Neuroinflammation and Affective and Cognitive Symptoms in Patients Suffering From Major Depression and Psoriasis and Their Evolution With Treatment: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Correlation between immunological markers and affective and cognitive symptoms at baseline.
研究概览
简要总结
Objectives: To identify peripheral neuroinflammatory markers in patients suffering from major depression or psoriasis in relation to affective symptoms (anxiety, depression, irritability), fatigue and cognitive symptoms; and their change after specific treatments.
Methodology: Observational prospective cohort study in patients diagnosed with major depression and patients with plaque psoriasis, who naturalistically undergo different treatments (systemic or biological for psoriasis, antidepressants for depression). Forty-one patients with major depression attending psychiatric consultations and 82 patients with psoriasis attending dermatology consultations at Hospital Universitari Germans Trias i Pujol aged 18 to 65 years old will be selected for inclusion. All of them will be assessed at baseline and after 4 months treatment through a series of demographic and clinical variables, psychiatric diagnosis, psychopathological scales and immunological and biochemical variables after blood draw for obtaining serum, peripheral blood mononuclear cell (PBMC) and extraction of total RNA. Investigators will analyze the correlation between immunological markers and affective and cognitive symptoms at baseline, as well as their variation after treatment. Subsequently, a bivariate comparative analysis will be carried out, where statistically significant or marginally significant variables associated with psychopathological variables will be used to construct a multivariate model of binary logistic regression.
详细描述
Design This is a prospective observational study of cohorts with patients diagnosed with major depression or psoriasis and subjected to different treatments with systemic or biological drugs in the case of psoriasis, and with antidepressants in the case of major depression.
Subjects of study The subjects that will participate in this study will be outpatients treated in the Dermatology Consultations and the Psychiatric Consultations of the Germans Trias i Pujol University Hospital (Badalona, Spain), clinically diagnosed with psoriasis or major depression.
Inclusion criteria:
- Age between 18 and 65
- Clinical diagnosis of 1) In the psoriasis group: diagnosis of plaque psoriasis made by a dermatologist, lasting at least 6 months; 2) In the major depression group: clinical diagnosis of major depression according to DSM-5 criteria made by a psychiatrist.
- Patients receiving systemic or biological treatment for psoriasis, or antidepressant for major depression.
Exclusion criteria:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65
- •Clinical diagnosis of:
- •In the psoriasis group: diagnosis of plaque psoriasis made by a dermatologist, lasting at least 6 months.
- •In the major depression group: clinical diagnosis of major depression according to DSM-5 criteria made by a psychiatrist.
- •Patients receiving systemic or biological treatment for psoriasis, or antidepressant for major depression.
- •Exclusion criteria:
- •Previous treatments for psoriasis
- •UVBBE phototherapy in the last 2 weeks
- •PUVA phototherapy in the last 4 weeks
- •Conventional systemic treatments in the last 4 weeks
- •Biological treatments in the last 3 months
- •Previous antidepressant treatments in the last 6 weeks
- •Antipsychotic or eutimizing treatments in the last 6 weeks
- •The presence of concurrent psychotic symptoms
- •Alcohol or drug use disorders, with active consumption during the last 3 months
- •Pregnant women
- •Serious and / or unstable medical disorders, Addison or Cushing's disease, Rheumatoid arthritis or systemic lupus erythematosus.
排除标准
- 未提供
结局指标
主要结局
Correlation between immunological markers and affective and cognitive symptoms at baseline.
时间窗: Baseline
To evaluate the relationship of psychiatric symptoms (affective symptoms, fatigue, cognitive deficits) and markers of inflammation, HPA axis, oxidative and nitrosative stress, gliosis and neurogenesis in both groups of psoriasic and depressive patients.
Changes in immunological markers and affective and cognitive symptoms between baseline and after 4 months of treatment.
时间窗: Baseline and at 4 months
To evaluate the changes of psychiatric symptoms (affective symptoms, fatigue, cognitive deficits) and markers of inflammation, HPA axis, oxidative and nitrosative stress, gliosis and neurogenesis, after treatment for psoriasis with systemic or biological treatment of psoriasis and with antidepressant treatment for major depression.
次要结局
- Correlation between immunological markers and the course of psychiatric comorbidity in relation to anti-inflammatory treatments(Baseline and at 4 months)
- Correlation between the course of major depression with antidepressant treatment and biomarkers of inflammation(Baseline and at 4 months)