Prospective Study to Assess, Outcomes and Healthcare Resource Use of Current Standard of Care for Patients With Moderate or sEvere MDD Requiring Urgent Symptom Control in a Psychiatric Emergency: POWER
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 220
- 主要终点
- Change From Baseline in Severity of Depression as Assessed by the Montgomery-asberg Depression Rating Scale (MADRS)
研究概览
简要总结
The purpose of the study is to describe the clinical outcomes (severity of depression, severity of suicidality & frequency of suicidal thinking, suicide events) and quality of life (QoL) of participants with symptoms of major depressive disorder (MDD) that have current suicidal ideation with intent.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For Participant and Carer
- •Capacity to provide consent
- •Must sign an informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements
- •Sufficient command of English language to understand the study information and requirements For Participant
- •Participant must be deemed to have current suicidal ideation with intent at the point of study enrollment and be within four days of presenting with suicidal ideation with intent in relation to the current episode For Carer
- •Participant and/ or carer report that the carer has a personal relationship with the patient and provides unpaid support or care
排除标准
- •Capacity to provide consent
- •Participant is known to be diagnosed with any of the following conditions: mania, bipolar disorder, psychotic disorder, depression with psychotic features, autism, dementia, intellectual disability
- •Participant is known to be diagnosed with any of the following conditions: mania, bipolar disorder, psychotic disorder, depression with psychotic features, autism, dementia, intellectual disability
结局指标
主要结局
Change From Baseline in Severity of Depression as Assessed by the Montgomery-asberg Depression Rating Scale (MADRS)
时间窗: Baseline, up to 90 days
MADRS is a clinician-rated scale designed to measure changes in depression severity due to antidepressant treatment. The MADRS consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms) for a total possible score of 60. Higher scores represent a more severe condition. The Structured Interview Guide for the MADRS (SIGMA) will be used for the administration of the MADRS assessment.
Change From Baseline in Severity of Suicidality as Assessed by Clinical Global Impression-Severity of Suicidality Revised (CGI-SS-R) Score
时间窗: Baseline, up to 90 days
CGI-SS-R is derived from the Clinical Global Impression Severity Scale (CGI-S), a global rating scale that gives an overall measure of the severity of a participant's illness. The CGI-SS-R rating is scored on a 7-point scale from 0 (normal, not at all suicidal) to 6 (among the most extremely suicidal participants). A higher score indicates a more severe condition and a reduction in score indicates improvement (that is, lower severity of suicidality).
Change From Baseline in Suicide Ideation and Behavior Assessment Tool (SIBAT) Module 7 (Clinician-rated Frequency of Suicidal Thinking [FoST]) Score
时间窗: Baseline, up to 90 days
SIBAT is assessment tool that captures suicidal ideation, behavior, and risk. It permits assessment of change in suicidal ideation and behavior and documents clinician assessment of severity of suicidality and suicide risk. SIBAT has 8 modules divided into 2 major divisions: patient-reported section (Modules 1-5) and clinician-rated section (Modules 6-8). Clinician-rated section has modules for semi-structured interview, clinical global impressions of current severity of suicidality and imminent suicide risk, clinical global impression of long-term suicide risk, and clinical judgment of optimal suicide management. The score anchor point as in participant report frequency of suicidal thinking that is, response options from never to all the time. Module 7-FoST score ranges from 0-5; higher score indicates more severe condition. Negative change in score indicates improvement.
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Scores
时间窗: Baseline, up to 90 days
The EQ-5D-5L is a generic measure of health status. It is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).
次要结局
- Number of Resources Used to Reduce the Risk for Suicide(Up to 90 days)
- Number of Participants who Used Psychopharmacological and Non-pharmacological Drug Therapies(Up to 90 days)
- Number of Participants with Inpatient and Outpatient Care Across Specific Settings and Consultation With Different Healthcare Professionals (HCPs)(Up to 90 days)
- Care Burden as Assessed by EQ-5D-5L Score(Up to 90 days)
- Care Burden as Assessed Work productivity and Activity Impairment Questionnaire (WPAI) Score(Up to 90 days)