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CompletedNCT07444879Updated Oct 26, 2026

IL-33, sST2, and CRP in Panic Disorder

An observational study in Panic Disorder, sponsored by Elazığ Mental Health and Diseases Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by Elazığ Mental Health and Diseases Hospital · Observational

Updated Oct 26, 2026Eligibility revisedGo to Updates ↓
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
71
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

Read the detailed description

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 will be collected as 5 mL. 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.

02

Conditions studied

  • Panic Disorder

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Keywords

  • Panic Disorder
  • Interleukin-33
  • IL-33
  • Soluble Suppressor Tumorogenicity-2
  • sST2
  • CRP
  • C-Reactive Protein
03

In context

Panic Disorder

270 studies on the registry are indexed under Panic Disorder; 37 are open to participants now.

This study's enrollment of 71 is below the median of 200 across 50 observational studies indexed under Panic Disorder.

Browse Panic Disorder studies →

Lead sponsor

Elazığ Mental Health and Diseases Hospital is the lead sponsor of 13 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Oct 26, 2026. See what changed

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The study population consisted of adult participants aged 18-65 years. The panic disorder (PD) group included consecutive subjects diagnosed with PD according to DSM-5-TR criteria who were admitted to the psychiatry clinic of Elazığ Mental Health and Diseases Hospital (Turkey). The healthy control (HC) group consisted of individuals from the general population who applied to the hospital medical board and had no current or past psychiatric or significant medical disorders. All participants provided informed consent prior to enrollment.

Eligibility criteria

  1. For Panic Disorder (PD) Group:

    *Inclusion Criteria:

    • Being between 18-65 years of age
    • Having a diagnosis of panic disorder (PD) according to 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, 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
    • Taking any medication or supplement in the last month
    • Incomplete completion of sociodemographic and scale data
    • Not volunteering to participate in the study
  2. 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
    • Taking any medication or supplement in the last month
    • Incomplete completion of sociodemographic and scale data
    • Not volunteering to participate in the study
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
71 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Interleukin-33 (IL-33)

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

    Time frame: At hospital admission (baseline)

  2. Soluble Suppressor Tumorogenicity-2 (sST2)

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

    Time frame: At hospital admission (baseline)

  3. C-Reactive Protein (CRP)

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

    Time frame: At hospital admission (baseline)

Secondary outcomes

  1. Systemic Inflammation Response Index (SIRI)

    SIRI was calculated as (neutrophil count × monocyte count)/lymphocyte count. Laboratory staff were blinded to group status.

    Time frame: At hospital admission (baseline)

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

    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.

    Time frame: At hospital admission (baseline)

07

Study locations

1 site
  • Elazığ Mental Health and Diseases Hospital Psychiatry Clinic
    Elâzığ, Elâzığ 23200, Turkey (Türkiye)
08

References and documents

Publications

  • Quagliato LA, Nardi AE. Cytokine profile in drug-naive panic disorder patients. Transl Psychiatry. 2022 Feb 22;12(1):75. doi: 10.1038/s41398-022-01835-y. PubMed 35194013 ↗
  • Barbosa IG, Morato IB, de Miranda AS, Bauer ME, Soares JC, Teixeira AL. A preliminary report of increased plasma levels of IL-33 in bipolar disorder: further evidence of pro-inflammatory status. J Affect Disord. 2014 Mar;157:41-4. doi: 10.1016/j.jad.2013.12.042. Epub 2014 Jan 11. PubMed 24581826 ↗
  • Liu CH, Hua N, Yang HY. Alterations in Peripheral C-Reactive Protein and Inflammatory Cytokine Levels in Patients with Panic Disorder: A Systematic Review and Meta-Analysis. Neuropsychiatr Dis Treat. 2021 Dec 7;17:3539-3558. doi: 10.2147/NDT.S340388. eCollection 2021. PubMed 34908836 ↗
  • Wieck A, Grassi-Oliveira R, do Prado CH, Rizzo LB, de Oliveira AS, Kommers-Molina J, Viola TW, Marciano Vieira EL, Teixeira AL, Bauer ME. Pro-inflammatory cytokines and soluble receptors in response to acute psychosocial stress: differential reactivity in bipolar disorder. Neurosci Lett. 2014 Sep 19;580:17-21. doi: 10.1016/j.neulet.2014.07.040. Epub 2014 Aug 1. PubMed 25092610 ↗
  • Brunoni AR, Supasitthumrong T, Teixeira AL, Vieira EL, Gattaz WF, Bensenor IM, Lotufo PA, Lafer B, Berk M, Carvalho AF, Maes M. Differences in the immune-inflammatory profiles of unipolar and bipolar depression. J Affect Disord. 2020 Feb 1;262:8-15. doi: 10.1016/j.jad.2019.10.037. Epub 2019 Oct 30. PubMed 31693974 ↗
  • Hoppe LJ, Ipser J, Gorman JM, Stein DJ. Panic disorder. Handb Clin Neurol. 2012;106:363-74. doi: 10.1016/B978-0-444-52002-9.00020-6. No abstract available. PubMed 22608631 ↗

Individual participant data

Plan to share: Yes — Deidentified individual participant data (IPD) underlying the results reported in this study (including demographic variables, serum interleukin-33 (IL-33) and soluble suppressor tumorogenicity-2 (sST2) and C-reactive protein (CRP) levels, complete blood count parameters, and DSM-5 Panic Disorder Severity Scale-Adult Form (PDS) will be made available to qualified researchers upon reasonable request for academic purposes. Data will be shared after removal of all direct identifiers and in accordance with applicable ethical approvals and data protection regulations. Access to the data will require a methodologically sound research proposal and a data use agreement. Requests should be directed to the corresponding author.

Supporting information: Study protocol

Time frame: Data will be available beginning 6 months after publication and will remain available for 5 years.

Access criteria: Access will be granted to researchers who provide a methodologically sound proposal. Requests must be approved by the principal investigator and may require a data use agreement in accordance with institutional and ethical regulations.

09

Updates

1 registry update since Sep 25, 2026
Eligibility
1 criterion edited, 2 removed
What changed in the criteria
  • RemovedPatients with a body mass index (BMI) <18.5 kg/m² and >29.9 kg/m²
  • Edited*Inclusion Criteria:
  • RemovedPatients with a body mass index (BMI) < 18.5 kg/m² and > 29.9 kg/m²
Oct 26, 2026
Secondary outcomes
1 edited
What changed in the outcomes
  • EditedAggregate Index of Systemic Inflammation Response Index (AISISIRI)Time frame: At hospital admission (baseline)
Oct 26, 2026
Show all 1 update
  1. Oct 26, 2026
    Eligibility 1 criterion edited, 2 removed
    What changed in the criteria
    • RemovedPatients with a body mass index (BMI) <18.5 kg/m² and >29.9 kg/m²
    • Edited*Inclusion Criteria:
    • RemovedPatients with a body mass index (BMI) < 18.5 kg/m² and > 29.9 kg/m²
    Secondary outcomes 1 edited
    What changed in the outcomes
    • EditedAggregate Index of Systemic Inflammation Response Index (AISISIRI)Time frame: At hospital admission (baseline)
    + 2 other changes: verification date and description

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07444879
Lead sponsor
Elazığ Mental Health and Diseases Hospital
Responsible party
Mehmet Hamdi ÖRÜM (MD, Assoc. Prof, Psychiatrist, Elazığ Mental Health and Diseases Hospital) — Principal investigator
First posted
Mar 3, 2026
Start date
Jul 7, 2025
Primary completion
Mar 5, 2026
Completion
Mar 5, 2026
Last update
Oct 26, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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