A Real-World Evidence, Single-Arm, Open-Label Study Evaluating the Safety and Efficacy of HPDT-DA-013 Digital Therapeutic in the Treatment of Major Depressive Disorder(MDD)and Generalized Anxiety Disorder(GAD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Happify Inc.
- 入组人数
- 367
- 试验地点
- 2
- 主要终点
- Patient Health Questionnaire-9 (PHQ-9)
研究概览
简要总结
Participants with Major Depressive Disorder (MDD) or Generalized Anxiety Disorder (GAD) will use a prescribed digital therapeutic for 8-10 weeks, and will complete depression and anxiety measures during this time. After the treatment period, participants will be followed monthly for 12 months.
详细描述
This study aims to assess the safety and efficacy of HPDT-DA-013 digital therapeutic in adults ages 22 years and older with MDD or GAD. Participants access HPDT-DA-013 on their smart device or computer and complete treatment over a period of 8-10 weeks. During the treatment period, participants complete PHQ-9 and GAD-7 assessments, as well as safety and medication use questionnaires. After 8-10 weeks, participants will complete end-of-treatment assessments, and access to HPDT-DA-013 will be removed. Participants are then followed for a period of 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 22 years or older at the time of screening
- •Meets DSM-5 diagnostic criteria for Major Depressive Disorder or Generalized Anxiety Disorder
- •Access to and willingness to use computer equipment/smartphone compatible with the product platform over a functional network for the study duration
- •Currently residing in the United States
排除标准
- •Risk of suicide or has attempted suicide within 24 months of the screening visit
- •Moderate to severe substance use disorder
- •Current co-morbid psychiatric diagnosis including PTSD, Schizophrenia, Bipolar Disorder I or II, or Borderline Personality Disorder
- •Currently pregnant or planning to become pregnant during the treatment period
- •Note: Other protocol-defined inclusion/exclusion criteria applied.
结局指标
主要结局
Patient Health Questionnaire-9 (PHQ-9)
时间窗: baseline to end of treatment (8-10 weeks)
A 9-item self-report measure to assess symptoms of depression
Generalized Anxiety Disorder-7 (GAD-7)
时间窗: baseline to end of treatment (8-10 weeks)
A 7-item self-report measure to assess symptoms of anxiety
次要结局
- GAD-7(Through study completion, average of 14 months)
- PHQ-9(Through study completion, average of 14 months)