NCT07432815

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Depression
• Anxiety
• Psoriasis

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Combination of methotrexate and escitalopram in treatment of psoarisis patients with depression and/or anxiety	Combination of methotrexate and escitalopram in treatment of psoarisis patients with depression and/or anxiety
DRUG	Methotrexate	Methotrexate 0.4mg/kg once weekly for 6 months

Timeline

• Start date: 2025-02-01
• Primary completion: 2025-12-01
• Completion: 2025-12-30
• First posted: 2026-02-25
• Last updated: 2026-02-25

Locations

1 site across 1 country: Egypt