M3VAS Validation in Polish Population

Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06412562
• Other study ID #: M3VAS_PL
• Status: Recruiting
• Start date: May 9, 2024
• Est. completion date: September 2026

Study information

• Verified date: May 2024
• Source: Medical University of Gdansk
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Depressive Disorder

Intervention

Diagnostic Test:
• The Maudsley 3-item Visual Analogue Scale (M3VAS)
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).

Locations

Country	Name	City	State
Poland	Medical University of Gdansk	Gdansk

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Gdansk	King's College London

Country where clinical trial is conducted

Poland, 

References & Publications (1)

Moulton CD, Strawbridge R, Tsapekos D, Oprea E, Carter B, Hayes C, Cleare AJ, Marwood L, Mantingh T, Young AH. The Maudsley 3-item Visual Analogue Scale (M3VAS): Validation of a scale measuring core symptoms of depression. J Affect Disord. 2021 Mar 1;282:280-283. doi: 10.1016/j.jad.2020.12.185. Epub 2020 Dec 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Maudsley 3-item Visual Analogue Scale (M3VAS)	To analyze internal consistency and factor analysis	Baseline
Secondary	16-item Quick Inventory of Depressive Symptomatology (QIDS-SR-16)	To analyze convergent validity with The Maudsley 3-item Visual Analogue Scale (M3VAS)	Baseline