- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04953338
Mental Health Associations With Vitiligo
November 14, 2025 updated by: Momentum Data
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
36104
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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London, United Kingdom, WC1X 8QT
- Momentum Data Ltd
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- People with less than 1 year of follow up available
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Cases
Patients with a confirmed diagnosis of Vitiligo within the study period will be included as cases for analysis.
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Common mental health conditions consist of depressive episodes, recurrent depressive disorder and anxiety disorder.
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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.
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Common mental health conditions consist of depressive episodes, recurrent depressive disorder and anxiety disorder.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Prevalence of common mental health conditions (depressive episodes) in adult people diagnosed with vitiligo and matched controls without vitiligo.
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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.
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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.
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Adjusted hazard ratio calculated using Cox proportional hazards models
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Within two years of vitiligo diagnosis. For matched controls, within two years of the date of diagnosis of their matched case.
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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.
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Prevalence of common mental health conditions (Anxiety Disorder) in adult people diagnosed with vitiligo and matched controls without vitiligo.
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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.
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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.
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Prevalence of common mental health conditions (Recurrent Depressive Disorder) in adult people diagnosed with vitiligo and matched controls without vitiligo.
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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.
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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.
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Adjusted hazard ratio calclulated using Cox Proportional hazard models
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Within two years of vitiligo diagnosis. For matched controls, within two years of the date of diagnosis of their matched case.
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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.
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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).
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Within two years of vitiligo diagnosis. For matched controls, within two years of the date of diagnosis of their matched case.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Describe the incidence of common mental health conditions (depressive episodes, recurrent depressive disorder and anxiety disorder) in adult people with vitiligo stratified by sociodemographic factors compared to matched controls.
Time Frame: Within two years of vitiligo diagnosis. For matched controls, within two years of the date of diagnosis of their matched case.
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Sociodemographic groups are defined by 10-year age category, sex, socio-economic status and ethnicity.
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Within two years of vitiligo diagnosis. For matched controls, within two years of the date of diagnosis of their matched case.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Andrew McGovern, MD, Momentum Data Ltd
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 18, 2021
Primary Completion (Actual)
August 30, 2022
Study Completion (Actual)
October 21, 2022
Study Registration Dates
First Submitted
June 19, 2021
First Submitted That Met QC Criteria
July 1, 2021
First Posted (Actual)
July 7, 2021
Study Record Updates
Last Update Posted (Estimated)
December 2, 2025
Last Update Submitted That Met QC Criteria
November 14, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Trauma and Stressor Related Disorders
- Drug Misuse
- Mental Disorders
- Behavioral Symptoms
- Chemically-Induced Disorders
- Mood Disorders
- Skin Diseases
- Hypopigmentation
- Pigmentation Disorders
- Phobic Disorders
- Suicide
- Prescription Drug Misuse
- Behavior
- Skin and Connective Tissue Diseases
- Phobia, Social
- Anxiety Disorders
- Depressive Disorder
- Substance-Related Disorders
- Vitiligo
- Self-Injurious Behavior
- Adjustment Disorders
- Suicide, Attempted
- Drug Overdose
Other Study ID Numbers
- P044
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
IPD Sharing Time Frame
The data will be available subject to approvals for two years after the study publication date
IPD Sharing Access Criteria
Data sharing is subject to ADEPT committee approval
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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