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

Sponsor
Cairo University
Study ID
NCT07432815
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

First listed
Feb 25, 2026
Start date
Feb 1, 2026
Status verified
Apr 2026
Primary completion
Dec 1, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Methotrxate only
    Methotrexate 0.4mg/kg for 6 months in psoriasis patients
  • Experimental: Methotrexate and SSRI
    Methotrexate 0.4mg/kg and escitalopram 10mg for 6 months in psoriasis patients

Primary Outcome Measure

comparison of Percentage change in PASI score from baseline to 6 months between group A and B [ Time Frame: 6 months ]

Central Contacts

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