Trial Outcomes & Findings for Mental Health Associations With Vitiligo (NCT NCT04953338)
NCT ID: NCT04953338
Last Updated: 2025-12-02
Results Overview
Prevalence of common mental health conditions (depressive episodes) in adult people diagnosed with vitiligo and matched controls without vitiligo.
Recruitment status
COMPLETED
Target enrollment
36104 participants
Primary outcome timeframe
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.
Results posted on
2025-12-02
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
7224
|
28880
|
|
Overall Study
COMPLETED
|
7224
|
28880
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mental Health Associations With Vitiligo
Baseline characteristics by cohort
| Measure |
Cases
n=7224 Participants
Patients with a confirmed diagnosis of Vitiligo within the study period will be included as cases for analysis.
|
Controls
n=28880 Participants
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.
|
Total
n=36104 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44 years
n=9 Participants
|
44 years
n=6 Participants
|
44 years
n=9 Participants
|
|
Age, Customized
Age group, years · 18-29
|
1377 Participants
n=9 Participants
|
5534 Participants
n=6 Participants
|
6911 Participants
n=9 Participants
|
|
Age, Customized
Age group, years · 30-39
|
1526 Participants
n=9 Participants
|
6087 Participants
n=6 Participants
|
7613 Participants
n=9 Participants
|
|
Age, Customized
Age group, years · 40-49
|
1463 Participants
n=9 Participants
|
5822 Participants
n=6 Participants
|
7285 Participants
n=9 Participants
|
|
Age, Customized
Age group, years · 50-59
|
1251 Participants
n=9 Participants
|
5006 Participants
n=6 Participants
|
6257 Participants
n=9 Participants
|
|
Age, Customized
Age group, years · 60-69
|
918 Participants
n=9 Participants
|
3647 Participants
n=6 Participants
|
4565 Participants
n=9 Participants
|
|
Age, Customized
Age group, years · 70-76
|
534 Participants
n=9 Participants
|
2155 Participants
n=6 Participants
|
2689 Participants
n=9 Participants
|
|
Age, Customized
Age group, years · 80+
|
155 Participants
n=9 Participants
|
629 Participants
n=6 Participants
|
784 Participants
n=9 Participants
|
|
Sex: Female, Male
Female
|
3828 Participants
n=9 Participants
|
15304 Participants
n=6 Participants
|
19132 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
3396 Participants
n=9 Participants
|
13576 Participants
n=6 Participants
|
16972 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
White
|
3504 Participants
n=9 Participants
|
14013 Participants
n=6 Participants
|
17517 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Asian or Asian British
|
1060 Participants
n=9 Participants
|
3200 Participants
n=6 Participants
|
4260 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Black, African, Caribbean or Black British
|
170 Participants
n=9 Participants
|
556 Participants
n=6 Participants
|
726 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Mixed
|
66 Participants
n=9 Participants
|
238 Participants
n=6 Participants
|
304 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Other
|
259 Participants
n=9 Participants
|
1155 Participants
n=6 Participants
|
1414 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Not stated
|
199 Participants
n=9 Participants
|
949 Participants
n=6 Participants
|
1148 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Missing
|
1966 Participants
n=9 Participants
|
8769 Participants
n=6 Participants
|
10735 Participants
n=9 Participants
|
|
Body Mass Index, Categorical
<18.5 Underweight
|
174 Participants
n=9 Participants
|
670 Participants
n=6 Participants
|
844 Participants
n=9 Participants
|
|
Body Mass Index, Categorical
18.5-24.9 Healthy weight
|
2129 Participants
n=9 Participants
|
7544 Participants
n=6 Participants
|
9673 Participants
n=9 Participants
|
|
Body Mass Index, Categorical
25-29.9 Overweight
|
2282 Participants
n=9 Participants
|
8511 Participants
n=6 Participants
|
10793 Participants
n=9 Participants
|
|
Body Mass Index, Categorical
30-34.9 Class I obesity
|
1080 Participants
n=9 Participants
|
4316 Participants
n=6 Participants
|
5396 Participants
n=9 Participants
|
|
Body Mass Index, Categorical
35-39.9 Class II obesity
|
367 Participants
n=9 Participants
|
1674 Participants
n=6 Participants
|
2041 Participants
n=9 Participants
|
|
Body Mass Index, Categorical
>40 Class III obesity
|
211 Participants
n=9 Participants
|
1013 Participants
n=6 Participants
|
1224 Participants
n=9 Participants
|
|
Body Mass Index, Categorical
Not recorded
|
981 Participants
n=9 Participants
|
5152 Participants
n=6 Participants
|
6133 Participants
n=9 Participants
|
|
Smoking Status, Categorical
Non-smoker
|
2357 Participants
n=9 Participants
|
8629 Participants
