ClinicalTrials.gg
CompletedNCT04953338Updated Dec 2, 2025Results posted

Mental Health Associations With Vitiligo

An observational study in Vitiligo, Depressive Episode and Recurrent Depressive Disorder, sponsored by Momentum Data. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-02.

Sponsored by Momentum Data · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
36,104
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Vitiligo
  • Depressive Episode
  • Recurrent Depressive Disorder
  • Anxiety Disorders
  • Social Phobia
  • Adjustment Disorders
  • Substance Abuse
  • Self-Harm, Deliberate
  • Overdose
  • Suicide, Attempted
  • Parasuicide
03

In context

Vitiligo

343 studies on the registry are indexed under Vitiligo; 96 are open to participants now.

This study's enrollment of 36,104 is above the median of 114 across 67 observational studies indexed under Vitiligo.

Browse Vitiligo studies →

Lead sponsor

Momentum Data is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • People with less than 1 year of follow up available
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
36,104 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • 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

Interventions

  • OtherExposure of mental health condtion of interest

    Common mental health conditions consist of depressive episodes, recurrent depressive disorder and anxiety disorder.

06

What researchers measure

Primary outcomes

  1. 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.

    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.

  2. Risk of Depressive Episodes Within Adult Patients With Vitiligo

    Adjusted hazard ratio calculated using Cox proportional hazards models

    Time frame: Within two years of vitiligo diagnosis. For matched controls, within two years of the date of diagnosis of their matched case.

  3. 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.

    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.

  4. 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.

    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.

  5. Risk of Anxiety Disorder Within Adult Patients With Vitiligo

    Adjusted hazard ratio calclulated using Cox Proportional hazard models

    Time frame: Within two years of vitiligo diagnosis. For matched controls, within two years of the date of diagnosis of their matched case.

  6. 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).

    Time frame: Within two years of vitiligo diagnosis. For matched controls, within two years of the date of diagnosis of their matched case.

07

Results

Posted Dec 2, 2025

Participant flow

Participant flow — Overall Study
MilestoneCasesControls
Started722428880
Completed722428880
Not completed00

Outcome measures

PrimaryNumber of Participants With Depressive Episodes

Prevalence of common mental health conditions (depressive episodes) in adult people diagnosed with vitiligo and matched controls without vitiligo.

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.
Reported as:
Count of participants · Participants
Number of Participants With Depressive Episodes
ParticipantsCasesControls
Number of Participants With Depressive Episodes10184007
PrimaryRisk of Depressive Episodes Within Adult Patients With Vitiligo

Adjusted hazard ratio calculated using Cox proportional hazards models

Time frame:
Within two years of vitiligo diagnosis. For matched controls, within two years of the date of diagnosis of their matched case.
Reported as:
Count of participants · Participants
Risk of Depressive Episodes Within Adult Patients With Vitiligo
ParticipantsCasesControls (reference group)
Risk of Depressive Episodes Within Adult Patients With Vitiligo157501
Statistical analysis
  • Controls (reference group) · Hazard ratio (hr): 1.11 · 95% CI 0.92 to 1.32Calculated as the relative risk of a person diagnosed with vitiligo having a depression episode versus people not diagnosed with vitiligo
PrimaryNumber of Participants With Anxiety Disorder

Prevalence of common mental health conditions (Anxiety Disorder) in adult people diagnosed with vitiligo and matched controls without vitiligo.

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.
Reported as:
Count of participants · Participants
Number of Participants With Anxiety Disorder
ParticipantsCasesControls
Number of Participants With Anxiety Disorder5692031
PrimaryNumber 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.

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.
Reported as:
Count of participants · Participants
Number of Participants With Recurrent Depressive Disorder
ParticipantsCasesControls
Number of Participants With Recurrent Depressive Disorder10934305
PrimaryRisk of Anxiety Disorder Within Adult Patients With Vitiligo

Adjusted hazard ratio calclulated using Cox Proportional hazard models

Time frame:
Within two years of vitiligo diagnosis. For matched controls, within two years of the date of diagnosis of their matched case.
Reported as:
Count of participants · Participants
Risk of Anxiety Disorder Within Adult Patients With Vitiligo
ParticipantsCasesControls (reference group)
Risk of Anxiety Disorder Within Adult Patients With Vitiligo122382
Statistical analysis
  • Controls (reference group) · Hazard ratio (hr): 1.23 · 95% CI 1.01 to 1.51Calculated as the relative risk of a person diagnosed with vitiligo having with anxiety disorder versus people not diagnosed with vitiligo
PrimaryRisk 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).

Time frame:
Within two years of vitiligo diagnosis. For matched controls, within two years of the date of diagnosis of their matched case.
Reported as:
Count of participants · Participants
Risk of Recurrent Depressive Disorder Within Adult Patients With Vitilgo
ParticipantsCasesControls (reference group)
Risk of Recurrent Depressive Disorder Within Adult Patients With Vitilgo113312
Statistical analysis
  • Controls (reference group) · Hazard ratio (hr): 1.25 · 95% CI 1.01 to 1.56Calculated as the relative risk of a person diagnosed with vitiligo having with recurrent depressive disorder versus people not diagnosed with vitiligo

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cases———
Controls———

Baseline characteristics

Age, Continuous
Age, Continuous(years)CasesControlsTotal
Median44 (33 to 58)44 (32 to 58)44 (32 to 58)
Age, Customized
Age, Customized(Participants)CasesControlsTotal
Age group, years — 18-29137755346911
Age group, years — 30-39152660877613
Age group, years — 40-49146358227285
Age group, years — 50-59125150066257
Age group, years — 60-6991836474565
Age group, years — 70-7653421552689
Age group, years — 80+155629784
Sex: Female, Male
Sex: Female, Male(Participants)CasesControlsTotal
Female38281530419132
Male33961357616972
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)CasesControlsTotal
White35041401317517
Asian or Asian British106032004260
Black, African, Caribbean or Black British170556726
Mixed66238304
Other25911551414
Not stated1999491148
Missing1966876910735
Body Mass Index, Categorical
Body Mass Index, Categorical(Participants)CasesControlsTotal
<18.5 Underweight174670844
18.5-24.9 Healthy weight212975449673
25-29.9 Overweight2282851110793
30-34.9 Class I obesity108043165396
35-39.9 Class II obesity36716742041
>40 Class III obesity21110131224
Not recorded98151526133
Smoking Status, Categorical
Smoking Status, Categorical(Participants)CasesControlsTotal
Non-smoker2357862910986
Current smoker114758817028
Ex-smoker35211286216383
Passive smoker3077107
Not recorded16914311600
Alcohol use, Categorical
Alcohol use, Categorical(Participants)CasesControlsTotal
Non-drinker2438898411422
Safe use27991110113900
Excess use97036044574
Alcoholism116499615
Not recorded90146925593
08

Study locations

1 site
  • Momentum Data Ltd
    London, WC1X 8QT, United Kingdom
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: 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.

Supporting information: Study protocol

Time frame: The data will be available subject to approvals for two years after the study publication date

Access criteria: Data sharing is subject to ADEPT committee approval

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04953338
Lead sponsor
Momentum Data
Collaborators
Pfizer
Responsible party
Sponsor
First posted
Jul 7, 2021
Start date
Jun 18, 2021
Primary completion
Aug 30, 2022
Completion
Oct 21, 2022
Results posted
Dec 2, 2025
Last update
Dec 2, 2025

Study contacts

Andrew McGovern, MD
study director · Momentum Data Ltd

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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