Recruiting

Esketamine, TMS, SAINT

Sponsor:

Salma Health, Inc.

Code:

NCT07528014

Conditions

Depressed Mood

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

This study will evaluate the feasibility and clinical utility of developing predictive models of treatment response for patients with depressed mood using multimodal clinical data collected in real-world clinical settings. The study will examine outcomes among patients treated with interventions including esketamine, conventional transcranial magnetic stimulation (TMS), or Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT). Retrospective clinical and research data from existing databases may also be incorporated, when available and authorized, to support model development and validation. The goal is to assess whether integrated clinical datasets can be used to support the development of predictive tools that may inform personalized treatment selection in depression.

Conditions

Depressed Mood

Study ID

NCT07528014

Start date

Mar 25, 2026

Status verified date

Apr, 2026

Completion date

Mar, 2037

Anticipated

Primary completion date

Mar, 2036

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adults (≥18 years) of any gender identity presenting for care with a depressed mood.
  • Prescribed treatment with esketamine, conventional TMS, or SAINT as part of standard clinical care.
  • Able to provide informed consent and comply with all study requirements.

Exclusion Criteria:

  • Any condition deemed by the investigator to preclude safe participation in study assessments.

Study Design

Enrollment

5000 participants

Anticipated

Interventions and Outcome Measures

Arms

Esketamine

Patients receiving esketamine for the treatment of depressed mood.

Conventional rTMS

Patients receiving conventional rTMS for the treatment of depressed mood.

SAINT

Patients receiving SAINT for the treatment of depressed mood.

Primary outcome measure

  • Patient Health Questionnaire 9-item (PHQ-9) [ Time Frame: Pre-treatment, Post-treatment, 2 weeks posttreatment, and Monthly post-treatment for 12 months ]

Central Contacts and Locations

Locations

Salma Health

Recruiting

La Jolla, California, United States, 92037

Contacts

Clinical Research Coordinator

858-294-0161research@salmahealth.com

Salma Health

Recruiting

Laguna Hills, California, United States, 92653

Contacts

Clinical Research Coordinator

858-294-0161research@salmahealth.com

More Information

Sponsor

Salma Health, Inc.

Last update posted

Apr 14, 2026

Last verified

Apr, 2026

Keywords

  • Depression
  • transcranial magnetic stimulation (TMS)
  • accelerated TMS
  • SAINT
  • Spravato
  • esketamine
  • Treatment-resistant depression (TRD)
  • Major depressive disorder (MDD)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Salma Health, Inc. on 2026-04-14.