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NCT Number: NCT07424911

α-N-acetylgalactosaminidase Levels in Panic Disorder

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.

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Key information

Conditions

Panic Disorder Anxiety Disorders Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mehmet Hamdi ÖRÜM

Elâzığ, 23200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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
  • 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

Treatment and study plan

No intervention was assigned as part of the research protocol.

Other

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.

Primary outcomes

  1. α-N-acetylgalactosaminidase

    Time frame: Baseline and 6 weeks

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

Secondary outcomes

  1. DSM-5 Panic Disorder Scale (PDS) Score

    Time frame: Baseline and 6 weeks

    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.

  2. α-N-acetylgalactosaminidase and neutrophil count correlation

    Time frame: Baseline

    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.

  3. Logistic regression prediction of PD diagnosis

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

Elazığ Mental Health and Diseases Hospital

Other Gov

Registry information

Official study title

α-N-acetylgalactosaminidase Levels in Panic Disorder: A Prospective Observational Cohort Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 20, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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