NCT07673718Completed
α-N-acetylgalactosaminidase in Schizoaffective Disorder
α-N-acetylgalactosaminidase in Acute Exacerbation and Remission Stages of Schizoaffective Disorder
Source: ClinicalTrials.gov · Last updated 29 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 93 (actual)
- First submitted
- 23 Jun 2026
- Start date
- 25 Apr 2025
- Primary completion date
- 30 Jul 2025
- Lead sponsor
- Elazığ Mental Health and Diseases Hospital
- NCT number
- NCT07673718
What you commit to
- Study type: Observational
- Participants enrolled: 93
- From 25 Apr 2025 to the primary completion date, 30 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- For Schizoaffective Disorder (SAD) Group:
- \*Inclusion Criteria:
- 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:
- \*Exclusion Criteria:
- 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:
- \*Inclusion Criteria:
- No psychiatric diagnosis
- No systemic or immunological illness
- Medication-free for at least one month
- Age ≥ 18 years and \< 65 years
- Provided informed consent
- For Healthy Control Group:
- \*Exclusion Criteria:
- Hypertension
- Diabetes mellitus
- Chronic kidney disease
- Rheumatoid arthritis
- Systemic lupus erythematosus
- Cardiac illness
- Severe neurological disorders
- Immunological or systemic illness
- Having psychiatric disorders
- Alcohol/drug/substance use
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Elazığ Mental Health and Diseases Hospital Psychiatry Clinic Coordinator of this site? Confirm its status | Elâzığ | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.