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Treatment of Psoriasis With Depression and/or Anxiety With Methotrexate vs Combined Methotrexate and Antidepressant

StatusCompleted
PhasePhase 4
Started
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Record History

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  1. Primary endpoints: details revised at 2 of 3 entries Show 6 more changesShow less
    • Trial completed
    • Primary completion date changed from estimate of Dec 1, 2026 to Jun 1, 2026
    • Study completion date changed from estimate of Dec 30, 2026 to Jun 14, 2026
    • Interventions: Combination of methotrexate and escitalopram in treatment of psoriasis patients with depression and/or anxiety (Combination Product)… to Combination of methotrexate and escitalopram in treatment of psoriasis patients with depression and/or anxiety (Combination Product)…
    • Eligibility criteria expanded, about 9 words
    • Site details revised
  2. Primary completion pushed from Dec 1, 2025 to Dec 1, 2026v2 Show 5 more changesShow less
    • Start date: Feb 1, 2025 to Feb 1, 2026
    • Study completion pushed from Dec 30, 2025 to Dec 30, 2026
    • Trial status: Completed to Recruiting
    • Interventions: Combination of methotrexate and escitalopram in treatment of psoarisis patients with depression and/or anxiety (Combination Product)… to Combination of methotrexate and escitalopram in treatment of psoriasis patients with depression and/or anxiety (Combination Product)…
    • Site details revised
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Cairo University
1,562 trials monitored
See 18 trials at risk
Anxiety
3,263 trials monitored
See 159 trials at risk
Depression
3,055 trials monitored
See 173 trials at risk
Psoriasis
591 trials monitored
See 24 trials at risk
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.
Trial Details
NCT Number NCT07432815
Lead Sponsor Cairo University
Conditions
(from sponsor)		 Depression, Anxiety, Psoriasis
Related terms Anxiety Disorders, Depression, Psoriasis
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov