Link Between Reduction of Suicide Ideation by Esketamine in Add-On and Initial Levels of Psychological Pain and Anhedonia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 456
- 试验地点
- 1
- 主要终点
- Anhedonia
研究概览
简要总结
This study is looking at how intranasal esketamine (a nasal spray) can help reduce suicidal thoughts in patients with severe depression who are experiencing suicidal thoughts. Suicidal depression is a type of depression where people have active thoughts of suicide, which can be harder to treat with regular antidepressants. In fact, some people continue to have suicidal thoughts even after taking antidepressants.
Esketamine has already shown promise in helping reduce suicidal thoughts quickly-often within 24 hours-and these effects can last for up to 25 days. Researchers believe esketamine may work by improving mood-related symptoms like loss of pleasure (called anhedonia) and feelings of hopelessness, which are linked to suicidal thinking. They also think that psychological pain, or emotional distress, might play a role in how well esketamine helps reduce suicidal thoughts.
The goal of this study is to better understand how esketamine works to improve suicidal thoughts and whether certain factors (like mood symptoms or emotional pain) can predict which patients will benefit the most from this treatment.
This study uses data from two earlier clinical trials, called ASPIRE I (NCT03039192) and ASPIRE II (NCT03097133), that tested intranasal esketamine in patients with depression and suicidal thoughts. All data from these studies are publicly available and can be accessed and analyzed through the YODA (Yale University Open Data Access) platform, a database of clinical trial data that is accessible to external researchers.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who participated in the ASPIRE I (NCT03039192) and ASPIRE II (NCT03097133)
排除标准
- •Not applicable
结局指标
主要结局
Anhedonia
时间窗: Measured at 24 hours, 7 days, and 25 days after the first administration of intranasal esketamine vs. placebo
The primary outcome measure is the level of anhedonia, assessed by items 5, 7, 8, and 10 of the Montgomery-Åsberg Depression Rating Scale (MADRS). These items evaluate the loss of interest or pleasure in usual activities, a key symptom related to both depression and suicidal ideation. A higher score indicates greater anhedonia, meaning a more severe loss of interest or pleasure. A decrease in the score over time suggests improvement in the patient's ability to experience pleasure.
次要结局
- Psychological Pain(Measured at 24 hours, 7 days, and 25 days after the first administration of intranasal esketamine vs. placebo.)
- Hopelessness(Measured at 24 hours, 7 days, and 25 days after the first administration of intranasal esketamine vs. placebo.)
- Depressive Symptoms Severity(Assessed at 24 hours, 7 days, and 25 days after the first administration of intranasal esketamine vs. placebo.)
- Severity of Suicidal Thoughts(Measured at 24 hours, 7 days, and 25 days after the first administration of intranasal esketamine vs. placebo.)
- Frequency of Suicidal Ideation(Measured at 24 hours, 7 days, and 25 days after the first administration of intranasal esketamine vs. placebo.)