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

NCT07528014 | Recruiting

• 1 other identifier: SHR-0101
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Patient Health Questionnaire 9-item (PHQ-9)

  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

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Salma Health, Inc.: lead
• Center for Neurohealth, Inc: collaborator

Study Sites (2)

Salma Health

La Jolla, California, 92037, United States

RECRUITING

Salma Health

Laguna Hills, California, 92653, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Saliva and blood samples will be retained.

MeSH Terms

Conditions

Consciousness Disorders; Depression; Depressive Disorder, Treatment-Resistant; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 14, 2026
• Study Start: March 25, 2026
• Primary Completion (Estimated): March 1, 2036
• Study Completion (Estimated): March 1, 2037
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)