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

Janssen (J&J Innovative Medicine)

Status: Withdrawn

Conditions: Depressive Disorder, Major

Study type: Observational

Funder types: Industry

Identifiers

NCT04829669

54135419MDD4003 (Other Identifier)

CR109009

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 1 patient group

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

Description:

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.