α-N-acetylgalactosaminidase Levels in Panic Disorder

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.

Study Overview

• Status: Completed
• Conditions: Panic Disorder
• Intervention / Treatment: Other: No intervention was assigned as part of the research protocol.

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 Type: Observational
• Enrollment (Actual): 66

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Elâzığ
    • Elâzığ, Elâzığ, Turkey (Türkiye), 23200
      • Mehmet Hamdi ÖRÜM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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.

Description

1. For Panic Disorder (PD) Group:

   • Inclusion Criteria:

     • Age ≥18 years and <65 years
     • Diagnosis of PD according to DSM-5-TR
     • Drug-naïve at baseline

   • Exclusion Criteria:

     • Age <18 years and >65 years
     • Any psychiatric diagnosis other than PD
     • Active alcohol or substance use disorder
     • Significant medical illness
     • Incomplete follow-up

2. For Healthy Control (HC) Group:

   • Inclusion Criteria:

     • Age ≥18 years and <65 years

   • Exclusion Criteria:

     • Age <18 years and >65 years
     • Any psychiatric diagnosis
     • Active alcohol or substance use disorder
     • Significant medical illness

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	Other: No intervention was assigned as part of the research protocol.; No intervention was assigned as part of the research protocol.; Other Names: No intervention was assigned as part of the research protocol. Participants with PD received routine clinical care.
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.	Other: No intervention was assigned as part of the research protocol.; No intervention was assigned as part of the research protocol.; Other Names: No intervention was assigned as part of the research protocol. Participants with PD received routine clinical care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
α-N-acetylgalactosaminidase	Serum α-N-acetylgalactosaminidase levels measured by ELISA (ng/mL).	Baseline and 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline

Collaborators and Investigators

• Sponsor: Elazığ Mental Health and Diseases Hospital
• Investigators: Principal Investigator: Mehmet Hamdi ÖRÜM, MD, Elazığ Mental Health and Diseases Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• Zoga 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Actual): June 16, 2025
• Study Completion (Actual): August 1, 2025

Study Registration Dates

• First Submitted: February 13, 2026
• First Submitted That Met QC Criteria: February 13, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): June 29, 2026
• Last Update Submitted That Met QC Criteria: June 24, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Panic disorder; Nagalase; α-N-acetylgalactosaminidase; Macrophage-activating factor; Vitamin D-binding protein
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Panic Disorder
• Other Study ID Numbers: EMHDH-2025-PD-NAGALASE-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: Data will be available beginning 6 months after publication and will remain available for 5 years.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No