Life sciences · Phase 4 Trial
ClinicalTrials.gov · October 5, 2026
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Phase 4 Trial.
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Registry record from ClinicalTrials.gov (NCT07432815). This is a study registration, not published results. Lead sponsor: Cairo University. Recruitment status: COMPLETED. Phase: PHASE4. Study type: INTERVENTIONAL. Enrollment: 40 participants (ACTUAL). Conditions: Depression, Anxiety, Psoriasis. Interventions: COMBINATION_PRODUCT: Combination of methotrexate and escitalopram in treatment of psoriasis patients with depression and/or anxiety; DRUG: Methotrexate. Primary outcome measures: comparison of Percentage change in PASI score from baseline to 6 months between group A and B , 6 months; Comparison between percentage change of BDI, BAI, Ham-A and Ham-D in groups A&B , 6 months; Comparison of percentage of patients who achieved PASI 75%, 90% & 100% between groups A & B , 6 months. Brief 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.