Clinical TrialDepressive DisordersRecruiting

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

This observational study (n=5000) will examine adults with depressed mood who are receiving esketamine, conventional rTMS, or SAINT as part of routine care, with the aim of assessing the feasibility and clinical utility of predictive models of treatment response built from multimodal clinical data. It will use integrated real-world datasets to explore whether personalised tools could help guide treatment selection in depression. Participants must be 18 years or older, able to give informed consent, and prescribed one of the listed treatments in standard clinical practice. The main outcome is the Patient Health Questionnaire 9-item (PHQ-9), measured pre-treatment, post-treatment, 2 weeks after treatment, and then monthly for 12 months. Retrospective clinical and research data from existing databases may also be included, where available and authorised, to support model development and validation.

Target Enrollment
5000 participants
Study Type
Phase NA observational
Design
Non-randomized

Detailed Description

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 Arms & Interventions

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.

Participants

Ages
18?
Sexes
Male & Female

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 Details

  • Status
    Recruiting
  • Phase
    Phase NA
  • Type
    observational
  • Design
    Non-randomized
  • Target Enrollment5000 participants
  • Timeline
    Start: 2026-03-25
    End: 2037-03-01
  • Topic

Locations

Salma HealthLa Jolla, California, United States
Salma HealthLaguna Hills, California, United States