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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Paola Pedrelli, Ph.D.
- Phone Number: 617-724-2936
- Email: ppedrelli@mgh.harvard.edu
Study Contact Backup
- Name: Erik Gee, B.A.
- Phone Number: 857-238-1301
- Email: egee2@mgh.harvard.edu
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02114
- Recruiting
- Depression Clinical Research Program
-
Contact:
- Paola Pedrelli, Ph.D.
- Phone Number: 617-724-2936
- Email: ppedrelli@mgh.harvard.edu
-
Contact:
- Erik Gee
- Phone Number: 857-238-1301
- Email: egee2@mgh.harvard.edu
-
Principal Investigator:
- Paola Pedrelli, Ph.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Participants will be individuals with Major Depressive Disorder receiving ketamine, esketamine, or TNF inhibitor treatment.
Description
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).
Study Plan
How is the study designed?
Design Details
- Observational Models: OTHER
- Time Perspectives: PROSPECTIVE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Montgomery Åsberg Depression Rating Scale (MADRS)
Time Frame: From baseline to Week 4
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: At baseline, Week 2, and Week 4
|
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
|
|
Quick Inventory of Depressive Symptomatology (QIDS-SR16)
Time Frame: At baseline, Week 2, and Week 4
|
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)
Time Frame: At baseline, Week 2, and Week 4
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026P001050
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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