Recruiting

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT07931001

Conditions

Major Depressive Disorder (MDD)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

No Intervention: Observational Cohort

Study Details

Brief summary:

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.

Conditions

Major Depressive Disorder (MDD)

Study ID

NCT07931001

Start date

Nov 5, 2026

Status verified date

Nov, 2026

Completion date

Sep 1, 2027

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Interventions

No Intervention: Observational Cohort

This is an observational study. There is no active treatment that is examined.

Primary outcome measure

  • Montgomery Åsberg Depression Rating Scale (MADRS) [ Time Frame: From baseline to Week 4 ]

Central Contacts and Locations

Central contacts

Paola Pedrelli, Ph.D.

617-724-2936ppedrelli@mgh.harvard.edu

Erik Gee, B.A.

857-238-1301egee2@mgh.harvard.edu

Locations

Depression Clinical Research Program

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Paola Pedrelli, Ph.D.

617-724-2936ppedrelli@mgh.harvard.edu

Erik Gee

857-238-1301egee2@mgh.harvard.edu

Principal Investigator:

Paola Pedrelli, Ph.D.

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Nov 12, 2026

Last verified

Nov, 2026

Keywords

  • MDD
  • Major Depressive Disorder
  • Major Depressive Disorder (MDD)
  • Ketamine
  • Esketamine
  • TNF

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-13. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-11-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.