- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06412562
M3VAS Validation in Polish Population
May 9, 2024 updated by: Medical University of Gdansk
The Maudsley 3-item Visual Analogue Scale (M3VAS) Validation in Polish Population Diagnosed With Major Depressive Episode
Low mood and anhedonia represent the fundamental symptoms of major depressive disorder (MDD).
Nevertheless, there is currently no standardized visual analogue scale available to assess the extent of both symptoms concurrently.
The Maudsley 3-item Visual Analogue Scale (M3VAS) is a newly developed tool for participants to self-assess core symptoms of depression: mood quality, pleasure experience (anhedonia), and suicidality.
Despite suicidality not being a primary symptom, it is included due to its critical relevance to safety.
Participants will be instructed to rate the intensity and frequency of their experiences over the preceding two weeks by marking a 100 mm ungraded line.
A researcher will then assign a numerical value based on the mark's position, utilizing the left edge as 0 and the right as 100.
The total score range, combining the three symptoms, ranged from 0 (minimum) to 300 (maximum).
The M3VAS exhibited good psychometric properties in British population.
In this study, the objective is to assess the psychometric properties of the scale within the Polish population diagnosed with major depressive episode within major depressive disorder or bipolar disorder.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Gdańsk, Poland
- Recruiting
- Medical University of Gdansk
-
Contact:
- Alina Wilkowska, MD, PhD
- Phone Number: +48 58 584 46 50
- Email: alina.wilkowska@gumed.edu.pl
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Contact:
- Aleksander Kwaśny, MD
- Phone Number: +48 58 584 46 50
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Principal Investigator:
- Alina Wilkowska, MD, PhD
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Sub-Investigator:
- Aleksander Kwaśny, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Inpatients referred to the tertiary-reference unit for mood disorders with MDD or BD diagnosis, currently either with current depression or euthymic
Description
Inclusion Criteria:
Diagnosis as provided by DSM-5 criteria:
Major depressive disorder (MDD) Bipolar disorder (BD)
Exclusion Criteria:
Diagnosis as provided by DSM-5 criteria:
Psychotic disorders Current Mania or hypomania within bipolar disorder (BD)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Major Depressive Episode
Patients must have a Diagnostic and Statistical Manual 5 (DSM-5) diagnosis of Major Depressive Disorder (MDD) or Bipolar Disorder (BD), as determined by a psychiatrist.
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Patients will be asked to complete The Maudsley 3-item Visual Analogue Scale (M3VAS) and 16-item Quick Inventory of Depressive Symptomatology (QIDS-SR-16).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Maudsley 3-item Visual Analogue Scale (M3VAS)
Time Frame: Baseline
|
To analyze internal consistency and factor analysis
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
16-item Quick Inventory of Depressive Symptomatology (QIDS-SR-16)
Time Frame: Baseline
|
To analyze convergent validity with The Maudsley 3-item Visual Analogue Scale (M3VAS)
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 9, 2024
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2026
Study Registration Dates
First Submitted
May 9, 2024
First Submitted That Met QC Criteria
May 9, 2024
First Posted (Actual)
May 14, 2024
Study Record Updates
Last Update Posted (Actual)
May 14, 2024
Last Update Submitted That Met QC Criteria
May 9, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M3VAS_PL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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