α-N-acetylgalactosaminidase Levels in Panic Disorder

NCT07424911 | Completed DMC

• 1 other identifier: EMHDH-2025-PD-NAGALASE-01
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Panic Disorder

Keywords

Panic disorder; α-N-acetylgalactosaminidase; Nagalase; Macrophage-activating factor; Vitamin D-binding protein

Outcome Measures

Primary Outcomes (1)

• α-N-acetylgalactosaminidase

  Serum α-N-acetylgalactosaminidase levels measured by ELISA (ng/mL).

  Baseline and 6 weeks

Secondary Outcomes (3)

• DSM-5 Panic Disorder Scale (PDS) Score

  Baseline and 6 weeks

• α-N-acetylgalactosaminidase and neutrophil count association

  Baseline

• Logistic regression prediction of PD diagnosis

  Baseline

Study Arms (2)

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. 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. Participants with PD received routine clinical care.

Interventions

No intervention was assigned as part of the research protocol. Participants with PD received routine clinical care. OTHER

No intervention was assigned as part of the research protocol. Participants with PD received routine clinical care.

Healthy Control (HC); Panic Disorder (PD)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Elazığ Mental Health and Diseases Hospital: lead

Study Sites (1)

Mehmet Hamdi ÖRÜM

Elâzığ, 23200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Panic Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Mehmet Hamdi ÖRÜM, MD

  Elazığ Mental Health and Diseases Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: February 20, 2026
• Study Start: May 1, 2025
• Primary Completion: June 16, 2025
• Study Completion: August 1, 2025
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• 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

TU (1)