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Recruiting NCT06412562

NCT06412562 M3VAS Validation in Polish Population

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Clinical Trial Summary
NCT ID NCT06412562
Status Recruiting
Phase
Sponsor Medical University of Gdansk
Condition Depressive Disorder
Study Type OBSERVATIONAL
Enrollment 150 participants
Start Date 2024-05-09
Primary Completion 2026-09

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type OBSERVATIONAL
Interventions
The Maudsley 3-item Visual Analogue Scale (M3VAS)

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 150 participants in total. It began in 2024-05-09 with a primary completion date of 2026-09.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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.

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)

Frequently Asked Questions

Who can join the NCT06412562 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06412562 currently recruiting?

Yes, NCT06412562 is actively recruiting participants. Visit ClinicalTrials.gov or contact Medical University of Gdansk to inquire about joining.

Where is the NCT06412562 trial being conducted?

This trial is being conducted at Gdansk, Poland.

Who is sponsoring the NCT06412562 clinical trial?

NCT06412562 is sponsored by Medical University of Gdansk. The trial plans to enroll 150 participants.

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