## Protocol Section
### Identification Module
**NCT ID:** NCT06412562

**Brief Title:** M3VAS Validation in Polish Population

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

#### Organization Study ID Info
**ID:** M3VAS_PL
#### Organization
**Class:** OTHER
**Full Name:** Medical University of Gdansk
### Status Module
#### Completion Date
**Date:** 2026-09

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-09

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-09

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-09

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-09
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** King's College London

#### Lead Sponsor

**Class:** OTHER

**Name:** Medical University of Gdansk

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Depressive Disorder

**Keywords:**

- anhedonia; low mood; suicidality; depression; m3vas

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 150

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

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

**Label:** Major Depressive Episode

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Major Depressive Episode

**Description:** 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).

**Name:** The Maudsley 3-item Visual Analogue Scale (M3VAS)

**Other Names:**

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

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** To analyze internal consistency and factor analysis

**Measure:** The Maudsley 3-item Visual Analogue Scale (M3VAS)

**Time Frame:** Baseline

#### Secondary Outcomes

**Description:** To analyze convergent validity with The Maudsley 3-item Visual Analogue Scale (M3VAS)

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

**Time Frame:** Baseline

### Eligibility Module

**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)

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Inpatients referred to the tertiary-reference unit for mood disorders with MDD or BD diagnosis, currently either with current depression or euthymic

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Gdańsk

**Contacts:**

***Contact 1:***

- **Email:** alina.wilkowska@gumed.edu.pl

- **Name:** Alina Wilkowska, MD, PhD

- **Phone:** +48 58 584 46 50

- **Role:** CONTACT

***Contact 2:***

- **Name:** Aleksander Kwaśny, MD

- **Phone:** +48 58 584 46 50

- **Role:** CONTACT

***Contact 3:***

- **Name:** Alina Wilkowska, MD, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 4:***

- **Name:** Aleksander Kwaśny, MD

- **Role:** SUB_INVESTIGATOR

**Country:** Poland

**Facility:** Medical University of Gdańsk

**Status:** RECRUITING

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

### References Module

#### References

**Citation:** 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

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000019964

- Term: Mood Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M7058

- Name: Depression

- Relevance: LOW

- As Found: Unknown

- ID: M7061

- Name: Depressive Disorder

- Relevance: HIGH

- As Found: Depressive Disorder

- ID: M29364

- Name: Suicidal Ideation

- Relevance: LOW

- As Found: Unknown

- ID: M29467

- Name: Anhedonia

- Relevance: LOW

- As Found: Unknown

- ID: M21835

- Name: Mood Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003866

- Term: Depressive Disorder

### Misc Info Module

- Version Holder: 2024-05-31
