跳至主要内容
临床试验/NCT07528014
NCT07528014招募中不适用

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

Salma Health, Inc.2 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2026年3月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
5,000
试验地点
2
主要终点
Patient Health Questionnaire 9-item (PHQ-9)

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

研究组 & 干预措施

SAINT

Patients receiving SAINT for the treatment of depressed mood.

Esketamine

Patients receiving esketamine for the treatment of depressed mood.

Conventional rTMS

Patients receiving conventional rTMS for the treatment of depressed mood.

结局指标

主要结局

Patient Health Questionnaire 9-item (PHQ-9)

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Salma Health, Inc.
申办方类型
Other
责任方
Sponsor

研究点 (2)

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