A Study of Participants With Moderate or Severe Major Depressive Disorder (MDD) Requiring Urgent Symptom Control in a Psychiatric Emergency (POWER)

June 20, 2025 updated by: Janssen-Cilag Ltd.

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

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.

Study Overview

Status

Withdrawn

Conditions

Depressive Disorder, Major

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United Kingdom
- - Manchester, United Kingdom, M25 3BL
    - Greater Manchester Mental Health NHSFT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Study population consists of participants with confirmed Major Depressive Disorder (MDD) and active suicidal ideation with intent as per healthcare team opinion.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Participants with Major Depressive Disorder (MDD) and Active Suicidal Ideation with Intent Participants with MDD (moderate or severe) and active suicidal ideation with intent as defined/confirmed by healthcare team will be enrolled and treated in accordance with routine clinical practice. The primary data source for this study will be the medical chart review, carer and clinician-reported outcome measures records of each participant.

Group / Cohort

Participants with Major Depressive Disorder (MDD) and Active Suicidal Ideation with Intent

Participants with MDD (moderate or severe) and active suicidal ideation with intent as defined/confirmed by healthcare team will be enrolled and treated in accordance with routine clinical practice. The primary data source for this study will be the medical chart review, carer and clinician-reported outcome measures records of each participant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Severity of Depression as Assessed by the Montgomery-asberg Depression Rating Scale (MADRS) Time Frame: 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.	Baseline, up to 90 days
Change From Baseline in Severity of Suicidality as Assessed by Clinical Global Impression-Severity of Suicidality Revised (CGI-SS-R) Score Time Frame: 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).	Baseline, up to 90 days
Change From Baseline in Suicide Ideation and Behavior Assessment Tool (SIBAT) Module 7 (Clinician-rated Frequency of Suicidal Thinking [FoST]) Score Time Frame: 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.	Baseline, up to 90 days
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Scores Time Frame: 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).	Baseline, up to 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Inpatient and Outpatient Care Across Specific Settings and Consultation With Different Healthcare Professionals (HCPs) Time Frame: Up to 90 days	Number of participants with Inpatient and outpatient care across specific settings and consultation with different healthcare professionals (HCPs) will be reported.	Up to 90 days
Number of Resources Used to Reduce the Risk for Suicide Time Frame: Up to 90 days	Number of Resources (hospitalization, close surveillance, crisis team support etc.) used to reduce the risk for suicide will be reported.	Up to 90 days
Number of Participants who Used Psychopharmacological and Non-pharmacological Drug Therapies Time Frame: Up to 90 days	Number of participants who psychopharmacological drug therapies and non-pharmacological therapies including psychological therapies and electroconvulsive therapy will be reported.	Up to 90 days
Care Burden as Assessed by EQ-5D-5L Score Time Frame: 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).	Up to 90 days
Care Burden as Assessed Work productivity and Activity Impairment Questionnaire (WPAI) Score Time Frame: Up to 90 days	The WPAI consist of four types of scores: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment / absenteeism plus presenteeism) and activity impairment. Outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity that is worse outcomes.	Up to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen-Cilag Ltd.

Investigators

Study Director: Janssen-Cilag Ltd. Clinical Trial, Janssen-Cilag Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 30, 2024

Primary Completion (Estimated)

August 30, 2024

Study Completion (Estimated)

August 30, 2024

Study Registration Dates

First Submitted

March 31, 2021

First Submitted That Met QC Criteria