ATLAS-1: Advanced Trial for Longitudinal Assessment in Salma 1 (ATLAS-1)

April 7, 2026 updated by: Salma Health, Inc.
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • Recruiting
        • Salma Health
        • Contact:
      • Laguna Hills, California, United States, 92653
        • Recruiting
        • Salma Health
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study will enroll up to 5,000 adult participants who are presenting for care with depressed mood and are prescribed and intending to receive standard-of-care treatment with esketamine, conventional TMS or SAINT.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire 9-item (PHQ-9)
Time Frame: Pre-treatment, Post-treatment, 2 weeks posttreatment, and Monthly post-treatment for 12 months
The Patient Health Questionnaire (PHQ-9) is a 9-item multipurpose self-report instrument for screening, diagnosing, monitoring and measuring the severity of depression.
Pre-treatment, Post-treatment, 2 weeks posttreatment, and Monthly post-treatment for 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Salma Health, Inc.

Collaborators

Center for Neurohealth, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2026

Primary Completion (Estimated)

March 1, 2036

Study Completion (Estimated)

March 1, 2037

Study Registration Dates

First Submitted

April 7, 2026

First Submitted That Met QC Criteria

April 7, 2026

First Posted (Actual)

April 14, 2026

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR-0101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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