About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Any condition deemed by the investigator to preclude safe participation in study assessments.
Trial 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.
Trial design
Case-only
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Sponsors and contacts
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Salma Health, Inc.
Lead sponsor
Center for Neurohealth, Inc
Collaborator