Home › Major Depressive Disorder › NCT07931001
Longitudinal Assessment of Biomarkers Among Patients With MDD
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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).
About the study
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.
What is being tested
- No Intervention: Observational Cohort (other)
Sponsor: Massachusetts General Hospital · Participants: 100 · Started: Nov 5, 2026
Contact the study team
- Paola Pedrelli, Ph.D. · Phone: 617-724-2936
- Erik Gee, B.A. · Phone: 857-238-1301
Official record on ClinicalTrials.gov — NCT07931001
Locations in the U.S.
| Massachusetts | Depression Clinical Research Program, Boston |
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.