An observational study in Alopecia Areata, Depressive Episode and Recurrent Depressive Disorder, sponsored by Momentum Data. Completed at 1 site in United Kingdom. Per ClinicalTrials.gov, last updated 2022-12-15.
Sponsored by Momentum Data · Observational
This study series consists of four related studies and aims to explore and describe many important elements of alopecia areata over three key areas: (1) the current epidemiology of alopecia areata, (2) the prevalence and incidence of psychiatric co-morbidities in people with alopecia areata, (3) the prevalence and incidence of autoimmune and atopic conditions in people with alopecia areata, and (4) the incidence of common infections in people with alopecia areata.
The overall purpose of the first study (Study 1) is to describe the epidemiology of Alopecia areata (AA) and to assess the current level of primary care service utilisation and management patterns associated with patients diagnosed with AA.
The overall purpose of the second study (study 2) is to assess the prevalence and incidence of mental health conditions (depressive episodes, recurrent depressive disorder and anxiety disorder) in adult patients diagnosed with AA relative to a control population of patients without a diagnosis of AA. In addition, the study will determine both the treatment, 'sick day' and unemployment burden. Treatment burden comprises that of medications and psychological interventions used to treat mental health conditions in adult patients diagnosed with Alopecia areata.
The overall purpose of the third study (Study 3) is to assess the prevalence and incidence of atopic and autoimmune conditions in adult patients diagnosed with AA relative to a control population of patients without AA.
The overall purpose of the fourth study (Study 4) is to assess the incidence of common infections in adult patients diagnosed with AA relative to a control population of patients without AA.
220 studies on the registry are indexed under Alopecia Areata; 61 are open to participants now.
This study's enrollment of 51,955 is above the median of 370 across 39 observational studies indexed under Alopecia Areata.
Browse Alopecia Areata studies →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.
These studies will use routinely collected and collated data from the Royal College of General Practitioners Research and Surveillance Centre database to provide a broadly representative sample of the population of England.
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Exclusion Criteria:
Patients with a confirmed diagnosis of Alopecia areata within the study period will be included as cases for analysis.
Other: Exposure of interest (studies 2 & 3).
The control cohorts will be defined by matching cases with patients who have never been diagnosed with Alopecia areata either prior to or during the study period, by age and sex, at General Practice practice level.
Other: Exposure of interest (studies 2 & 3).
Common mental health conditions consist of depressive episodes, recurrent depressive disorder and anxiety disorder Atopic conditions consist of Atopic dermatitis, allergic rhinitis, asthma Autoimmune conditions consist of Crohn's disease, ulcerative colitis, Coeliac disease, Pernicious anaemia, Type 1 diabetes, Hashimoto's thyroiditis, Grave's disease, Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Systemic lupus erythematosus, polymyalgia rheumatica, Sjögren's syndrome, Psoriasis, vitiligo, Multiple sclerosis
Study 1: The incidence of Alopecia Areata
The incidence of Alopecia areata within the study cohort during the study period
Time frame: Overall during 2009-2018 inclusive
Study 1: The incidence of Alopecia Areata stratified by sociodemographic factors
This will comprise of the incidence of Alopecia Areata over the study period, by age group, gender, ethnicity, and Social Economic Status.
Time frame: Overall during 2009-2018 inclusive
Study 1:The annual rate of primary care visits for people with Alopecia Areata.
The annual rate of visits to primary care for any reason within one year of diagnosis.
Time frame: Within one year of diagnosis of Alopecia Areata
Study 1: Secondary care dermatology service utilisation
The percent of people reviewed in secondary care dermatology services within one year of diagnosis of Alopecia Areata
Time frame: Within one year of diagnosis of Alopecia Areata
Study 2: The prevalence of common mental health conditions in adult patients diagnosed with Alopecia Areata at the time of diagnosis
Prevalence of common mental health conditions (depressive episodes, recurrent depressive disorder and anxiety disorder) in adult patients diagnosed with Alopecia Areata in a contemporary real-world population compared with matched controls.
Time frame: At the time of diagnosis in all patients diagnosed with Alopecia Areata 2009-2018 inclusive
Study 2: Describe the incidence of common mental health conditions in adult patients with Alopecia Areata
Incidence of common mental health conditions (depressive episodes, recurrent depressive disorder and anxiety disorder) in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.
Time frame: Within two years of diagnosis of Alopecia Areata
Study 2: Describe the mental health medication treatment burden of adult patients diagnosed with Alopecia Areata.
This will comprise of the number of medications used to treat mental health conditions in patients diagnoses with Alopecia Areata. Antidepressant medication classes to be examined comprise; selective serotonin reuptake inhibitors and related medications (serotonin and norepinephrine reuptake inhibitors (SNRIs)), tricyclic antidepressants and related medications (tetracyclic antidepressant), and monoamine oxidase inhibitors. Anxiolytic medications to be examined comprise all benzodiazepines and other related medications indicated for use in anxiety states.
Time frame: Within two years of diagnosis of Alopecia Areata
Study 2: Number of patients diagnosed with Alopecia Areata receiving mental health psychological intervention.
This will comprise of the number of psychological interventions used to treat mental health conditions in patients diagnoses with Alopecia Areata. Psychological interventions comprise of counselling, Cognitive Behavioural Therapy, and psychotherapy.
Time frame: Within two years of diagnosis of Alopecia Areata
Study 3: Describe the prevalence of atopic and autoimmune conditions in adult patients diagnosed with Alopecia Areata at the time of diagnosis
Prevalence of atopic and autoimmune conditions in adult patients diagnosed with Alopecia Areata in a contemporary real-world population at diagnosis compared with matched controls.
