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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Cases
Patients with a confirmed diagnosis of Vitiligo within the study period will be included as cases for analysis.
Other: Exposure of mental health condtion of interest
Common mental health conditions consist of depressive episodes, recurrent depressive disorder and anxiety disorder.
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.
Other: Exposure of mental health condtion of interest
Common mental health conditions consist of depressive episodes, recurrent depressive disorder and anxiety disorder.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Prevalence of common mental health conditions (depressive episodes) in adult people diagnosed with vitiligo and matched controls without vitiligo.
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
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
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
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.
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
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.
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
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
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
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).
Within two years of vitiligo diagnosis. For matched controls, within two years of the date of diagnosis of their matched case.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Sociodemographic groups are defined by 10-year age category, sex, socio-economic status and ethnicity.
Within two years of vitiligo diagnosis. For matched controls, within two years of the date of diagnosis of their matched case.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Momentum Data

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 18, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 21, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 19, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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