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

NCT ID: NCT04829669

Last Updated: 2025-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-30

Study Completion Date

2024-08-30

Brief Summary

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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

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Conditions

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Depressive Disorder, Major

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen-Cilag Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen-Cilag Ltd. Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag Ltd.

Other Identifiers

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54135419MDD4003

Identifier Type: OTHER

Identifier Source: secondary_id

CR109009

Identifier Type: -

Identifier Source: org_study_id

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