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临床试验/NCT07424911
NCT07424911已完成不适用

α-N-acetylgalactosaminidase Levels in Panic Disorder: A Prospective Observational Cohort Study

Elazığ Mental Health and Diseases Hospital1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2025年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
66
试验地点
1
主要终点
α-N-acetylgalactosaminidase

研究概览

简要总结

This prospective observational cohort study investigated serum α-N-acetylgalactosaminidase levels in drug-naïve patients with Panic Disorder (PD) at baseline and after six weeks of follow-up and compared them with healthy controls (HC). Associations between enzyme levels, symptom severity, and inflammatory markers were examined. The study aimed to evaluate whether α-N-acetylgalactosaminidase levels are associated with PD symptom severity and inflammatory parameters.

详细描述

Panic Disorder (PD) is associated with increased inflammatory markers. α-N-acetylgalactosaminidase mediates deglycosylation of vitamin D-binding protein (Gc protein), affecting macrophage activation and immune regulation. Its role in anxiety disorders has not been previously examined.

Thirty-three drug-naïve patients with PD and 33 healthy controls (HC) were enrolled. Patients with PD were evaluated at baseline and after six weeks of standard clinical treatment. Serum α-N-acetylgalactosaminidase levels were measured using ELISA. DSM-5 Panic Disorder Scale (PDS) scores and complete blood count inflammatory parameters were recorded.

No intervention was assigned as part of the research protocol. Participants received routine clinical care.

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

入选标准

  • For Panic Disorder (PD) Group:
  • Inclusion Criteria:
  • Age ≥18 years and <65 years
  • Diagnosis of PD according to DSM-5-TR
  • Drug-naïve at baseline

排除标准

  • Age <18 years and >65 years
  • Any psychiatric diagnosis other than PD
  • Active alcohol or substance use disorder
  • Significant medical illness
  • Incomplete follow-up
  • For Healthy Control (HC) Group:
  • Inclusion Criteria:
  • Age ≥18 years and <65 years
  • Exclusion Criteria:
  • Age <18 years and >65 years
  • Any psychiatric diagnosis
  • Active alcohol or substance use disorder
  • Significant medical illness

研究组 & 干预措施

Panic Disorder (PD)

Drug-naïve adult participants (18-65 years) diagnosed with Panic Disorder according to DSM-5-TR criteria. Participants were evaluated at baseline and after 6 weeks of routine clinical treatment. No intervention was assigned by the study protocol. Blood samples were collected for measurement of serum α-N-acetylgalactosaminidase levels and inflammatory parameters. Clinical symptom severity was assessed using the DSM-5 Panic Disorder Scale (PDS).

干预措施: No intervention was assigned as part of the research protocol. (Other)

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 α-N-acetylgalactosaminidase levels and complete blood count inflammatory markers.

干预措施: No intervention was assigned as part of the research protocol. (Other)

结局指标

主要结局

α-N-acetylgalactosaminidase

时间窗: Baseline and 6 weeks

Serum α-N-acetylgalactosaminidase levels measured by ELISA (ng/mL).

次要结局

  • DSM-5 Panic Disorder Scale (PDS) Score(Baseline and 6 weeks)
  • Logistic regression prediction of PD diagnosis(Baseline)
  • α-N-acetylgalactosaminidase and neutrophil count correlation(Baseline)
  • α-N-acetylgalactosaminidase and neutrophil count association(Baseline)

研究者

发起方
Elazığ Mental Health and Diseases Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Mehmet Hamdi ÖRÜM

Associate Professor

Elazığ Mental Health and Diseases Hospital

研究点 (1)

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