Treatment of Psoriasis With Depression and/or Anxiety With Methotrexate vs Combined Methotrexate and Antidepressant
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Combination of methotrexate and escitalopram in treatment of psoriasis patients with depression and/or anxiety, Methotrexate.
- Who it may be relevant to
- Registry conditions: Depression, Anxiety, Psoriasis. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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 product Combination 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 - Drug Methotrexate
Methotrexate 0.4mg/kg once weekly for 6 months
Primary outcome measures
- comparison of Percentage change in PASI score from baseline to 6 months between group A and B [Time frame: 6 months]
- Comparison between percentage change of BDI, BAI, Ham-A and Ham-D in groups A&B [Time frame: 6 months]
- Comparison of percentage of patients who achieved PASI 75%, 90% & 100% between groups A & B [Time frame: 6 months]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Kasralainy — Cairo
Identifiers
NCT: NCT07432815 · MS-98-2025