NCT07444879

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 7, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 3, 2026

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2026

Completed
Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

9 months

First QC Date

February 25, 2026

Last Update Submit

March 2, 2026

Conditions

Keywords

Panic DisorderInterleukin-33IL-33Soluble Suppressor Tumorogenicity-2sST2CRPC-Reactive Protein

Outcome Measures

Primary Outcomes (3)

  • Interleukin-33 (IL-33)

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

    At hospital admission (baseline)

  • Soluble Suppressor Tumorogenicity-2 (sST2)

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

    At hospital admission (baseline)

  • C-Reactive Protein (CRP)

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

    At hospital admission (baseline)

Secondary Outcomes (2)

  • Aggregate Index of Systemic Inflammation (AISI)

    At hospital admission (baseline)

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

    At hospital admission (baseline)

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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:

You may not qualify if:

  • 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:
  • 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
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elazığ Mental Health and Diseases Hospital Psychiatry Clinic

Elâzığ, Elâzığ, 23200, Turkey (Türkiye)

RECRUITING

Related Publications (6)

  • 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.

    PMID: 35194013BACKGROUND
  • 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.

    PMID: 24581826BACKGROUND
  • 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.

    PMID: 34908836BACKGROUND
  • 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.

    PMID: 25092610BACKGROUND
  • 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.

    PMID: 31693974BACKGROUND
  • 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.

    PMID: 22608631BACKGROUND

MeSH Terms

Conditions

Panic Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Central Study Contacts

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

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Assoc. Prof, Psychiatrist

Study Record Dates

First Submitted

February 25, 2026

First Posted

March 3, 2026

Study Start

July 7, 2025

Primary Completion

March 23, 2026

Study Completion

March 23, 2026

Last Updated

March 4, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
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.

Locations