Investigation of IL-33, sST2, and C-Reactive Protein in Panic Disorder: A Cross-Sectional Case-Control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- C-Reactive Protein (CRP)
研究概览
简要总结
Panic disorder (PD) is characterized by recurrent and unexpected panic attacks and is associated with significant functional impairment. Increasing evidence suggests involvement of immune-inflammatory mechanisms in PD. Elevated levels of inflammatory markers such as C-reactive protein (CRP) have been reported in PD; however, interleukin-33 (IL-33) and soluble suppressor tumorogenicity-2 (sST2), components of the IL-33/sST2 signaling axis, have not previously been investigated in PD. This cross-sectional case-control study aims to compare peripheral serum IL-33, sST2, and CRP levels between drug-naïve subjects diagnosed with PD and healthy controls (HCs). The findings may contribute to understanding the inflammatory mechanisms underlying PD.
详细描述
This is an observational, cross-sectional, case-control study conducted at the psychiatry outpatient clinic of Elazığ Mental Health and Diseases Hospital. It was planned to include 40 participants in the panic disorder (PD) and healthy controls (HCs) groups. All participants will complete a sociodemographic data form and the DSM-5 Panic Disorder Severity Scale (Adult Form). Venous blood samples (5 mL) will be collected between 08:30-10:00 a.m. after 12-hour fasting. Serum interleukin-33 (IL-33), soluble suppressor tumorogenicity-2 (sST2), and C-reactive protein (CRP) levels will be measured using commercially available ELISA kits. Statistical analyses will include independent samples t-test or Mann-Whitney U test, chi-square test, correlation, regression, and ROC analysis. A p value < 0.05 will be considered statistically significant.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
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
- 是
入选标准
- •For Panic Disorder (PD) Group:
- •*Inclusion Criteria:
- •Being between 18-65 years of age
- •Having a diagnosis of panic disorder (PD) according to DSM-5-TR and having presented to the hospital with panic attack symptoms of the disorder
- •Not having previously used any medication for psychiatric purposes (drug-naive)
- •Not having any additional active psychiatric disorders besides PD at the current presentation
- •Absence of hypertension, diabetes mellitus, renal failure, hepatic failure, neurological disease with cognitive impairment, acute infection, pregnancy, autoimmune disease, or cancer
- •Not having taken any medication or supplements in the last month
- •Completing sociodemographic and scale data fully
- •Volunteering to participate in the study
- •For PD Group:
排除标准
- •Being outside the 18-65 age range
- •Not meeting the diagnostic criteria for PD according to DSM-5-TR or being in good health
- •Having a history of psychiatric medication use
- •Having an additional psychiatric disorder besides PD at the current application
- •Presence of hypertension, diabetes mellitus, renal failure, hepatic failure, neurological disease with cognitive impairment, acute infection, pregnancy, autoimmune disease, cancer
- •Patients with a body mass index (BMI) <18.5 kg/m² and >29.9 kg/m²
- •Taking any medication or supplement in the last month
- •Incomplete completion of sociodemographic and scale data
- •Not volunteering to participate in the study
- •For Healthy Control Group:
- •Inclusion Criteria:
- •Being between 18-65 years of age
- •Not having any active psychiatric disorder
- •Not having previously used any medication for psychiatric purposes (drug-naive)
- •Not having hypertension, diabetes mellitus, kidney failure, liver failure, neurological disease with cognitive impairment, acute infection, pregnancy, autoimmune disease, or cancer
- •Not having taken any medication or supplement in the last month
- •Completing sociodemographic and scale data fully
- •Volunteering to participate in the study
- •For Healthy Control Group:
- •*Exclusion Criteria:
- •Being outside the 18-65 age range
- •Having any active psychiatric disorder
- •Having a history of using psychiatric medication
- •Having hypertension, diabetes mellitus, renal failure, hepatic failure, neurological disease with cognitive impairment, acute infection, pregnancy, autoimmune disease, or cancer
- •Patients with a body mass index (BMI) < 18.5 kg/m² and > 29.9 kg/m²
- •Taking any medication or supplement in the last month
- •Incomplete completion of sociodemographic and scale data
- •Not volunteering to participate in the study
研究组 & 干预措施
Panic Disorder (PD)
Adult participants (18-65 years) diagnosed with panic disorder (PD) according to DSM-5-TR criteria. All of the subjects with PD was drug-naive. Subjects were evaluated at baseline. No intervention was assigned by the study protocol. Blood samples were collected for measurement of serum interleukin-33 (IL-33) and soluble suppressor tumorogenicity-2 (sST2), and C-reactive protein (CRP) levels and complete blood count parameters. Clinical assessments in the PD group included the DSM-5 Panic Disorder Severity Scale (Adult Form). Sociodemographic and clinical data were recorded for all participants.
Healthy Control (HC)
Healthy control adult participants (18-65 years) without any current or past psychiatric disorder. No intervention was administered as part of the research protocol. Participants underwent a baseline clinical evaluation and provided a single blood sample for measurement of serum serum interleukin-33 (IL-33) and soluble suppressor tumorogenicity-2 (sST2), and C-reactive protein (CRP) levels and complete blood count parameters.
结局指标
主要结局
C-Reactive Protein (CRP)
时间窗: At hospital admission (baseline)
C-Reactive Protein (CRP) levels measured by ELISA (mg/dL)
Interleukin-33 (IL-33)
时间窗: At hospital admission (baseline)
Interleukin-33 (IL-33) levels measured by ELISA (pg/ml).
Soluble Suppressor Tumorogenicity-2 (sST2)
时间窗: At hospital admission (baseline)
Soluble Suppressor Tumorogenicity-2 (sST2) levels measured by ELISA (pg/ml)
次要结局
- Aggregate Index of Systemic Inflammation (AISI)(At hospital admission (baseline))
- DSM-5 Panic Disorder Severity Scale-Adult Form (PDS)(At hospital admission (baseline))
研究者
Mehmet Hamdi ÖRÜM
MD, Assoc. Prof, Psychiatrist
Elazığ Mental Health and Diseases Hospital