Time frame: At the time of diagnosis in all patients diagnosed with Alopecia Areata 2009-2018 inclusive
Study 3: Describe the incidence of atopic and autoimmune conditions in adult patients with Alopecia Areata.
Incidence of atopic and autoimmune conditions in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.
Time frame: Within five years of Alopecia Areata diagnosis
Study 4: The incidence of a composite of common infections in adult patients with Alopecia Areata
Incidence of a composite of any common infection (composite comprising a diagnosis of: upper and lower respiratory tract infection, pneumonia, acute bronchitis, influenza, skin infection, urinary tract infection, genital infections, gastrointestinal infection, herpes simplex and herpes zoster) in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.
Time frame: Within five years of Alopecia Areata diagnosis
Study 4: The incidence of a composite of viral infections in adult patients with Alopecia Areata
Incidence of a composite of any viral infection (composite comprising a diagnosis of: influenza, herpes simplex and herpes zoster infections, bronchitis, and any upper respiratory tract infections specifically coded as being viral) in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.
Time frame: Within five years of Alopecia Areata diagnosis
Study 1: Adjusted incidence rate ratios of Alopecia Areata within England by geographic region.
By region across England.
Time frame: Overall during 2009-2018 inclusive
Study 2: Prevalence (percentage) of common mental health conditions (depressive episodes, recurrent depressive disorder and anxiety disorder), by socio-demographic factors, in adult patients diagnosed with Alopecia Areata.
By age group, gender, ethnicity, and Social Economic Status.
Time frame: At the time of diagnosis in all patients diagnosed with Alopecia Areata 2009-2018 inclusive
Study 2: Describe the burden of 'sick days' in adult patients diagnosed with Alopecia Areata relating to mental health conditions.
Sick days will be indicated by the issuing of Med 3 certification from primary care (Statement of Fitness for Work) certification.
Time frame: Within one year of diagnosis of Alopecia Areata
Study 2: Describe the prevalence of unemployment in adult patients diagnosed with Alopecia Areata.
Unemployment will be identified using Read codes relating to unemployment recorded in the clinical record or the issuing of an Incapacity Benefit (IB113) or Employment and Support Allowance (ESA113) form.
Time frame: Within one year of diagnosis of Alopecia Areata
Study 4: The incidence of upper respiratory tract infection in adult patients with Alopecia Areata
Incidence of any recorded diagnosis of upper respiratory tract infection in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.
Time frame: Within five years of Alopecia Areata diagnosis
Study 4: The incidence of lower respiratory tract infection in adult patients with Alopecia Areata
Incidence of any recorded diagnosis of lower respiratory tract infection in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.
Time frame: Within five years of Alopecia Areata diagnosis
Study 4: The incidence of influenza infection in adult patients with Alopecia Areata
Incidence of any recorded diagnosis of influenza or influenza-like illness (where direct swab confirmed diagnosis is not performed) in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.
Time frame: Within five years of Alopecia Areata diagnosis
Study 4: The incidence of acute bronchitis in adult patients with Alopecia Areata
Incidence of any recorded diagnosis of acute bronchitis in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.
Time frame: Within five years of Alopecia Areata diagnosis
Study 4: The incidence of pneumonia in adult patients with Alopecia Areata
Incidence of any recorded diagnosis of pneumonia in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.
Time frame: Within five years of Alopecia Areata diagnosis
Study 4: The incidence of gastrointestinal infection in adult patients with Alopecia Areata
Incidence of any recorded diagnosis of gastrointestinal infection in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.
Time frame: Within five years of Alopecia Areata diagnosis
Study 4: The incidence of stool confirmed gastrointestinal infection in adult patients with Alopecia Areata
Incidence of any recorded diagnosis of gastrointestinal infection confirmed by stool culture or microscopy results (or other microbiological diagnosis confirmation) in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.
Time frame: Within five years of Alopecia Areata diagnosis
Study 4: The incidence of skin infection in adult patients with Alopecia Areata
Incidence of any recorded diagnosis of skin infection in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.
Time frame: Within five years of Alopecia Areata diagnosis
Study 4: The incidence of urinary tract infection in adult patients with Alopecia Areata
Incidence of any recorded diagnosis of urinary tract infection in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.
Time frame: Within five years of Alopecia Areata diagnosis
Study 4: The incidence of genital infection in adult patients with Alopecia Areata
Incidence of any recorded diagnosis of genital infection in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.
Time frame: Within five years of Alopecia Areata diagnosis
Study 4: The incidence of herpes zoster infection in adult patients with Alopecia Areata
Incidence of any recorded diagnosis of herpes zoster infection in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.
Time frame: Within five years of Alopecia Areata diagnosis
Study 4: The incidence of herpes simplex infection in adult patients with Alopecia Areata
Incidence of any recorded diagnosis of herpes simplex infection in adult patients with Alopecia Areata in a contemporary real-world population compared with matched controls.
Time frame: Within five years of Alopecia Areata diagnosis
Plan to share: Yes — Individual patient data is confidential but can be made available in an anonymised form to bone fide researchers subject to the required data protection training and other requirements. All data will remain behind a firewall and will only be available for access through a secured computer network.
Supporting information: Study protocol
Time frame: There is no pre-specified time-frame for data availability; this will be considered on an individual basis for each request.
Access criteria: As above
Ran from Oct 2020 to primary completion in Mar 2022, 17 months.
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This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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