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NCT Number: NCT06412562

M3VAS Validation in Polish Population

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Gdańsk

Gdansk, Poland

Location status: Recruiting

Location contact

Aleksander Kwaśny, MD

CONTACT

+48 58 584 46 50

Aleksander Kwaśny, MD

SUB_INVESTIGATOR

Alina Wilkowska, MD, PhD

CONTACT

[email protected]

+48 58 584 46 50

Alina Wilkowska, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

The Maudsley 3-item Visual Analogue Scale (M3VAS)

Diagnostic Test

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: 16-item Quick Inventory of Depressive Symptomatology (QIDS-SR-16)

Primary outcomes

  1. The Maudsley 3-item Visual Analogue Scale (M3VAS)

    Time frame: Baseline

    To analyze internal consistency and factor analysis

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Medical University of Gdansk

Other

Collaborators

  • King's College London

Registry information

Official study title

The Maudsley 3-item Visual Analogue Scale (M3VAS) Validation in Polish Population Diagnosed With Major Depressive Episode

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 14, 2024
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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