Treatment of Psoriasis With Depression and/or Anxiety With Methotrexate vs Combined Methotrexate and Antidepressant
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 depression
Started Feb 2026
Shorter than P25 for phase_4 depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2026
CompletedFirst Submitted
Initial submission to the registry
February 18, 2026
CompletedFirst Posted
Study publicly available on registry
February 25, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2026
May 5, 2026
April 1, 2026
10 months
February 18, 2026
April 29, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
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
Study Arms (2)
Methotrxate only
ACTIVE COMPARATORMethotrexate 0.4mg/kg for 6 months in psoriasis patients
Methotrexate and SSRI
EXPERIMENTALMethotrexate 0.4mg/kg and escitalopram 10mg for 6 months in psoriasis patients
Interventions
Combination of methotrexate and escitalopram in treatment of psoriasis patients with depression and/or anxiety
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Kasralainy
Cairo, Cairo Governorate, 11562, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident
Study Record Dates
First Submitted
February 18, 2026
First Posted
February 25, 2026
Study Start
February 1, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 30, 2026
Last Updated
May 5, 2026
Record last verified: 2026-04