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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methotrxate only | Active Comparator | Methotrexate 0.4mg/kg for 6 months in psoriasis patients |
|
| Methotrexate and SSRI | Experimental | Methotrexate 0.4mg/kg and escitalopram 10mg for 6 months in psoriasis patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combination of methotrexate and escitalopram in treatment of psoriasis patients with depression and/or anxiety | Combination Product | Combination of methotrexate and escitalopram in treatment of psoriasis patients with depression and/or anxiety |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Naglaa Mohsen, Resident | Contact | +201026838866 | n.mohssen96@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kasralainy | Recruiting | Cairo | Cairo Governorate | 11562 | Egypt |
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| Methotrexate | Drug | Methotrexate 0.4mg/kg once weekly for 6 months |
|
| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000089983 | Escitalopram |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
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