How dupilumab affects anxiety and depression in moderate-to-severe atopic dermatitis
Observes mood and quality of life in people with atopic dermatitis taking dupilumab.
Key facts
- Who runs it
- Sanofi
- Where
- Jeddah, Saudi ArabiaSee the 2 sitesAlso in 2 other countries, 5 sites
- Trial code
- NCT07467564
- U1111-1316-0051
- Registry title
- The Impact of Dupilumab Treatment on Anxiety and Depression Symptoms in Patients With Moderate-to-Severe Atopic Dermatitis
- Status
- Recruiting
- People taking part
- 184 people, planned
- Started
- 24 Feb 2026
- Expected to end
- 24 May 2027
- Type of study
- Observational
- Treatments tested
- Dupilumab
- Record updated
- 28 July 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people with moderate to severe atopic dermatitis who also have signs of anxiety or depression and are starting dupilumab.
- Age
- 12 years and older
- Sex
- All sexes can join.
- Disease stage
- Moderate to severe atopic dermatitis, with signs and symptoms of anxiety and/or depression.
- Earlier treatment
- Must start dupilumab within 30 days of enrolment, as decided by the treating doctor. Must not have taken antidepressants or anti-anxiety medicines in the 6 months before enrolment.
Main reasons for not taking part
- Pregnant, breastfeeding, or planning pregnancy in the next 6 months
- Taking part in another trial
- Active infection needing treatment through the body (systemic treatment), or an active parasite infection or high risk of one
- HIV, hepatitis B or C, cancer, or other illnesses at the same time
- Using or planning to use antidepressants or anti-anxiety medicines
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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
- Females who are pregnant, lactating, or planning/intending to be pregnant in the next 6 months
- Participants who are participating in another trial
Where in Saudi Arabia
Also in 2 other countries, 5 sites
- Investigational Site: Saudi Medical Services (Medical Fakeeh)Jeddah, Saudi ArabiaTaking people
- Investigational Site: King Faisal Specialist HospitalJeddah, Saudi ArabiaNo longer taking part
About the trial
What the trial wants to find out
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.
Treatments tested
- Dupilumab
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The Impact of Dupilumab Treatment on Anxiety and Depression Symptoms in Patients With Moderate-to-Severe Atopic Dermatitis in Gulf Countries
- Plain-language title
- How dupilumab affects anxiety and depression in moderate-to-severe atopic dermatitisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Record updated
- 28 July 2026