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

Withdrawn

• Conditions: Depressive Disorder, Major

• Registration Number: NCT04829669
• Lead Sponsor: Janssen-Cilag Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-31
• Study First Submitted QC: 2021-03-31
• Study First Posted: 2021-04-02
• Study Start: 2024-04-30
• Primary Completion: 2024-08-30
• Study Completion: 2024-08-30
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 220

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Severity of Depression as Assessed by the Montgomery-asberg Depression Rating Scale (MADRS)	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	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	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	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).

Secondary Outcome Measures

Name	Time	Method
Number of Resources Used to Reduce the Risk for Suicide	Up to 90 days	Number of Resources (hospitalization, close surveillance, crisis team support etc.) used to reduce the risk for suicide will be reported.
Number of Participants with Inpatient and Outpatient Care Across Specific Settings and Consultation With Different Healthcare Professionals (HCPs)	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.
Number of Participants who Used Psychopharmacological and Non-pharmacological Drug Therapies	Up to 90 days	Number of participants who psychopharmacological drug therapies and non-pharmacological therapies including psychological therapies and electroconvulsive therapy will be reported.
Care Burden as Assessed by EQ-5D-5L Score	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).
Care Burden as Assessed Work productivity and Activity Impairment Questionnaire (WPAI) Score	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.

Trial Locations

Locations (2)

Greater Manchester Mental Health NHSFT; 🇬🇧 Manchester, United Kingdom

Greater Manchester Mental Health NHSFT; 🇬🇧 Manchester, United Kingdom