drugset / Trial / NCT07432815

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

NCT07432815

Phase 4 Recruiting 40 enrolled Cairo University
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2026-02-01
Primary completion
2026-12-01
Completion
2026-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Escitalopram Small molecule 10 mg
Comparator Methotrexate Small molecule 0.4 mg/kg