The Impact of Dupilumab Treatment on Anxiety and Depression Symptoms in Patients With Moderate-to-Severe Atopic Dermatitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dupilumab.
- Who it may be relevant to
- Registry conditions: Atopic Dermatitis. Basic parameters: from 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Qatar, Saudi Arabia, United Arab Emirates
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Impact of Dupilumab Treatment on Anxiety and Depression Symptoms in Patients With Moderate-to-Severe Atopic Dermatitis in Gulf Countries
Overview
This study aims to assess the impact of dupilumab on the mental health and quality of life of moderate-to-severe Atopic Dermatitis (AD) patients. The study will recruit participants from AD patients who are already receiving dupilumab treatment. The study enrollment period will be about 9 months with each of the participants undergoing a 6-month observational study period.
Interventions
- Drug Dupilumab
This study will not administer any treatment, only observe the treatment as prescribed in real world clinical practice.
Primary outcome measures
- Proportion of Participants with Hospital Anxiety and Depression Scale Anxiety (HADS-A) Sub-scores of Less Than 8 [Time frame: Week 24]
- Proportion of Participants with HADS Depression (HADS-D) Sub-scores of less than 8 [Time frame: Week 24]
- Change from Baseline in HADS Total Score. [Time frame: Baseline to up to Week 24]
- Proportion of Participants with More Than or Equal to 4-point Improvement in POEM Total Score [Time frame: Week 24]
- Change from Baseline in POEM Total Score. [Time frame: Baseline to up to Week 24]
Secondary outcome measures (4)
- Change from Baseline in Dermatology Life Quality Index (DLQI)/Children's DLQI total score. [Time frame: Baseline to week 24]
- Proportion of Participants Achieving More than Equal to 4-point Improvement in DLQI/CDLQI Minimal Clinically Important Difference (MCID) [Time frame: Week 24]
- Proportion of Participants with Impacted Psychological Status using Dermatological Cumulative Life Course Impairment-Prospective (DermCLCI-p) [Time frame: Baseline to up to Week 24]
- Proportion of Participants with Impacted Professional Life/Education Status using DermCLCI-p [Time frame: At Baseline and Week 24.]
Eligibility criteria
Inclusion criteria
- Participants who have moderate to severe AD with signs and symptoms of anxiety and/or depression.
- Participants who initiate dupilumab therapy within 30 days of enrolment, based on the treating physician's decision, independently of study participation
- Participants and/or their legally approved representatives (LAR in case of the minor subject) must agree to sign an informed consent or an assent.
Exclusion criteria
- Females who are pregnant, lactating, or planning/intending to be pregnant in the next 6 months.
- Participants who are participating in another trial.
- Participants with active chronic or acute infection requiring systemic treatment.
- Participants who are diagnosed with active endoparasite infection or are suspected of being at high risk of infection.
- Participants with human immunodeficiency virus (HIV), hepatitis B or C, malignancy, or other concomitant illnesses.
- Participants on antidepressants/anti-anxiety within 6 months of enrolment or those who are planning to receive antidepressants/anti-anxiety. In addition, those who will use antidepressants/anti-anxiety medications throughout the study will be excluded from the analysis.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United Arab Emirates · 4 centers
- Investigational Site: NMC Specialty Hospital LTD — Abu Dhabi
- Investigational Site: Dibba Hospital — Fujairah
- Investigational Site: Ibrahem Bin Hamad Hospital — Ras al-Khaimah
- Investigational Site: Al Qassimi Hospital — Sharjah city
Saudi Arabia · 2 centers
- Investigational Site: Saudi Medical Services (Medical Fakeeh) — Jeddah
- Investigational Site: King Faisal Specialist Hospital — Jeddah
Qatar · 1 center
- Investigational Site: Hamad Medical Corporation — Doha
Identifiers
NCT: NCT07467564 · OBS18647 · U1111-1316-0051