Treatment of Psoriasis With Depression and/or Anxiety With Methotrexate vs Combined Methotrexate and Antidepressant, A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- comparison of Percentage change in PASI score from baseline to 6 months between group A and B
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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)
研究组 & 干预措施
Methotrxate only
Methotrexate 0.4mg/kg for 6 months in psoriasis patients
干预措施: Methotrexate (Drug)
Methotrexate and SSRI
Methotrexate 0.4mg/kg and escitalopram 10mg for 6 months in psoriasis patients
干预措施: Combination of methotrexate and escitalopram in treatment of psoriasis patients with depression and/or anxiety (Combination Product)
结局指标
主要结局
comparison of Percentage change in PASI score from baseline to 6 months between group A and B
时间窗: 6 months
Comparison between percentage change of BDI, BAI, Ham-A and Ham-D in groups A&B
时间窗: 6 months
Comparison of percentage of patients who achieved PASI 75%, 90% & 100% between groups A & B
时间窗: 6 months
次要结局
未报告次要终点
研究者
Naglaa Mohsen Hussien
Resident
Cairo University