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NCT Number: NCT07467564

The Impact of Dupilumab Treatment on Anxiety and Depression Symptoms in Patients With Moderate-to-Severe Atopic Dermatitis

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Investigational Site: Hamad Medical Corporation, Doha, Qatar

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dupilumab

Drug

This study will not administer any treatment, only observe the treatment as prescribed in real world clinical practice.

Primary outcomes

  1. Proportion of Participants with Hospital Anxiety and Depression Scale Anxiety (HADS-A) Sub-scores of Less Than 8

    Time frame: Week 24

    The HADS is a 14-item patient-reported outcomes measure used to assess states of anxiety and depression over the past week. It is comprised of 7 items assessing anxiety and depression respectively. A Total score is out of 42 (21 per subscale). Higher scores indicate greater levels of anxiety.

  2. Proportion of Participants with HADS Depression (HADS-D) Sub-scores of less than 8

    Time frame: Week 24

    The HADS is a 14-item patient-reported outcomes measure used to assess states of anxiety and depression over the past week. It is comprised of 7 items assessing anxiety and depression respectively. A Total score is out of 42 (21 per subscale). Higher scores indicate greater levels of depression.

  3. Change from Baseline in HADS Total Score.

    Time frame: Baseline to up to Week 24

    The HADS is a 14-item patient-reported outcomes measure used to assess states of anxiety and depression over the past week. It is comprised of 7 items assessing anxiety and depression respectively. A Total score is out of 42 (21 per subscale). Higher scores indicate greater levels of anxiety and/or depression.

  4. Proportion of Participants with More Than or Equal to 4-point Improvement in POEM Total Score

    Time frame: Week 24

    The Patient Oriented Eczema Measure (POEM) is a 7-item self-assessment questionnaire that assesses disease symptoms on a scale ranging from 0 to 4 (0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, 4 = all days). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). Higher scores indicate more severe disease and poor quality of life.

  5. Change from Baseline in POEM Total Score.

    Time frame: Baseline to up to Week 24

    The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms on a scale ranging from 0 to 4 (0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, 4 = all days). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). Higher scores indicate more severe disease and poor quality of life.

Secondary outcomes

  1. Change from Baseline in Dermatology Life Quality Index (DLQI)/Children's DLQI total score.

    Time frame: Baseline to week 24

    DLQI is a 10-item questionnaire to measure dermatology specific quality of life (QoL). The DLQI is designed for use in adults (patients more than equal to [≥] 17 years of age) and the CDLQI for patients 12-17 years of age. Each question is scored on a four-point Likert scale. The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. A score higher than 10 indicates that the patient's life is being severely affected by their skin disease.

  2. Proportion of Participants Achieving More than Equal to 4-point Improvement in DLQI/CDLQI Minimal Clinically Important Difference (MCID)

    Time frame: Week 24

    DLQI is a 10-item questionnaire to measure dermatology specific quality of life (QoL). The DLQI is designed for use in adults (patients more than equal to [≥] 17 years of age) and the CDLQI for patients 12-17 years of age. Each question is scored on a four-point Likert scale. The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. A score higher than 10 indicates that the patient's life is being severely affected by their skin disease.

  3. Proportion of Participants with Impacted Psychological Status using Dermatological Cumulative Life Course Impairment-Prospective (DermCLCI-p)

    Time frame: Baseline to up to Week 24

    DermCLCI-p is the predictive tool of 30 questions that assesses the current cumulative life course impairment (CLCI) status and future risk. This tool consists of 30 items, items 1 to 28 are answered on a 4-point Likert scale ranging from 0 (not at all) to 3 (very). Items 29 and 30 are answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very).

  4. Proportion of Participants with Impacted Professional Life/Education Status using DermCLCI-p

    Time frame: At Baseline and Week 24.

    DermCLCI-p is the predictive tool of 30 questions that assesses the current cumulative life course impairment (CLCI) status and future risk. This tool consists of 30 items, items 1 to 28 are answered on a 4-point Likert scale ranging from 0 (not at all) to 3 (very). Items 29 and 30 are answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very).

Study contacts

Contact information is provided by the study sponsor or research team.

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

[email protected]

800-633-1610 ext. option 6

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study title

The Impact of Dupilumab Treatment on Anxiety and Depression Symptoms in Patients With Moderate-to-Severe Atopic Dermatitis in Gulf Countries

Acronym: DERMIND-AD

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 12, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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