n=6 Participants
|
10986 Participants
n=9 Participants
|
|
Smoking Status, Categorical
Current smoker
|
1147 Participants
n=9 Participants
|
5881 Participants
n=6 Participants
|
7028 Participants
n=9 Participants
|
|
Smoking Status, Categorical
Ex-smoker
|
3521 Participants
n=9 Participants
|
12862 Participants
n=6 Participants
|
16383 Participants
n=9 Participants
|
|
Smoking Status, Categorical
Passive smoker
|
30 Participants
n=9 Participants
|
77 Participants
n=6 Participants
|
107 Participants
n=9 Participants
|
|
Smoking Status, Categorical
Not recorded
|
169 Participants
n=9 Participants
|
1431 Participants
n=6 Participants
|
1600 Participants
n=9 Participants
|
|
Alcohol use, Categorical
Non-drinker
|
2438 Participants
n=9 Participants
|
8984 Participants
n=6 Participants
|
11422 Participants
n=9 Participants
|
|
Alcohol use, Categorical
Safe use
|
2799 Participants
n=9 Participants
|
11101 Participants
n=6 Participants
|
13900 Participants
n=9 Participants
|
|
Alcohol use, Categorical
Excess use
|
970 Participants
n=9 Participants
|
3604 Participants
n=6 Participants
|
4574 Participants
n=9 Participants
|
|
Alcohol use, Categorical
Alcoholism
|
116 Participants
n=9 Participants
|
499 Participants
n=6 Participants
|
615 Participants
n=9 Participants
|
|
Alcohol use, Categorical
Not recorded
|
901 Participants
n=9 Participants
|
4692 Participants
n=6 Participants
|
5593 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Cases
n=7224 Participants
Patients with a confirmed diagnosis of Vitiligo within the study period will be included as cases for analysis.
|
Controls
n=28880 Participants
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.
|
|---|---|---|
|
Number of Participants With Depressive Episodes
|
1018 Participants
|
4007 Participants
|
PRIMARY outcome
Timeframe: Within two years of vitiligo diagnosis. For matched controls, within two years of the date of diagnosis of their matched case.Population: Patients with a pre-existing diagnosis of depressive episodes were excluded from this analysis
Adjusted hazard ratio calculated using Cox proportional hazards models
Outcome measures
| Measure |
Cases
n=6206 Participants
Patients with a confirmed diagnosis of Vitiligo within the study period will be included as cases for analysis.
|
Controls
n=21602 Participants
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.
|
|---|---|---|
|
Risk of Depressive Episodes Within Adult Patients With Vitiligo
|
157 Participants
|
501 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Cases
n=7224 Participants
Patients with a confirmed diagnosis of Vitiligo within the study period will be included as cases for analysis.
|
Controls
n=28880 Participants
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.
|
|---|---|---|
|
Number of Participants With Anxiety Disorder
|
569 Participants
|
2031 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Cases
n=7224 Participants
Patients with a confirmed diagnosis of Vitiligo within the study period will be included as cases for analysis.
|
Controls
n=28880 Participants
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.
|
|---|---|---|
|
Number of Participants With Recurrent Depressive Disorder
|
1093 Participants
|
4305 Participants
|
PRIMARY outcome
Timeframe: Within two years of vitiligo diagnosis. For matched controls, within two years of the date of diagnosis of their matched case.Population: Patients with a pre-existing diagnosis of anxiety disorder were excluded from the analysis
Adjusted hazard ratio calclulated using Cox Proportional hazard models
Outcome measures
| Measure |
Cases
n=6655 Participants
Patients with a confirmed diagnosis of Vitiligo within the study period will be included as cases for analysis.
|
Controls
n=24834 Participants
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.
|
|---|---|---|
|
Risk of Anxiety Disorder Within Adult Patients With Vitiligo
|
122 Participants
|
382 Participants
|
PRIMARY outcome
Timeframe: Within two years of vitiligo diagnosis. For matched controls, within two years of the date of diagnosis of their matched case.Population: Patients with a pre-existing diagnosis of recurrent depressive disorder were excluded from the analysis
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).
Outcome measures
| Measure |
Cases
n=6131 Participants
Patients with a confirmed diagnosis of Vitiligo within the study period will be included as cases for analysis.
|
Controls
n=21091 Participants
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.
|
|---|---|---|
|
Risk of Recurrent Depressive Disorder Within Adult Patients With Vitilgo
|
113 Participants
|
312 Participants
|
Adverse Events
Cases
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place