Treatment of Psoriasis With Depression and/or Anxiety With Methotrexate vs Combined Methotrexate and Antidepressant
NCT07432815 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-05-05
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
Interventions
- COMBINATION_PRODUCT
-
Combination of methotrexate and escitalopram in treatment of psoriasis patients with depression and/or anxiety
Combination of methotrexate and escitalopram in treatment of psoriasis patients with depression and/or anxiety
- DRUG
-
Methotrexate 0.4mg/kg once weekly for 6 months
Sponsors & Collaborators
-
Cairo University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-02-01
- Primary Completion
- 2026-12-01
- Completion
- 2026-12-30
Countries
- Egypt
Study Locations
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