Methotrexate alone versus methotrexate plus escitalopram for people with psoriasis and depression or anxiety

Treatment of Psoriasis With Depression and/or Anxiety With Methotrexate vs Combined Methotrexate and Antidepressant, A Randomized Controlled Trial

This tests whether adding the antidepressant escitalopram to methotrexate helps adults with moderate-to-severe psoriasis who also have depression or anxiety.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Cairo University (Academic / other)
• Drugs / interventions: methotrexate
• Locations: 1 site (Cairo, Cairo Governorate)
• Trial ID: NCT07432815 on ClinicalTrials.gov

What this trial studies

This randomized, open-label phase 4 trial will assign adults with moderate-to-severe psoriasis and moderate-to-severe depression and/or anxiety to receive either methotrexate alone or methotrexate plus escitalopram. Participants will be followed for six months with regular clinical visits. Skin outcomes (PASI, BSA) and quality of life (DLQI) will be tracked alongside standardized mood measures (BDI, BAI, HAM-D, HAM-A). The trial tests whether combined therapy yields superior dermatologic and psychological improvement compared with methotrexate monotherapy.

Who should consider this trial

Good fit: Adults 18–60 with moderate-to-severe psoriasis (PASI ≥10 or BSA ≥10%) and moderate-to-severe depression (BDI ≥20 or HAM-D ≥17) and/or anxiety (BAI ≥16 or HAM-A ≥25) who are not pregnant or breastfeeding and have no contraindications to methotrexate or escitalopram.

Not a fit: People with mild psoriasis or mild mood symptoms, those with erythrodermic or pustular psoriasis, current substance abuse, recent systemic psoriasis treatment, pregnancy/breastfeeding, or contraindications to methotrexate/escitalopram are unlikely to benefit from this combined therapy.

Why it matters

Potential benefit: If successful, adding escitalopram to methotrexate could improve both skin disease and mood symptoms, improving overall quality of life.

How similar studies have performed: Some small studies and biological rationale suggest SSRIs can influence inflammation and improve mood, but large randomized trials testing SSRIs added to methotrexate for psoriasis with comorbid depression/anxiety are limited.

Eligibility criteria

Inclusion Criteria:

* Adults aged \>18 and \<60 years
* Moderate to severe psoriasis (PASI ≥10 or BSA ≥10%)
* Moderate to severe depression (BDI ≥20 or HAM-D ≥17) and/or moderate to severe anxiety (BAI ≥16 or HAM-A ≥25)

Exclusion Criteria:

* Current substance abuse
* Systemic psoriasis treatment within the past 3 months
* Pregnancy or breastfeeding
* Hypersensitivity to methotrexate or escitalopram
* Erythrodermic or pustular psoriasis
* Contraindications to methotrexate (e.g., hepatic disease or malignancy)

Where this trial is running

Cairo, Cairo Governorate

• Kasralainy — Cairo, Cairo Governorate, Egypt (Recruiting)

Study contacts

• Study coordinator: Naglaa Mohsen, Resident

Conditions Depression; Anxiety; Psoriasis