A Confirmatory Study of the Rapid Mood Screener for Bipolar 1 Disorder to Evaluate Capability to Distinguish Between Subjects With Unipolar Major Depressive Disorder and Bipolar 1 in a Real-world Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 423
- 试验地点
- 9
- 主要终点
- Sensitivity of Rapid Mood Screener (RMS)
研究概览
简要总结
Bipolar I Disorder (BP1)is a severe chronic mood disorder characterized by manic and depression. BP1 has high probability of being misunderstood as unipolar major depressive disorder (MDD). The purpose of this study is to confirm Rapid Mood Screener (RMS) effectively classifies participants with BP1.
Rapid Mood Screener (RMS) is a brief 6-item clinician-administered checklist, in which a participant's endorsement of four or more questions should trigger further clinical evaluation for BP1. Approximately 404 participants (303 with confirmed unipolar MDD and 101 with confirmed BP1) will be enrolled in the United States.
Participants will be answering RMS questionnaire and accuracy will be measured against Mini-International Neuropsychiatric Interview (MINI) interview.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •Presenting to provider with primary complaint of new or continuing depressive symptoms.
- •May be treatment naïve even if not in their first depressive episode.
- •Meets one of the following criteria:
- •Previously treated and currently off medication.
- •Currently using an antidepressant, atypical antipsychotic for mood disorder, or mood stabilizer.
排除标准
- •Hospitalized or admitted to the emergency room due to mental health issues in the past 30 days.
- •Currently experiencing a manic episode.
- •History of schizophrenia or depression due to another psychotic disorder or a medical, organic, or drug-induced cause or a neurocognitive disorder (dementia/delirium) (as defined by Diagnostic and Statistical Manual of Mental Disorders [DSM-V] criteria).
- •Participant did not provide informed consent.
结局指标
主要结局
Sensitivity of Rapid Mood Screener (RMS)
时间窗: Day 1
Sensitivity is defined as TP/(TP+FN).
Positive Predictive Value (PPV) of Rapid Mood Screener (RMS)
时间窗: Day 1
PPV is defined as True Positive(TP)/(TP + False Positive (FP)).
Negative Predictive Value (NPV) of Rapid Mood Screener (RMS)
时间窗: Day 1
NPV is defined as True Negative(TN)/(TN + False Negative (FN)).
Specificity of Rapid Mood Screener (RMS)
时间窗: Day 1
Specificity is defined as TN/(TN+FP).
次要结局
未报告次要终点