NCT07432815 Treatment of Psoriasis With Depression and/or Anxiety With Methotrexate vs Combined Methotrexate and Antidepressant
| NCT ID | NCT07432815 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Cairo University |
| Condition | Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-02-01 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 40 participants in total. It began in 2026-02-01 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07432815 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07432815 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07432815 currently recruiting?
Yes, NCT07432815 is actively recruiting participants. Contact the research team at n.mohssen96@gmail.com for enrollment information.
Where is the NCT07432815 trial being conducted?
This trial is being conducted at Cairo, Egypt.
Who is sponsoring the NCT07432815 clinical trial?
NCT07432815 is sponsored by Cairo University. The trial plans to enroll 40 participants.
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