VitiligoNCT04953338
Mental Health Associations With Vitiligo
An observational study of Vitiligo and Depressive Episode, run by Momentum Data at 1 site in United Kingdom.
Trial summary
This cohort study is a large population-based study in the UK to determine the risks of comorbid mental health conditions (including depression, anxiety and other potential psychological complications of vitiligo) in adults with vitiligo compared to controls and to evaluate whether the relative risks may vary by… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vitiligo, Depressive Episode, Recurrent Depressive Disorder
- What is being tested?
- Exposure of mental health condtion of interest
- How many people
- 36,104 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Jun 2021to 21 Oct 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study will use routinely collected and collated data from OPCRD to provide a broadly representative sample of the population of the UK.
Who may be able to join
- All eligible adults ≥18 (as at date of vitiligo diagnosis for cases or start of follow-up for controls) registered with GP practices contributing data to OPCRD between January 1, 2004 and December 31, 2020, were eligible for inclusion in the study.
Who cannot join
- People with less than 1 year of follow up available
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Mental Health Associations With Vitiligo: a Population-based Cohort Study in the UK
This cohort study is a large population-based study in the UK to determine the risks of comorbid mental health conditions (including depression, anxiety and other potential psychological complications of vitiligo) in adults with vitiligo compared to controls and to evaluate whether the relative risks may vary by different ethnicity.
Read the detailed description
This study has two primary outcomes 1) Prevalence and incidence of mental health condtions in people diagnosed with vitiligo compared to matched controls and 2) Primary care and secondary healthcare utilisation in patients diagnosed with vitiligo and having a prevalent depressive conditon compared to matched controls. In addition, the study examines risk of time off work and unemployment in people diagnosed with vitiligo compared to matched controls.
- Conditions
- Vitiligo, Depressive Episode, Recurrent Depressive Disorder, Anxiety Disorders, Social Phobia, Adjustment Disorders
- Being tested
- Exposure of mental health condtion of interest
- Medical subject headings
- Vitiligo, Depressive Disorder, Anxiety Disorders, Phobia, Social, Adjustment Disorders, Substance-Related Disorders, Self-Injurious Behavior, Drug Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure of mental health condtion of interestOther
Common mental health conditions consist of depressive episodes, recurrent depressive disorder and anxiety disorder.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Patients with a confirmed diagnosis of Vitiligo within the study period will be included as cases for analysis. Receives: Other: Exposure of mental health condtion of interest | |
| Controls | The controls will be defined by matching cases with people who have never been diagnosed with vitiligo either prior to or during the study period, by age and sex, at General Practice level. Receives: Other: Exposure of mental health condtion of interest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Depressive Episodes
Prevalence of common mental health conditions (depressive episodes) in adult people diagnosed with vitiligo and matched controls without vitiligo.
Measured: At the time of diagnosis in all people diagnosed with vitiligo 2004-2020 inclusive. For matched controls, the date of diagnosis of their matched case.
Risk of Depressive Episodes Within Adult Patients With Vitiligo
Adjusted hazard ratio calculated using Cox proportional hazards models
Measured: Within two years of vitiligo diagnosis. For matched controls, within two years of the date of diagnosis of their matched case.
Number of Participants With Anxiety Disorder
Prevalence of common mental health conditions (Anxiety Disorder) in adult people diagnosed with vitiligo and matched controls without vitiligo.
Measured: At the time of diagnosis in all people diagnosed with vitiligo 2004-2020 inclusive. For matched controls, the date of diagnosis of their matched case.
Number of Participants With Recurrent Depressive Disorder
Prevalence of common mental health conditions (Recurrent Depressive Disorder) in adult people diagnosed with vitiligo and matched controls without vitiligo.
Measured: At the time of diagnosis in all people diagnosed with vitiligo 2004-2020 inclusive. For matched controls, the date of diagnosis of their matched case.
Risk of Anxiety Disorder Within Adult Patients With Vitiligo
Adjusted hazard ratio calclulated using Cox Proportional hazard models
Measured: Within two years of vitiligo diagnosis. For matched controls, within two years of the date of diagnosis of their matched case.
Risk of Recurrent Depressive Disorder Within Adult Patients With Vitilgo
Adjusted hazard ratio calculated using Cox proportional hazards models. Adjusted for age, gender, ethnicity, social deprivation quintile, body mass index, smoking status, alcohol use and comorbidities (hypertension, hyperlipidaemia, type 2 diabetes, atrial fibrillation, angina, myocardial infarction, heart failure, stroke, chronic kidney disease stages 3-5, chronic obstructive pulmonary disease, asthma, chronic liver disease and dementia).
