Clinical trial NCT04829669: A Study of Participants With Moderate or Severe Major Depressive Disorder (MDD) Requiring Urgent Symptom Control in a Psychiatric Emergency
Official title: 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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Depressive Disorder, Major
Lead sponsor: Janssen-Cilag Ltd.
Sponsor class: INDUSTRY
First posted: 2021-04-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Severity of Depression as Assessed by the Montgomery-asberg Depression Rating Scale (MADRS)
timeFrame: Baseline, up to 90 days
measure: Change From Baseline in Severity of Suicidality as Assessed by Clinical Global Impression-Severity of Suicidality Revised (CGI-SS-R) Score
timeFrame: Baseline, up to 90 days
measure: Change From Baseline in Suicide Ideation and Behavior Assessment Tool (SIBAT) Module 7 (Clinician-rated Frequency of Suicidal Thinking [FoST]) Score
timeFrame: Baseline, up to 90 days
measure: Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Scores
timeFrame: Baseline, up to 90 days
Secondary outcomes:
measure: Number of Participants with Inpatient and Outpatient Care Across Specific Settings and Consultation With Different Healthcare Professionals (HCPs)
timeFrame: Up to 90 days
measure: Number of Resources Used to Reduce the Risk for Suicide
timeFrame: Up to 90 days
measure: Number of Participants who Used Psychopharmacological and Non-pharmacological Drug Therapies
timeFrame: Up to 90 days
measure: Care Burden as Assessed by EQ-5D-5L Score
timeFrame: Up to 90 days
measure: Care Burden as Assessed Work productivity and Activity Impairment Questionnaire (WPAI) Score
timeFrame: Up to 90 days
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Greater Manchester Mental Health NHSFT
Study officials:
affiliation: Janssen-Cilag Ltd.
name: Janssen-Cilag Ltd. Clinical Trial
role: STUDY_DIRECTOR
References: