NCT04655924已完成不适用
Artificial Intelligence in Depression - Medication Enhancement: A Randomized, Patient and Rater Blinded, Active-Controlled Trial of a Hybrid-Classic/Machine-Learning Enabled Clinical Decision Aid for Personalized and Individualized Pharmacological Depression Treatment Selection
Aifred Health22 个研究点 分布在 2 个国家目标入组 94 人开始时间: 2022年6月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 22
- 主要终点
- Rate of Safety - Adverse Events
研究概览
简要总结
This study will determine the safety and potential effectiveness of a digital health platform aimed at improving treatment outcomes for patients with depression by assisting physicians with clinical decision making about depression treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Patient and Rater blinded, Physician partially blinded
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with major depressive disorder by a physician using DSM-V criteria
- •able to provide informed consent
- •patients must confirm that they are comfortable being treated for depression by their physician, who may propose a range of treatment options, such as medications or psychotherapies, consistent with best practice guidelines for depression which are included in the application. Physicians will be required, as in usual practice, to explain treatments to patients and patients will be able to give and withdraw consent for treatment in general or for specific treatments as in usual practice.
排除标准
- •bipolar disorder of any type
- •inability or unwillingness of the individual to give informed consent
- •inability to manage patient in an outpatient setting (i.e. imminent suicidality)
- •active major depression is not the main condition being treated (i.e. the patient has depressive symptoms in the context of severe substance abuse or a psychotic disorder, but a primary diagnosis of major depressive episode (MDE) cannot be made or would result in inappropriate care).
- •inability to use the tool (i.e. patient cannot interface with a mobile phone or computer due to delirium, or another medical condition)* *Note that for patients who do not have access to mobile or desktop devices but are able to use them or to be trained to use them, these will be provided to them at no cost.
- •Physician Inclusion Criteria:
- •any family doctor/primary care physician or psychiatrist accredited in Canada or the USA who treats patients with depression on at least a monthly basis, as well as residents from these specialities supervised by a participating physician
- •able to provide informed consent
- •comfortable prescribing the range of potential treatments which could have probabilities provided for them by the CDA
- •No Physician Exclusion Criteria
结局指标
主要结局
Rate of Safety - Adverse Events
时间窗: 3 months
Adverse and Serious Adverse Events
Effectiveness in Reduction of Depression Symptoms
时间窗: 3 months
This is approved as a physician partially-blinded study and, as such, physicians are blinded to the primary outcome.
次要结局
- Response Rate(3 months)
- Patient Disability with WHODAS rating scale(3 months)
- Time to Remission(3 months)
研究者
Aifred Health
Clinical Trial Manager
Aifred Health Inc.
研究点 (22)
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