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Recruiting NCT06412562

M3VAS Validation in Polish Population

Observational Depressive Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: The Maudsley 3-item Visual Analogue Scale (M3VAS).
Who it may be relevant to
Registry conditions: Depressive Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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).

Primary outcome measures

  • The Maudsley 3-item Visual Analogue Scale (M3VAS) [Time frame: Baseline]
Secondary outcome measures (1)
  • 16-item Quick Inventory of Depressive Symptomatology (QIDS-SR-16) [Time frame: Baseline]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Poland · 1 center
  • Medical University of Gdańsk — Gdansk

Publications

  • 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. PMID 33418379

Identifiers

NCT: NCT06412562 · M3VAS_PL

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