Psoriasis Clinical Trials

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Treatment of Psoriasis With Depression and/or Anxiety With Methotrexate vs Combined Methotrexate and Antidepressant, A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Combination product, Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Egypt
Kasralainy
RECRUITING
Cairo
Contact Information
Primary
Naglaa Mohsen, Resident
n.mohssen96@gmail.com
+201026838866
Time Frame
Start Date: 2026-02-01
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 40
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Cairo University

This content was sourced from clinicaltrials.gov