Patient Characteristics, Validity of Clinical Diagnoses and Outcomes Associated With Suicidality in Inpatients With Symptoms of Depression (OASIS-D)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,331
- 试验地点
- 1
- 主要终点
- Sheehan Suicidality Tracking Scale (S-STS)
研究概览
简要总结
This 6-month, naturalistic cohort study examines male and female inpatients aged 18 to 75 years i) with any form of unipolar depressive episode (cohort 1); ii) clinical diagnosis of a moderate or severe unipolar depressive episode and suicidal tendencies who agree to participate in a prospective study (cohort 2); and moderate or severe unipolar depressive episodes validated by research interviews and and suicidal tendencies that persist for at least 48 hours after admission who are followed up for 6 months (cohort 3).
详细描述
Epidemiological cross-sectional study in over 3000 inpatients with a clinical diagnosis of major depressive disorder, validation of the clinical diagnosis in 520 patients, and prospective naturalistic 6-month follow-up study of 260 adults with a research interview-confirmed major depressive disorder, with data collection at the following points: at T0 = time of hospitalization (epidemiological study population 1 with data from clinical routine practice), at time T1 of baseline survey in patients with persistent suicidal tendencies, i.e. at least 48 hours after T0 (study population 2 as a subgroup of study population 1, with study information and consent), and in study population 3 (subgroup of study population 2, with study information and consent) at the time of discharge (T2), 3 months after admission to hospital (T3/ by telephone) and 6 months after inpatient admission (T4).
The aim of the study is to characterize the remission or recurrence of suicidal symptoms in the context of a depressive episode. It is expected that the results will help to improve the understanding of the disease process and the further development of effective intervention options.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For Population 1
- •1.any form of unipolar depressive episode
- •For Population 2
- •clinical diagnosis of a moderate or severe unipolar depressive episode
- •clinically diagnosed suicidal tendencies that persist for at least 48 hours after admission to hospital
- •Written consent to participate in the study
- •For Population 3
- •Diagnosis of a moderate or severe unipolar depressive disorder through the structured research interview "Mini International Neuropsychiatric Interview" (M.I.N.I.)
- •Suicidality with a value > / = 1 for item 2 (passive suicidality) OR item 3 (active suicidality) based on the research interview "Sheehan Suicidality Tracking Scale" (S-STS)
- •Written consent to participate in the study
排除标准
- •Patients younger than 18 years or older than 75 years
- •No clinical diagnosis of a depressive episode
- •Depressive episode in the context of a bipolar disorder- secondary depression as a result of physical illness or substance use
- •severe physical symptoms of disease that make participation in the study impossible
- •Pregnancy
- •not being able to understand the study processes
- •incapable of giving informed consent
- •no authorization to give consent due to (limited) incapacity
结局指标
主要结局
Sheehan Suicidality Tracking Scale (S-STS)
时间窗: 20 min
Interview for Suicidality, Suicidal Behavior and Suicide Attempts, the higher the value the worse the outcome, the values can range from 0- 156
Mini-International Neuropsychiatric Interview (M.I.N.I.)
时间窗: 40 min
Semi-structured interview for research diagnosis
次要结局
- Service Use and Resource Form (SURF)(30 min)
- Clinical Global Impression of Imminent Suicide Risk (CGI-SR-I)(1 min)
- Clinical Global Impression of Resolution Suicide Risk (CGI-SR-R)(1 min)
- Clinical Global Impression - Change (CGI-C)(1 min)
- Young Mania Rating Scale (YMRS)(20 min)
- Adherence Questions(5 min)
- Montgomery-Asberg Depression Rating Scale (MADRS)(20 min)
- Clinical Global Impression - Severity (CGI-S)(1 min)
研究者
Prof. Dr. med Christoph Correll
Clinic Director
Charite University, Berlin, Germany