Depressive DisorderNCT06412562
M3VAS Validation in Polish Population
An observational study of Depressive Disorder, run by Medical University of Gdansk at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Disorder
- What is being tested?
- The Maudsley 3-item Visual Analogue Scale (M3VAS)
- How many people
- 150 participants
- Where
- 1 sitePoland
- Study dates
- 9 May 2024to Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- 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
Who may be able to join
- Diagnosis as provided by DSM-5 criteria:
- Major depressive disorder (MDD) Bipolar disorder (BD)
Who cannot join
- Diagnosis as provided by DSM-5 criteria:
- Psychotic disorders Current Mania or hypomania within bipolar disorder (BD)
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Medical University of Gdańsk
Gdansk
Alina Wilkowska, MD, PhD, +48 58 584 46 50, alina.wilkowska@gumed.edu.pl
Aleksander Kwaśny, MD, +48 58 584 46 50
About this study
Official title: The Maudsley 3-item Visual Analogue Scale (M3VAS) Validation in Polish Population Diagnosed With Major Depressive Episode
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
- Depressive Disorder
- Being tested
- The Maudsley 3-item Visual Analogue Scale (M3VAS)
- Keywords
- anhedonia; low mood; suicidality; depression; m3vas
- Medical subject headings
- Depressive Disorder, Anhedonia, Consciousness Disorders, Suicidal Ideation, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Maudsley 3-item Visual Analogue Scale (M3VAS)Diagnostic test
Also called 16-item Quick Inventory of Depressive Symptomatology (QIDS-SR-16)
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).
| Study group | Role | What they receive |
|---|---|---|
| Major Depressive Episode | 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. Receives: Diagnostic Test: The Maudsley 3-item Visual Analogue Scale (M3VAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Maudsley 3-item Visual Analogue Scale (M3VAS)
To analyze internal consistency and factor analysis
Measured: Baseline
Secondary outcomes (1)
16-item Quick Inventory of Depressive Symptomatology (QIDS-SR-16)
To analyze convergent validity with The Maudsley 3-item Visual Analogue Scale (M3VAS)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start9 May 2024
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06412562
- Sponsor's protocol ID
- M3VAS_PL
- Status last verified
- May 2024
- First submitted
- 9 May 2024
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 33418379
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Maudsley 3-item Visual Analogue Scale (M3VAS) Validation in Polish Population Diagnosed With Major Depressive Episode
- ClinicalTrials.gov ID
- NCT06412562
- Acronym / sponsor ID
- M3VAS_PL
- Conditions
- Depressive Disorder
- Keywords
- anhedonia; low mood; suicidality; depression; m3vas
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- 9 May 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 14 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Major Depressive Episode | – | Diagnostic Test: The Maudsley 3-item Visual Analogue Scale (M3VAS)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (2 listed)
- Major depressive disorder (MDD) Bipolar disorder (BD)
Key exclusion criteria (2 listed)
- Psychotic disorders Current Mania or hypomania within bipolar disorder (BD)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Maudsley 3-item Visual Analogue Scale (M3VAS)Also: 16-item Quick Inventory of Depressive Symptomatology (QIDS-SR-16)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). | Diagnostic test | Major Depressive Episode |
Primary outcome
The Maudsley 3-item Visual Analogue Scale (M3VAS)
Time frame: Baseline
To analyze internal consistency and factor analysis
1 secondary outcome
16-item Quick Inventory of Depressive Symptomatology (QIDS-SR-16)
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Background: PubMed 33418379Moulton 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depressive Disorder, run by Medical University of Gdansk at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Maudsley 3-item Visual Analogue Scale (M3VAS) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06412562, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.