Depressive Disorder, MajorPOWERNCT04829669
A Study of Participants With Moderate or Severe Major Depressive Disorder (MDD) Requiring Urgent Symptom Control in a Psychiatric Emergency
An observational study of Depressive Disorder, Major, run by Janssen-Cilag Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Depressive Disorder, Major
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2024to 30 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: Study population consists of participants with confirmed Major Depressive Disorder (MDD) and active suicidal ideation with intent as per healthcare team opinion.
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
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.
- Conditions
- Depressive Disorder, Major
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Severity of Depression as Assessed by the Montgomery-asberg Depression Rating Scale (MADRS)
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.
Measured: 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
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).
Measured: 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
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.
Measured: Baseline, up to 90 days
Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Scores
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).
Measured: Baseline, up to 90 days
Secondary outcomes (5)
Number of Participants with Inpatient and Outpatient Care Across Specific Settings and Consultation With Different Healthcare Professionals (HCPs)
Number of participants with Inpatient and outpatient care across specific settings and consultation with different healthcare professionals (HCPs) will be reported.
Measured: Up to 90 days
Number of Resources Used to Reduce the Risk for Suicide
Number of Resources (hospitalization, close surveillance, crisis team support etc.) used to reduce the risk for suicide will be reported.
Measured: Up to 90 days
Number of Participants who Used Psychopharmacological and Non-pharmacological Drug Therapies
Number of participants who psychopharmacological drug therapies and non-pharmacological therapies including psychological therapies and electroconvulsive therapy will be reported.
Measured: Up to 90 days
Care Burden as Assessed by EQ-5D-5L Score
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).
Measured: Up to 90 days
Care Burden as Assessed Work productivity and Activity Impairment Questionnaire (WPAI) Score
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.
Measured: Up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start30 Apr 2024 (estimated)
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Why it stopped: The study has faced delays in past years - COVID-19 pandemic and recruitment of a sensitive population. New challenges have led to this cancellation decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag Ltd. Clinical Trial, Study director, Janssen-Cilag Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04829669
- Sponsor's protocol ID
- CR109009
- Other IDs
- 54135419MDD4003
- Acronym
- POWER
- Status last verified
- Jun 2025
- First submitted
- 31 Mar 2021
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04829669
- Acronym / sponsor ID
- POWER / CR109009
- Conditions
- Depressive Disorder, Major
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study has faced delays in past years - COVID-19 pandemic and recruitment of a sensitive population. New challenges have led to this cancellation decision.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Janssen-Cilag Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Apr 2024 (estimated)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 2 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Study population consists of participants with confirmed Major Depressive Disorder (MDD) and active suicidal ideation with intent as per healthcare team opinion.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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).
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.
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).
5 secondary outcomes
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 Resources Used to Reduce the Risk for Suicide
Time frame: Up to 90 days
Number of Participants who Used Psychopharmacological and Non-pharmacological Drug Therapies
Time frame: Up to 90 days
Care Burden as Assessed by EQ-5D-5L Score
Time frame: Up to 90 days
Care Burden as Assessed Work productivity and Activity Impairment Questionnaire (WPAI) Score
Time frame: Up to 90 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen-Cilag Ltd. Clinical Trial study director
Janssen-Cilag Ltd.
Questions about this trial
What is this clinical trial studying?
An observational study of Depressive Disorder, Major, run by Janssen-Cilag Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Severity of Depression as Assessed by the Montgomery-asberg Depression Rating Scale (MADRS) (time frame: Baseline, up to 90 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.