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

Trial compares methotrexate alone vs. with antidepressant for psoriasis with depression/anxiety

NCT: NCT07432815 · Status: COMPLETED · Phase: Phase 4 · Sponsor: Cairo University · Started: 2025-02-01 · Est. Completion: 2025-12-30

Plain English Summary

Treatment of Psoriasis With Depression and/or Anxiety With Methotrexate vs Combined Methotrexate and Antidepressant is a Phase 4 clinical trial sponsored by Cairo University studying Depression, Anxiety, Psoriasis. Tests if adding an antidepressant to methotrexate works better than methotrexate alone for people with psoriasis and depression/anxiety. This trial is for adults aged 18-60 with moderate to severe psoriasis and moderate to severe depression and/or anxiety. Participants will be randomly assigned to receive either methotrexate alone or methotrexate plus an antidepressant (escitalopram) for 6 months. Alternative treatments may include other systemic psoriasis medications or psychotherapy for depression/anxiety. The trial aims to enroll 40 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you are an adult between 18 and 60 years old. You must have moderate to severe psoriasis and moderate to severe depression and/or anxiety. You cannot join if you have current substance abuse, are pregnant or breastfeeding, or have certain types of psoriasis (erythrodermic or pustular). You also cannot join if you have liver disease, cancer, or are allergic to methotrexate or escitalopram, or have recently used other systemic psoriasis treatments. This trial is studying Depression, Anxiety, Psoriasis, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcomes measure how much the psoriasis skin condition and the symptoms of depression and anxiety improve over 6 months in each treatment group, indicating which approach is more effective The specific primary outcome measures are: 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). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This is a Phase 4 (post-marketing) study of a treatment that has already received FDA approval. Phase 4 trials monitor long-term safety, effectiveness in broader patient populations, and potential interactions with other treatments in real-world settings. These studies can involve thousands of patients and help identify rare side effects that may not have appeared in earlier, smaller trials.

Why This Trial Matters

This trial addresses the unmet need for effective treatments that manage both the skin symptoms of psoriasis and the psychological distress of depression and anxiety often experienced by patients. This research targets Depression, Anxiety, Psoriasis, where improved treatment options are needed.

Investor Insight

This trial explores a combination therapy for a common comorbidity, potentially expanding treatment options and market share for both psoriasis and mental health medications. This treatment is already approved and on the market. This post-marketing study monitors real-world outcomes.

Is This Trial Right for Me?

Ask your doctor about the potential benefits and risks of methotrexate and escitalopram. Understand that you will be randomly assigned to one of two treatment groups and will receive either methotrexate alone or methotrexate plus escitalopram for 6 months. You will need to attend regular appointments for check-ups and assessments of your skin, mood, and anxiety levels. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Full 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)

Trial Locations

Frequently Asked Questions

What is clinical trial NCT07432815?

NCT07432815 is a Phase 4 INTERVENTIONAL study titled "Treatment of Psoriasis With Depression and/or Anxiety With Methotrexate vs Combined Methotrexate and Antidepressant." It is currently completed and is sponsored by Cairo University. The trial targets enrollment of 40 participants.

What conditions does NCT07432815 study?

This trial investigates treatments for Depression, Anxiety, Psoriasis. The primary condition under study is Depression.

What treatments are being tested in NCT07432815?

The interventions being studied include: Combination of methotrexate and escitalopram in treatment of psoarisis patients with depression and/or anxiety (COMBINATION_PRODUCT), Methotrexate (DRUG). Combination of methotrexate and escitalopram in treatment of psoarisis patients with depression and/or anxiety

What does Phase 4 mean for NCT07432815?

Phase 4 trials occur after a treatment is already approved and on the market. They monitor long-term effectiveness and safety in larger populations under real-world conditions.

What is the current status of NCT07432815?

This trial is currently "Completed." It started on 2025-02-01. The estimated completion date is 2025-12-30.

Who is sponsoring NCT07432815?

NCT07432815 is sponsored by Cairo University. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT07432815?

The trial aims to enroll 40 participants. The trial status is completed.

How is NCT07432815 designed?

This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.

What are the primary outcomes being measured in NCT07432815?

The primary outcome measures are: 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). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT07432815 being conducted?

This trial is being conducted at 1 site, including Cairo (Egypt).

Where can I find official information about NCT07432815?

The official record for NCT07432815 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07432815. This government database provides the most up-to-date and detailed information about the trial.

What is NCT07432815 testing in simple terms?

Tests if adding an antidepressant to methotrexate works better than methotrexate alone for people with psoriasis and depression/anxiety. This trial is for adults aged 18-60 with moderate to severe psoriasis and moderate to severe depression and/or anxiety.

Why is this trial significant?

This trial addresses the unmet need for effective treatments that manage both the skin symptoms of psoriasis and the psychological distress of depression and anxiety often experienced by patients.

What are the potential risks of participating in NCT07432815?

Common side effects of methotrexate can include nausea, fatigue, and mouth sores. Potential side effects of escitalopram may include dizziness, insomnia, or sexual dysfunction. There is a risk of liver problems with methotrexate and other side effects specific to each medication. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT07432815?

Ask your doctor about the potential benefits and risks of methotrexate and escitalopram. Understand that you will be randomly assigned to one of two treatment groups and will receive either methotrexate alone or methotrexate plus escitalopram for 6 months. You will need to attend regular appointments for check-ups and assessments of your skin, mood, and anxiety levels. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT07432815 signal from an investment perspective?

This trial explores a combination therapy for a common comorbidity, potentially expanding treatment options and market share for both psoriasis and mental health medications. This is a Phase 4 trial, which is in early development stages.

What happens if the treatment in this trial doesn't work?

Participants will be randomly assigned to receive either methotrexate alone or methotrexate plus an antidepressant (escitalopram) for 6 months. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.