Panic DisorderNCT07444879
IL-33, sST2, and CRP in Panic Disorder
An observational study of Panic Disorder, run by Elazığ Mental Health and Diseases Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Panic Disorder
- How many people
- 71 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Jul 2025to 5 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 17Show fewer
- Completing sociodemographic and scale data fully
- Volunteering to participate in the study
- For PD 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
- Completing sociodemographic and scale data fully
- Volunteering to participate in the study
- For Healthy Control Group:
Who cannot join
- 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
Show all 16Show fewer
- Incomplete completion of sociodemographic and scale data
- Not volunteering to participate in the study
- For Healthy Control Group:
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Elazığ Mental Health and Diseases Hospital Psychiatry Clinic
Elâzığ, Elâzığ, 23200
About this study
Official title: Investigation of IL-33, sST2, and C-Reactive Protein in Panic Disorder: A Cross-Sectional Case-Control Study
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.
- Conditions
- Panic Disorder
- Keywords
- Panic Disorder, Interleukin-33, IL-33, Soluble Suppressor Tumorogenicity-2, sST2, CRP, C-Reactive Protein
- Medical subject headings
- Panic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin-33 (IL-33)
Interleukin-33 (IL-33) levels measured by ELISA (pg/ml).
Measured: At hospital admission (baseline)
Soluble Suppressor Tumorogenicity-2 (sST2)
Soluble Suppressor Tumorogenicity-2 (sST2) levels measured by ELISA (pg/ml)
Measured: At hospital admission (baseline)
C-Reactive Protein (CRP)
C-Reactive Protein (CRP) levels measured by ELISA (mg/dL)
Measured: At hospital admission (baseline)
Secondary outcomes (2)
Systemic Inflammation Response Index (SIRI)
SIRI was calculated as (neutrophil count × monocyte count)/lymphocyte count. Laboratory staff were blinded to group status.
Measured: At hospital admission (baseline)
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.
Measured: At hospital admission (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start7 Jul 2025
- Primary completion5 Mar 2026
- Study completion5 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Panic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elazığ Mental Health and Diseases Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mehmet Hamdi ÖRÜM, Elazığ Mental Health and Diseases Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07444879
- Sponsor's protocol ID
- EMHDH-2025-2026-PD-IL33-ST2-CR
- Status last verified
- Oct 2026
- First submitted
- 25 Feb 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 35194013Barbosa 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 24581826Liu 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 34908836Wieck 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 25092610Brunoni 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 31693974Hoppe 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
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of IL-33, sST2, and C-Reactive Protein in Panic Disorder: A Cross-Sectional Case-Control Study
- ClinicalTrials.gov ID
- NCT07444879
- Acronym / sponsor ID
- EMHDH-2025-2026-PD-IL33-ST2-CR
- Conditions
- Panic Disorder
- Keywords
- Panic Disorder, Interleukin-33, IL-33, Soluble Suppressor Tumorogenicity-2, sST2, CRP, C-Reactive Protein
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Elazığ Mental Health and Diseases HospitalOther government
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- 5 Mar 2026 (actual)
- Study completion
- 5 Mar 2026 (actual)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (17 listed)
Key exclusion criteria (16 listed)
- For Healthy Control Group:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Interleukin-33 (IL-33)
Time frame: At hospital admission (baseline)
Interleukin-33 (IL-33) levels measured by ELISA (pg/ml).
Soluble Suppressor Tumorogenicity-2 (sST2)
Time frame: At hospital admission (baseline)
Soluble Suppressor Tumorogenicity-2 (sST2) levels measured by ELISA (pg/ml)
C-Reactive Protein (CRP)
Time frame: At hospital admission (baseline)
C-Reactive Protein (CRP) levels measured by ELISA (mg/dL)
2 secondary outcomes
Systemic Inflammation Response Index (SIRI)
Time frame: At hospital admission (baseline)
DSM-5 Panic Disorder Severity Scale-Adult Form (PDS)
Time frame: At hospital admission (baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Background: PubMed 35194013Quagliato 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.
- Background: PubMed 24581826Barbosa 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.
- Background: PubMed 34908836Liu 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.
- Background: PubMed 25092610Wieck 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.
- Background: PubMed 31693974Brunoni 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.
- Background: PubMed 22608631Hoppe 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Panic Disorder, run by Elazığ Mental Health and Diseases Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interleukin-33 (IL-33) (time frame: At hospital admission (baseline)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07444879, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.