An observational study in Major Depressive Disorder (MDD), sponsored by Massachusetts General Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Massachusetts General Hospital · Observational
Among 88 studies in Depressive Disorder, Major by Massachusetts General Hospital — 9 open to participants now, 12 under way, none of them phase 3. Depressive Disorder, Major · Massachusetts General Hospital.
Among the 88 studies in Depressive Disorder, Major by Massachusetts General Hospital, this one is the 4th largest by planned enrollment of the 11 observational ones that give a count, is one of 4 that started in 2026, is one of 11 observational ones, reaches primary completion later than 8 of the 11 other live ones, and was the 88th registered.
3,046 studies on the registry are indexed under Depressive Disorder, Major; 592 are open to participants now.
Browse Depressive Disorder, Major studies →9 of the 88 studies in Depressive Disorder, Major by Massachusetts General Hospital are open now, in 1 country. Recruiting first, the newest first:
Massachusetts General Hospital · Sites in United States
Ages 18+
Massachusetts General Hospital · Sites in United States
Ages 25–50
Massachusetts General Hospital · Sites in United States
Ages 18–65 · Healthy volunteers
Massachusetts General Hospital · Sites in United States
Ages 18+
Massachusetts General Hospital · Sites in United States
Ages 18–85
By country, each count listing its studies:
Of the 412 Depressive Disorder, Major studies recruiting now, 93 (23%) set no upper age limit and 293 (71%) stop at 75 or younger; 55 take children under 18; 98 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
88 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 15 · Phase 3 5 · Phase 4 15
First in 2001; this study’s year is marked. 4 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 100 is below the median of 132 across 403 observational studies indexed under Depressive Disorder, Major.
Median enrollment 40 across the 77 interventional studies, 70 across the 11 observational. Of the 68 that completed or were terminated, 41 (60%) have results posted.
This tab as a report to print or save as PDF → With an account.
Massachusetts General Hospital is the lead sponsor of 2,588 studies on the registry; 446 are open to participants now.
Of its 223 completed or terminated interventional studies of FDA-regulated products, 168 (75%) have results posted.
6 of the studies in Depressive Disorder, Major by Massachusetts General Hospital that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05767593Massachusetts General HospitalClinical Validation of Samsung Smartwatch | 2026-12-01 |
| NCT07610928Massachusetts General HospitalStress Management and Meditative Movements for Asian Americans With Depression and Physical Symptoms | 2027-03-31 |
| NCT05774665Massachusetts General HospitalSpecialized Pro-resolving Lipid Mediators and Treatment Resistant Depression | 2027-03-31 |
| NCT05450432Massachusetts General HospitalLong-Term Maintenance With Ketamine and Esketamine for Reduction of Suicide in High-Risk Patients With Depression | 2027-05-01 |
| NCT05570812Massachusetts General HospitalNeuroactive Steroid to Treat Depressed Mood: A Trial for People With HIV | 2027-06-30 |
Add all 6 to your calendar (.ics) → With an account.
Among the 88 studies in Depressive Disorder, Major by Massachusetts General Hospital, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Participants will be individuals with Major Depressive Disorder receiving ketamine, esketamine, or TNF inhibitor treatment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This is an observational study. There is no active treatment that is examined.
Montgomery Åsberg Depression Rating Scale (MADRS)
The MADRS is a clinician-based assessment of depressive symptoms. Higher scores indicate worse symptoms. Total score can range from 0 to 60.
Time frame: From baseline to Week 4
Generalized Anxiety Disorder-7 (GAD-7)
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.
Time frame: At baseline, Week 2, and Week 4
Quick Inventory of Depressive Symptomatology (QIDS-SR16)
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.
Time frame: At baseline, Week 2, and Week 4
Insomnia Severity Index (ISI)
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.
Time frame: At baseline, Week 2, and Week 4
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Start is estimated for Nov 2026; primary completion for Sep 2027, 9 months later.
Of 121 non-industry observational studies under Depressive Disorder, Major, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 73. This study's planned 9 months is below that.
Counting every sponsor, half of 150 studies reached it within 38 months; a quarter within 21 and three quarters within 67.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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