α-N-acetylgalactosaminidase in Schizoaffective Disorder

NCT07673718 | Completed DMC

• 1 other identifier: EMHDH-2025-SAD-NAGALASE-01
• Study Type: observational
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

Schizoaffective disorder (SAD) is a severe psychiatric condition characterized by the coexistence of psychotic symptoms and mood episodes. Growing evidence suggests that immune dysregulation and inflammatory processes contribute to the pathophysiology of schizophrenia-spectrum disorders, including SAD. α-N-acetylgalactosaminidase is a lysosomal enzyme involved in glycoprotein metabolism and immune regulation through its effects on Gc protein-derived macrophage activating factor. Previous studies have reported altered α-N-acetylgalactosaminidase levels in schizophrenia and bipolar disorder; however, its role in SAD has not been investigated. The aim of this cross-sectional study is to compare serum α-N-acetylgalactosaminidase levels among patients with SAD during acute exacerbation and remission phases and healthy controls. The study also examines the relationships between α-N-acetylgalactosaminidase levels, symptom severity, and systemic inflammation. Clinical assessments include the Positive and Negative Syndrome Scale, Young Mania Rating Scale, Beck Depression Inventory, and Global Assessment Scale. Systemic inflammation is evaluated using the Aggregate Index of Systemic Inflammation, derived from routine complete blood count parameters. By investigating the association of α-N-acetylgalactosaminidase with clinical and inflammatory features of SAD, this study seeks to improve understanding of the biological mechanisms underlying the disorder and to explore the potential utility of α-N-acetylgalactosaminidase as a biomarker related to disease state and symptom severity.

Conditions

Schizoaffective Disorder

Keywords

Schizoaffective Disorder; α-N-acetylgalactosaminidase; Healthy Control; Biomarker

Outcome Measures

Primary Outcomes (1)

• α-N-acetylgalactosaminidase

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

  At hospital admission (baseline)

Secondary Outcomes (5)

• Aggregate Index of Systemic Inflammation (AISI)

  At hospital admission (baseline)

• Positive and Negative Syndrome Scale (PANSS) Score

  At hospital admission (baseline)

• Young Mania Rating Scale (YMRS)

  At hospital admission (baseline)

• Beck Depression Inventory (BDI)

  At hospital admission (baseline)

• Global Assessment Scale (GAS)

  At hospital admission (baseline)

Study Arms (2)

Schizoaffective Disorder (SAD)

Adult participants (18-65 years) with schizoaffective disorder according to Diagnostic and Statistical Manual of Mental Disorders 5th Text Revision Edition criteria. There were two subgroups: Participants with SAD during acute exacerbation (SAD-AE), participants with SAD in remission (SAD-R). Participants were evaluated at baseline. No intervention was assigned by the study protocol. Blood samples were collected for the measurement of serum α-N-acetylgalactosaminidase levels and complete blood count parameters. Clinical assessments in the SAD group included the Positive and Negative Syndrome Scale (PANSS) for psychotic symptom severity, the Young Mania Rating Scale (YMRS) for manic symptom severity, the Beck Depression Inventory (BDI) for depressive symptom severity, and Global Assessment Scale (GAS) for global functioning. Sociodemographic and clinical data 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 α-N-acetylgalactosaminidase levels and complete blood count inflammatory markers. Sociodemographic and clinical data were recorded for all participants.

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 will consist of adult participants aged 18-65 years. The schizoaffective disorder (SAD) group will include consecutive subjects diagnosed with SAD according to DSM-5-TR criteria who will be admitted to the psychiatry clinic of Elazığ Mental Health and Diseases Hospital (Turkey). The healthy control (HC) group will consist of individuals from the general population who will apply to the hospital medical board and will have no current or past psychiatric or significant medical disorders. All participants will provide informed consent prior to enrollment.

You may qualify if:

• Diagnosis of SAD according to DSM-5-TR
• Acute exacerbation episode or remission phase
• Medication-free for at least one month prior to admission for acute exacerbation episode and regular medication use for remission use
• Age ≥ 18 years and \<65 years
• Provided informed consent
• For Schizoaffective Disorder (SAD) Group:

You may not qualify if:

• Hypertension
• Diabetes mellitus
• Chronic kidney disease
• Rheumatoid arthritis
• Systemic lupus erythematosus
• Cardiac illness
• Severe neurological disorders
• Immunological or systemic illness
• Primary psychiatric disorders other than SAD
• Alcohol/drug/substance use
• For Healthy Control Group:
• No psychiatric diagnosis
• No systemic or immunological illness
• Medication-free for at least one month
• Age ≥ 18 years and \< 65 years

Sponsors & Collaborators

• Elazığ Mental Health and Diseases Hospital: lead

Study Sites (1)

Elazığ Mental Health and Diseases Hospital Psychiatry Clinic

Elâzığ, Elâzığ, 23200, Turkey (Türkiye)

Location

Related Publications (5)

• Yilmaz S, Oner P. Low alpha-N-acetylgalactosaminidase plasma concentration correlates with the presence and severity of the bipolar affective disorder. World J Biol Psychiatry. 2023 Feb;24(2):187-194. doi: 10.1080/15622975.2022.2124451. Epub 2022 Sep 27.

  PMID: 36102137 BACKGROUND

• 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.

  PMID: 35521802 BACKGROUND

• Sakuraba H, Matsuzawa F, Aikawa SI, Doi H, Kotani M, Nakada H, Fukushige T, Kanzaki T. Structural and immunocytochemical studies on alpha-N-acetylgalactosaminidase deficiency (Schindler/Kanzaki disease). J Hum Genet. 2004;49(1):1-8. doi: 10.1007/s10038-003-0098-z. Epub 2003 Dec 19.

  PMID: 14685826 BACKGROUND

• Nagasawa H, Uto Y, Sasaki H, Okamura N, Murakami A, Kubo S, Kirk KL, Hori H. Gc protein (vitamin D-binding protein): Gc genotyping and GcMAF precursor activity. Anticancer Res. 2005 Nov-Dec;25(6A):3689-95.

  PMID: 16302727 BACKGROUND

• Malik S, Fu L, Juras DJ, Karmali M, Wong BY, Gozdzik A, Cole DE. Common variants of the vitamin D binding protein gene and adverse health outcomes. Crit Rev Clin Lab Sci. 2013 Jan-Feb;50(1):1-22. doi: 10.3109/10408363.2012.750262. Epub 2013 Feb 22.

  PMID: 23427793 BACKGROUND

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, MD, Psychiatrist

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: June 29, 2026
• Study Start: April 25, 2025
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: June 29, 2026

Record last verified: 2026-06

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)