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

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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07432815

Enrollment

Registered

2026-02-25

Start date

2026-02-01

Completion date

2026-12-30

Last updated

2026-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression, Psoriasis

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.

Interventions

COMBINATION_PRODUCTCombination of methotrexate and escitalopram in treatment of psoriasis patients with depression and/or anxiety

Combination of methotrexate and escitalopram in treatment of psoriasis patients with depression and/or anxiety

DRUGMethotrexate

Methotrexate 0.4mg/kg once weekly for 6 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
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

Countries

Egypt

Contacts

CONTACTNaglaa Mohsen, Resident

n.mohssen96@gmail.com+201026838866

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 6, 2026