Panic DisorderNCT07424911
α-N-acetylgalactosaminidase Levels 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
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). 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
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2025to 1 Aug 2025
- 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 outpatients aged 18-65 years. The Panic Disorder (PD) group included consecutive, drug-naïve patients diagnosed with PD according to DSM-5-TR criteria who were admitted to the psychiatry outpatient 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
- Age ≥18 years and <65 years
- Diagnosis of PD according to DSM-5-TR
- Drug-naïve at baseline
- Age ≥18 years and <65 years
Who cannot join
- 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:
Show all 10Show fewer
- Age <18 years and >65 years
- Any psychiatric diagnosis
- Active alcohol or substance use disorder
- Significant medical illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: α-N-acetylgalactosaminidase Levels in Panic Disorder: A Prospective Observational Cohort Study
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.
Read the detailed description
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.
- Conditions
- Panic Disorder
- Being tested
- No intervention was assigned as part of the research protocol.
- Keywords
- Panic disorder, α-N-acetylgalactosaminidase, Nagalase, Macrophage-activating factor, Vitamin D-binding 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.
No intervention was assigned as part of the research protocol.Other
Also called No intervention was assigned as part of the research protocol. Participants with PD received routine clinical care.
No intervention was assigned as part of the research protocol.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: No intervention was assigned as part of the research protocol. | |
| 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. Receives: Other: No intervention was assigned as part of the research protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
α-N-acetylgalactosaminidase
Serum α-N-acetylgalactosaminidase levels measured by ELISA (ng/mL).
Measured: Baseline and 6 weeks
Secondary outcomes (3)
DSM-5 Panic Disorder Scale (PDS) Score
Change in DSM-5 Panic Disorder Scale (PDS) Score for Panic Disorder group (The PDS is a 10-item self-assessment scale developed by the American Psychiatric Association and provides a 5-point Likert-type rating (0=never; 1=sometimes; 2=half of the time; 3=most of the time, 4=all of the time). When completing the scale, participants consider how much Panic Disorder has affected their private lives in the last seven days. Higher scores indicate that Panic Disorder is severe.
Measured: Baseline and 6 weeks
α-N-acetylgalactosaminidase and neutrophil count correlation
In the Panic Disorder group, the correlation between serum α-N-acetylgalactosaminidase level (ng/ml) and neutrophil count (10⁶/µL), a parameter of complete blood count, was examined.
Measured: Baseline
Logistic regression prediction of PD diagnosis
Binary hierarchical logistic regression analysis was used; Model Summary: In beginning block, -2 log-likelihood=91.495; In block one, -2 log-likelihood=86.660a, Cox \& Snell R2=0.071; Nagelkerke R2 0.094, Hosmer and Lemeshov test p=0.518; In block two, -2 log-likelihood=47.497a, Cox \& Snell R2=0.487; Nagelkerke R2 0.649, Hosmer and Lemeshov test p=0.737. According to the binary logistic regression analysis, the sensitivity of our model was 78.8, and the specificity was 81.8 percent.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start1 May 2025
- Primary completion16 Jun 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 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
- Investigators
- Mehmet Hamdi ÖRÜM, MD, Principal investigator, Elazığ Mental Health and Diseases Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07424911
- Sponsor's protocol ID
- EMHDH-2025-PD-NAGALASE-01
- Status last verified
- Jun 2026
- First submitted
- 13 Feb 2026
- Last updated
- 29 Jun 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 α-N-acetylgalactosaminidase levels, complete blood count parameters, and DSM-5 Panic Disorder Scale scores at baseline and 6 weeks) 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
Yilmaz S, Oner P. Could low alpha-N-acetylgalactosaminidase plasma concentration cause schizophrenia? World J Biol Psychiatry. 2023 Jan;24(1):70-77. doi: 10.1080/15622975.2022.2070667. Epub 2022 Jun 1.
PubMed 35521802Zoga M, Nikou T, Ioannidis A, Tzavellas E, Paparrigopoulos T, Lambrokostopoulos KT, Vasdekis VG, Magana M, Chatzipanagiotou S. Alteration of alpha-N-acetylgalactosaminidase (nagalase) concentration in alcohol-dependent individuals without liver disease, during the detoxification therapy. Drug Alcohol Depend. 2017 Jan 1;170:147-151. doi: 10.1016/j.drugalcdep.2016.11.008. Epub 2016 Nov 16.
PubMed 27907862Hoppe 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 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- α-N-acetylgalactosaminidase Levels in Panic Disorder: A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07424911
- Acronym / sponsor ID
- EMHDH-2025-PD-NAGALASE-01
- Conditions
- Panic Disorder
- Keywords
- Panic disorder, α-N-acetylgalactosaminidase, Nagalase, Macrophage-activating factor, Vitamin D-binding protein
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Elazığ Mental Health and Diseases HospitalOther government
- Study start
- 1 May 2025 (actual)
- Primary completion
- 16 Jun 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 20 Feb 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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Panic Disorder (PD) | – | Other: No intervention was assigned as part of the research protocol.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). |
| Healthy Control (HC) | – | Other: No intervention was assigned as part of the research protocol.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. |
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 outpatients aged 18-65 years. The Panic Disorder (PD) group included consecutive, drug-naïve patients diagnosed with PD according to DSM-5-TR criteria who were admitted to the psychiatry outpatient 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 (4 listed)
Key exclusion criteria (10 listed)
- For Healthy Control (HC) Group:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention was assigned as part of the research protocol.Also: No intervention was assigned as part of the research protocol. Participants with PD received routine clinical care.No intervention was assigned as part of the research protocol. | Other | Healthy Control (HC), Panic Disorder (PD) |
Primary outcome
α-N-acetylgalactosaminidase
Time frame: Baseline and 6 weeks
Serum α-N-acetylgalactosaminidase levels measured by ELISA (ng/mL).
3 secondary outcomes
DSM-5 Panic Disorder Scale (PDS) Score
Time frame: Baseline and 6 weeks
α-N-acetylgalactosaminidase and neutrophil count correlation
Time frame: Baseline
Logistic regression prediction of PD diagnosis
Time frame: 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 29 Jun 2026.
- Background: PubMed 35521802Yilmaz S, Oner P. Could low alpha-N-acetylgalactosaminidase plasma concentration cause schizophrenia? World J Biol Psychiatry. 2023 Jan;24(1):70-77. doi: 10.1080/15622975.2022.2070667. Epub 2022 Jun 1.
- Background: PubMed 27907862Zoga M, Nikou T, Ioannidis A, Tzavellas E, Paparrigopoulos T, Lambrokostopoulos KT, Vasdekis VG, Magana M, Chatzipanagiotou S. Alteration of alpha-N-acetylgalactosaminidase (nagalase) concentration in alcohol-dependent individuals without liver disease, during the detoxification therapy. Drug Alcohol Depend. 2017 Jan 1;170:147-151. doi: 10.1016/j.drugalcdep.2016.11.008. Epub 2016 Nov 16.
- 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 α-N-acetylgalactosaminidase levels, complete blood count parameters, and DSM-5 Panic Disorder Scale scores at baseline and 6 weeks) 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.
Mehmet Hamdi ÖRÜM, MD principal investigator
Elazığ Mental Health and Diseases Hospital
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 4 inclusion and 10 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 29 Jun 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?
α-N-acetylgalactosaminidase (time frame: Baseline and 6 weeks). 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 NCT07424911, which also lists 3 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 29 Jun 2026.