Mental Health Associations With Vitiligo

NCT04953338 | Completed Results

• 1 other identifier: P044
• Study Type: observational
• Target: 36,104
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (6)

• 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.

  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

  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.

  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.

  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

  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).

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

Study Arms (2)

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

Exposure of mental health condtion of interest OTHER

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

Cases; Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may not qualify if:

• People with less than 1 year of follow up available

Sponsors & Collaborators

• Momentum Data: lead
• Pfizer: collaborator

Study Sites (1)

Momentum Data Ltd

London, WC1X 8QT, United Kingdom

Location

MeSH Terms

Conditions

Vitiligo; Depressive Disorder; Anxiety Disorders; Phobia, Social; Adjustment Disorders; Substance-Related Disorders; Self-Injurious Behavior; Drug Overdose; Suicide, Attempted

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Mood Disorders; Mental Disorders; Phobic Disorders; Trauma and Stressor Related Disorders; Chemically-Induced Disorders; Behavioral Symptoms; Behavior; Prescription Drug Misuse; Drug Misuse; Suicide

Results Point of Contact

• Title: John Nesnas
• Organization: Pfizer Ltd

john.nesnas@pfizer.com

01304 616161

Study Officials

• Andrew McGovern, MD

  Momentum Data Ltd

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2021
• First Posted: July 7, 2021
• Study Start: June 18, 2021
• Primary Completion: August 30, 2022
• Study Completion: October 21, 2022
• Last Updated: December 2, 2025
• Results First Posted: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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

Locations

GB (1)