A Multicenter, Randomized, Double-Blind, Controlled Study Evaluating the Efficacy and Safety of a Digital Therapeutic as an Adjunct to Treatment as Usual Among Women With Mild to Moderate Postpartum Depression
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 9
- 主要终点
- Hamilton Rating Scale for Depression (HAM-D)
研究概览
简要总结
This study evaluates the efficacy of two digital therapeutics, WB001 and ED001, on depressive symptoms among women diagnosed with postpartum depression.
详细描述
This randomized, double-blind, controlled trial evaluates the efficacy and safety of 8 weeks of treatment of two digital therapeutics in a population of women with mild to moderate postpartum depression. Patients will be referred by an obstetrician, pediatrician, or other healthcare professional, or by other digital and site based recruitment methods and, if interested, will complete the pre-screening process. Those confirmed as eligible will be scheduled to attend a screening/baseline onsite visit. Eligible participants will be randomized to one of the two groups and will receive instructions on downloading and using the smartphone application to which they were randomized. Participants will use the app as instructed and will attend telehealth visits to complete assessments for the primary and safety endpoints at Weeks 4 and 8 (EOT).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Must have primary residence in the United States
- •Must be ≤ 92 days postpartum
- •Must be women aged 22-45 years who had onset of a major depressive episode any time during pregnancy or within 4 weeks following delivery
- •Must own or have regular access to a smartphone (Android or iOS smartphone with a recent, supported operating system), and has reliable Wi-Fi access or sufficient data plan to engage with assigned treatment condition for the duration of the study
- •Participants must have current mild-moderate depression as measured by the HAMD-6 score >7 and <13 at screening
- •Participant must have a form of TAU, defined as clinician supervised outpatient care management and includes follow-up visits, medication, psychotherapy, or some combination thereof
- •TAU must be regularly scheduled or stable for at least 4 weeks prior to baseline (BL) visit
排除标准
- •Gestation less than 28 weeks
- •HAMD-6 score ≤7 or ≥13 (severe depression) at screening
- •Currently pregnant or plans to become pregnant within the next 8 weeks
- •History of drug and/or alcohol use disorder within the past 12 months
- •Lifetime history of suicide attempt or ideation with a plan and intent to harm oneself during the current episode of PPD
- •Current or lifetime psychosis
- •Current or lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, and/or homicidal or infanticidal ideation
- •History of antidepressant treatment with ketamine/esketamine, electroconvulsive therapy, vagal nerve stimulation, or a deep brain stimulation device
- •History of treatment-resistant depression (TRD)
- •Fetal demise within the past 18 months
结局指标
主要结局
Hamilton Rating Scale for Depression (HAM-D)
时间窗: Change from Baseline to Post-treatment at Week 8
Measure of depression. This is a 6-item questionnaire, where total scores range from 0 to 22, with higher scores indicating greater severity of depression.
次要结局
- Edinburgh Postpartum Depression Scale (EPDS)(Change Baseline to Post-treatment at Week 8)
- Patient Health Questionnaire (PHQ-9)(Change Baseline to Post-treatment at Week 8)
- Generalized Anxiety Disorder Questionnaire (GAD-7)(Change from Baseline to Post-treatment at Week 8)
- Mother-to-Infant Bonding Scale (MIBS)(Change from Baseline to Post-treatment at Week 8)
- Clinical Global Impressions Scale - Severity of Illness (CGI-S)(Change Baseline to Post-treatment at Week 8)
- Clinical Global Impressions Scale - Global Improvement (CGI-I)(Change from Mid-treatment at Week 4 to Post-treatment at Week 8)
- Patient Global Impression Scale (PGI)(PGI-S: Change from Baseline to Post-treatment at Week 8; PGI-C: Change from Mid-treatment at Week 4 to Post-treatment at Week 8)
- Client Satisfaction Questionnaire (CSQ-8)(Post-treatment at Week 8)