DepressionPhase 4NCT07432815
Treatment of Psoriasis With Depression and/or Anxiety With Methotrexate vs Combined Methotrexate and Antidepressant
A Phase 4 study testing Combination of methotrexate and escitalopram in treatment of psoriasis patients with depression and/or anxiety and Methotrexate in people with Depression and Anxiety, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Depression, Anxiety, Psoriasis
- What is being tested?
- Combination of methotrexate and escitalopram in treatment of psoriasis patients with depression and/or anxiety and Methotrexate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2026to 14 Jun 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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 and contacts
1 site in 1 country.
About this study
Official title: Treatment of Psoriasis With Depression and/or Anxiety With Methotrexate vs Combined Methotrexate and Antidepressant, A Randomized Controlled Trial
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.
- Conditions
- Depression, Anxiety, Psoriasis
- Being tested
- Combination of methotrexate and escitalopram in treatment of psoriasis patients with depression and/or anxiety, Methotrexate
- Medical subject headings
- Depression, Anxiety Disorders, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of methotrexate and escitalopram in treatment of psoriasis patients with depression and/or anxietyCombination product
Combination of methotrexate and escitalopram in treatment of psoriasis patients with depression and/or anxiety
MethotrexateDrug
Methotrexate 0.4mg/kg once weekly for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Methotrxate only | Active comparator | Methotrexate 0.4mg/kg for 6 months in psoriasis patients Receives: Drug: Methotrexate |
| Methotrexate and SSRI | Experimental | Methotrexate 0.4mg/kg and escitalopram 10mg for 6 months in psoriasis patients Receives: Combination Product: Combination of methotrexate and escitalopram in treatment of psoriasis patients with depression and/or anxiety |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of Percentage change in PASI score from baseline to 6 months between group A and B
Measured: 6 months
Comparison between percentage change of BDI, BAI, Ham-A and Ham-D in groups A&B
Measured: 6 months
Comparison of percentage of patients who achieved PASI 75%, 90% & 100% between groups A & B
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start1 Feb 2026
- Primary completion1 Jun 2026
- Study completion14 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naglaa Mohsen Hussien, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07432815
- Sponsor's protocol ID
- MS-98-2025
- Status last verified
- Oct 2026
- First submitted
- 18 Feb 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Psoriasis With Depression and/or Anxiety With Methotrexate vs Combined Methotrexate and Antidepressant, A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07432815
- Acronym / sponsor ID
- MS-98-2025
- Conditions
- Depression, Anxiety, Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 14 Jun 2026 (actual)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methotrxate only | Active comparator | Drug: MethotrexateMethotrexate 0.4mg/kg for 6 months in psoriasis patients |
| Methotrexate and SSRI | Experimental | Combination Product: Combination of methotrexate and escitalopram in treatment of psoriasis patients with depression and/or anxietyMethotrexate 0.4mg/kg and escitalopram 10mg for 6 months in psoriasis patients |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- Current substance abuse
- Systemic psoriasis treatment within the past 3 months
- Pregnancy or breastfeeding
- Hypersensitivity to methotrexate or escitalopram
- Erythrodermic or pustular psoriasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combination of methotrexate and escitalopram in treatment of psoriasis patients with depression and/or anxietyCombination of methotrexate and escitalopram in treatment of psoriasis patients with depression and/or anxiety | Combination product | Methotrexate and SSRI |
| MethotrexateMethotrexate 0.4mg/kg once weekly for 6 months | Drug | Methotrxate only |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Combination of methotrexate and escitalopram in treatment of psoriasis patients with depression and/or anxiety and Methotrexate in people with Depression and Anxiety, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of Percentage change in PASI score from baseline to 6 months between group A and B (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.