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NCT Number: NCT07432815

Treatment of Psoriasis With Depression and/or Anxiety With Methotrexate vs Combined Methotrexate and Antidepressant

This randomized controlled trial aims to compare the efficacy of methotrexate (MTX) monotherapy versus combined methotrexate and selective serotonin reuptake inhibitor (SSRI) therapy in patients with psoriasis and comorbid depression and/or anxiety. Participants will be randomly assigned to two groups: one receiving MTX alone and the other receiving MTX plus escitalopram. Clinical outcomes will be evaluated over a 6-month period, including psoriasis severity using the Psoriasis Area and Severity Index (PASI) and Body Surface Area (BSA), quality of life using the Dermatology Life Quality Index (DLQI), and psychological status using the Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Hamilton Depression Rating Scale (HAM-D), and Hamilton Anxiety Rating Scale (HAM-A). The study will assess whether combination therapy provides superior clinical and psychological outcomes.

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Key information

Conditions

Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Mental Disorders Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kasralainy

Cairo, Cairo Governorate, 11562, Egypt

Location status: Recruiting

Location contact

Kasralainy Medical Kasralainy psoriasis unit

CONTACT

[email protected]

02 23643524

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Combination of methotrexate and escitalopram in treatment of psoriasis patients with depression and/or anxiety

Combination Product

Combination of methotrexate and escitalopram in treatment of psoriasis patients with depression and/or anxiety

methotrexate

Drug

Methotrexate 0.4mg/kg once weekly for 6 months

Primary outcomes

  1. comparison of Percentage change in PASI score from baseline to 6 months between group A and B

    Time frame: 6 months

  2. Comparison between percentage change of BDI, BAI, Ham-A and Ham-D in groups A&B

    Time frame: 6 months

  3. Comparison of percentage of patients who achieved PASI 75%, 90% & 100% between groups A & B

    Time frame: 6 months

Study contacts

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

Naglaa Mohsen, Resident

CONTACT

[email protected]

+201026838866

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 25, 2026
Registry last updated
May 5, 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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