메일: egee2@mgh.harvard.edu
연구 장소
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Massachusetts
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Boston, Massachusetts, 미국, 02114
- 모병
- Depression Clinical Research Program
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연락하다:
- Paola Pedrelli, Ph.D.
- 전화번호: 617-724-2936
- 이메일: ppedrelli@mgh.harvard.edu
-
연락하다:
- Erik Gee
- 전화번호: 857-238-1301
- 이메일: egee2@mgh.harvard.edu
-
수석 연구원:
- Paola Pedrelli, Ph.D.
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Participants will be individuals with Major Depressive Disorder receiving ketamine, esketamine, or TNF inhibitor treatment.
설명
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).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: OTHER
- 시간 관점: PROSPECTIVE
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Montgomery Åsberg Depression Rating Scale (MADRS)
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Generalized Anxiety Disorder-7 (GAD-7)
기간: 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)
기간: 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
|
|
Insomnia Severity Index (ISI)
기간: 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
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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