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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cases | Patients with a confirmed diagnosis of Vitiligo within the study period will be included as cases for analysis. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exposure of mental health condtion of interest | Other | Common mental health conditions consist of depressive episodes, recurrent depressive disorder and anxiety disorder. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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This study will use routinely collected and collated data from OPCRD to provide a broadly representative sample of the population of the UK.
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| Name | Affiliation | Role |
|---|---|---|
| Andrew McGovern, MD | Momentum Data Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Momentum Data Ltd | London | WC1X 8QT | United Kingdom |
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.
The data will be available subject to approvals for two years after the study publication date
Data sharing is subject to ADEPT committee approval
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| ID | Title | Description |
|---|---|---|
| FG000 | Cases | Patients with a confirmed diagnosis of Vitiligo within the study period will be included as cases for analysis. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cases | Patients with a confirmed diagnosis of Vitiligo within the study period will be included as cases for analysis. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 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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Deaths, serious adverse events, and nonserious adverse events were not assessed for study participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cases | Patients with a confirmed diagnosis of Vitiligo within the study period will be included as cases for analysis. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Nesnas | Pfizer Ltd | 01304 616161 | john.nesnas@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 18, 2021 | Feb 3, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 5, 2021 | Feb 3, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D014820 | Vitiligo |
| D003866 | Depressive Disorder |
| D001008 | Anxiety Disorders |
| D000072861 | Phobia, Social |
| D000275 | Adjustment Disorders |
| D019966 | Substance-Related Disorders |
| D016728 | Self-Injurious Behavior |
| D062787 | Drug Overdose |
| D013406 | Suicide, Attempted |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Body Mass Index, Categorical | Body Mass Index (BMI) is a based on a participants height and weight. | Count of Participants | Participants |
|
| Smoking Status, Categorical | Count of Participants | Participants |
|
| Alcohol use, Categorical | Count of Participants | Participants |
|
|
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| Primary | Risk of Depressive Episodes Within Adult Patients With Vitiligo | Adjusted hazard ratio calculated using Cox proportional hazards models | Patients with a pre-existing diagnosis of depressive episodes were excluded from this analysis | Posted | Count of Participants | Participants | Within two years of vitiligo diagnosis. For matched controls, within two years of the date of diagnosis of their matched case. |
|
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | 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. |
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | 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. |
|
|
|
| Primary | Risk of Anxiety Disorder Within Adult Patients With Vitiligo | Adjusted hazard ratio calclulated using Cox Proportional hazard models | Patients with a pre-existing diagnosis of anxiety disorder were excluded from the analysis | Posted | Count of Participants | Participants | 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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| Primary | 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). | Patients with a pre-existing diagnosis of recurrent depressive disorder were excluded from the analysis | Posted | Count of Participants | Participants | 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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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D010698 | Phobic Disorders |
| D000068099 | Trauma and Stressor Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D063487 | Prescription Drug Misuse |
| D000076064 | Drug Misuse |
| D013405 | Suicide |