Measured: Within two years of vitiligo diagnosis. For matched controls, within two years of the date of diagnosis of their matched case.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start18 Jun 2021
- Primary completion30 Aug 2022
- Study completion21 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for VitiligoStudies 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
- Retrospective
- Enrolment
- 36,104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Momentum Data
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Andrew McGovern, MD, Study director, Momentum Data Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04953338
- Sponsor's protocol ID
- P044
- Status last verified
- Nov 2025
- First submitted
- 19 Jun 2021
- Last updated
- 2 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: OPCRD data can be accessed by bone fide researchers for specific research projects subject to approval by Anonymised Data Ethics \& Protocol Transparency (ADEPT) Committee. The data utilised for this study cannot be made available without such approval.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mental Health Associations With Vitiligo: a Population-based Cohort Study in the UK
- ClinicalTrials.gov ID
- NCT04953338
- Acronym / sponsor ID
- P044
- Conditions
- Vitiligo, Depressive Episode, Recurrent Depressive Disorder, Anxiety Disorders, Social Phobia, Adjustment Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36,104 participants (actual)
- Lead sponsor
- Momentum DataIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- 18 Jun 2021 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 21 Oct 2022 (actual)
- First posted
- 7 Jul 2021 (actual)
- Results
- Posted 2 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This cohort study is a large population-based study in the UK to determine the risks of comorbid mental health conditions (including depression, anxiety and other potential psychological complications of vitiligo) in adults with vitiligo compared to controls and to evaluate whether the relative risks may vary by different ethnicity.
Detailed description
This study has two primary outcomes 1) Prevalence and incidence of mental health condtions in people diagnosed with vitiligo compared to matched controls and 2) Primary care and secondary healthcare utilisation in patients diagnosed with vitiligo and having a prevalent depressive conditon compared to matched controls. In addition, the study examines risk of time off work and unemployment in people diagnosed with vitiligo compared to matched controls.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Other: Exposure of mental health condtion of interestPatients with a confirmed diagnosis of Vitiligo within the study period will be included as cases for analysis. |
| Controls | – | Other: Exposure of mental health condtion of interestThe controls will be defined by matching cases with people who have never been diagnosed with vitiligo either prior to or during the study period, by age and sex, at General Practice level. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study will use routinely collected and collated data from OPCRD to provide a broadly representative sample of the population of the UK.
Key inclusion criteria (1 listed)
- All eligible adults ≥18 (as at date of vitiligo diagnosis for cases or start of follow-up for controls) registered with GP practices contributing data to OPCRD between January 1, 2004 and December 31, 2020, were eligible for inclusion in the study.
Key exclusion criteria (1 listed)
- People with less than 1 year of follow up available
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 |
|---|---|---|
| Exposure of mental health condtion of interestCommon mental health conditions consist of depressive episodes, recurrent depressive disorder and anxiety disorder. | Other | Cases, Controls |
Primary outcome
Number of Participants With Depressive Episodes
Time frame: At the time of diagnosis in all people diagnosed with vitiligo 2004-2020 inclusive. For matched controls, the date of diagnosis of their matched case.
Prevalence of common mental health conditions (depressive episodes) in adult people diagnosed with vitiligo and matched controls without vitiligo.
Risk of Depressive Episodes Within Adult Patients With Vitiligo
Time frame: Within two years of vitiligo diagnosis. For matched controls, within two years of the date of diagnosis of their matched case.
Adjusted hazard ratio calculated using Cox proportional hazards models
Number of Participants With Anxiety Disorder
Time frame: At the time of diagnosis in all people diagnosed with vitiligo 2004-2020 inclusive. For matched controls, the date of diagnosis of their matched case.
Prevalence of common mental health conditions (Anxiety Disorder) in adult people diagnosed with vitiligo and matched controls without vitiligo.
Number of Participants With Recurrent Depressive Disorder
Time frame: At the time of diagnosis in all people diagnosed with vitiligo 2004-2020 inclusive. For matched controls, the date of diagnosis of their matched case.
Prevalence of common mental health conditions (Recurrent Depressive Disorder) in adult people diagnosed with vitiligo and matched controls without vitiligo.
Risk of Anxiety Disorder Within Adult Patients With Vitiligo
Time frame: Within two years of vitiligo diagnosis. For matched controls, within two years of the date of diagnosis of their matched case.
Adjusted hazard ratio calclulated using Cox Proportional hazard models
Risk of Recurrent Depressive Disorder Within Adult Patients With Vitilgo
Time frame: Within two years of vitiligo diagnosis. For matched controls, within two years of the date of diagnosis of their matched case.
Adjusted hazard ratio calculated using Cox proportional hazards models. Adjusted for age, gender, ethnicity, social deprivation quintile, body mass index, smoking status, alcohol use and comorbidities (hypertension, hyperlipidaemia, type 2 diabetes, atrial fibrillation, angina, myocardial infarction, heart failure, stroke, chronic kidney disease stages 3-5, chronic obstructive pulmonary disease, asthma, chronic liver disease and dementia).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. OPCRD data can be accessed by bone fide researchers for specific research projects subject to approval by Anonymised Data Ethics \& Protocol Transparency (ADEPT) Committee. The data utilised for this study cannot be made available without such approval.
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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.
Andrew McGovern, MD study director
Momentum Data Ltd
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 Vitiligo and Depressive Episode, run by Momentum Data at 1 site in United Kingdom.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 2 Dec 2025. 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 United Kingdom. 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?
Yes. Results are posted in the registry (first posted 2 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Depressive Episodes (time frame: At the time of diagnosis in all people diagnosed with vitiligo 2004-2020 inclusive. For matched controls, the date of diagnosis of their matched case.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2025.