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NCT Number: NCT07444879

IL-33, sST2, and CRP in Panic Disorder

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Elazığ Mental Health and Diseases Hospital Psychiatry Clinic

Elâzığ, 23200, Turkey (Türkiye)

Location status: Recruiting

Location contact

Mehmet Hamdi ÖRÜM, MD, Assoc. Prof., Psychiatrist

CONTACT

[email protected]

+905382207558

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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:

*Exclusion Criteria:

  • 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

Treatment and study plan

Primary outcomes

  1. Interleukin-33 (IL-33)

    Time frame: At hospital admission (baseline)

    Interleukin-33 (IL-33) levels measured by ELISA (pg/ml).

  2. Soluble Suppressor Tumorogenicity-2 (sST2)

    Time frame: At hospital admission (baseline)

    Soluble Suppressor Tumorogenicity-2 (sST2) levels measured by ELISA (pg/ml)

  3. C-Reactive Protein (CRP)

    Time frame: At hospital admission (baseline)

    C-Reactive Protein (CRP) levels measured by ELISA (mg/dL)

Secondary outcomes

  1. Aggregate Index of Systemic Inflammation (AISI)

    Time frame: At hospital admission (baseline)

    Aggregate Index of Systemic Inflammation (AISI) is calculated using the following formula: (neutrophils × monocytes × platelets) / (lymphocytes). All the parameters mentioned here are complete blood count parameters.

  2. DSM-5 Panic Disorder Severity Scale-Adult Form (PDS)

    Time frame: At hospital admission (baseline)

    The DSM-5 Panic Disorder Severity Scale-Adult Form (PDS) is a 10-item self-assessment scale developed by the American Psychiatric Association (APA) that uses a five-point Likert scale (0=Never; 1=Sometimes; 2=Halfway through; 3=Most of the time; 4=Always). Participants consider how much their panic disorder has affected their personal lives in the past seven days when completing the scale. Scores obtained from the scale items indicate the severity of the panic disorder. The scale can be scored between 0 and 40, with higher scores indicating a more severe panic disorder. The mean total score is calculated by dividing the total raw score by the number of items on the scale.

Study contacts

Contact information is provided by the study sponsor or research team.

Mehmet Hamdi ÖRÜM, MD, Ass. Prof., Psychiatrist

CONTACT

[email protected]

+905382207558

Sponsors and collaborators

Lead sponsor

Elazığ Mental Health and Diseases Hospital

Other Gov

Registry information

Official study title

Investigation of IL-33, sST2, and C-Reactive Protein in Panic Disorder: A Cross-Sectional Case-Control Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 3, 2026
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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