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Treatment of Psoriasis With Depression and/or Anxiety With Methotrexate vs Combined Methotrexate and Antidepressant
NCT07432815 · Cairo University
In plain English
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Official title
Treatment of Psoriasis With Depression and/or Anxiety With Methotrexate vs Combined Methotrexate and Antidepressant, A Randomized Controlled Trial
About this study
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.
Eligibility criteria
Inclusion Criteria:
* Adults aged \>18 and \<60 years
* Moderate to severe psoriasis (PASI ≥10 or BSA ≥10%)
* Moderate to severe depression (BDI ≥20 or HAM-D ≥17) and/or moderate to severe anxiety (BAI ≥16 or HAM-A ≥25)
Exclusion Criteria:
* Current substance abuse
* Systemic psoriasis treatment within the past 3 months
* Pregnancy or breastfeeding
* Hypersensitivity to methotrexate or escitalopram
* Erythrodermic or pustular psoriasis
* Contraindications to methotrexate (e.g., hepatic disease or malignancy)
Study design
Enrollment target: 40 participants
Allocation: randomized
Masking: none
Age groups: adult
Timeline
Starts: 2026-02-01
Estimated completion: 2026-12-30
Last updated: 2026-05-05
Interventions
Combination Product: Combination of methotrexate and escitalopram in treatment of psoriasis patients with depression and/or anxietyDrug: Methotrexate
Primary outcomes
- • 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)
Sponsor
Cairo University · other
Contacts & investigators
ContactNaglaa Mohsen, Resident · contact · n.mohssen96@gmail.com · +201026838866
All locations (1)
KasralainyRecruiting
Cairo, Cairo Governorate, Egypt