MedDataX Logo

Mental Health Associations With Vitiligo

NCT ID: NCT04953338

Last Updated: 2022-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

45000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-18

Study Completion Date

2022-10-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cases

Patients with a confirmed diagnosis of Vitiligo within the study period will be included as cases for analysis.

Exposure of mental health condtion of interest

Intervention Type OTHER

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.

Exposure of mental health condtion of interest

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Exposure of mental health condtion of interest

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role collaborator

Momentum Data

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Andrew McGovern, MD

Role: STUDY_DIRECTOR

Momentum Data Ltd

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Momentum Data Ltd

London, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P044

Identifier Type: -

Identifier Source: org_study_id