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Study on the Role and Mechanism of Folic Acid in Cognitive Dysfunction of Patients with Schizophrenia with Low Folic Acid Levels

Study on the Role and Mechanism of Folic Acid in Cognitive Dysfunction of Patients with Schizophrenia with Low Folic Acid Levels

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600117041
Enrollment
Unknown
Registered
2026-01-19
Start date
2026-01-19
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

schizophrenia

Interventions

Research Group:Atypical antipsychotic drugs + oral folic acid, 15mg per day, for 24 weeks of treatment
control group:Monotherapy with Atypical antipsychotic drugs for 12 weeks
then Atypical antipsychotic drugs + oral folic acid, 15mg per day, for 12 weeks

Sponsors

The First Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Inpatients with schizophrenia who have met the ICD-10 diagnostic criteria and whose first episode or recurrence occurred within the past 3 months and who have not received antipsychotic medication treatment; 2. Age 18-60 years old, gender not limited; 3. Folate 179 pmol/ml); 4. Education level of junior high school or above, able to understand and cooperate with the C-BCT examination; 5.No continuous use of antibiotics for more than 3 days in the past 3 months; 6. 17.5 <= Body Mass Index (BMI) <= 30; 7. Good family support, able to understand and comply with the research requirements; 8. Regular diet, without special dietary habits.

Exclusion criteria

Exclusion criteria: 1. Patients with organic brain diseases, mental retardation, digestive tract diseases, pernicious anemia, epilepsy, and severe systemic diseases are excluded; (Liver function abnormality: Aspartate aminotransferase (AST) >= 2×ULN (normal upper limit); or Alanine aminotransferase (ALT) >= 2×ULN; Renal function abnormality: Creatinine (Cr) >= 1.5×ULN; Blood sugar abnormality: Fasting blood glucose >= 7.0 mmol/L; Lipid abnormality: Fasting total cholesterol > 5.5 mmol/L, or fasting triglycerides > 1.6 mmol/L) 2. Patients with substance abuse or dependence as diagnosed according to ICD-10 criteria and not completely relieved are excluded. The patient's condition is judged to meet the criteria for substance abuse or dependence as diagnosed by ICD-10 based on the medical history.

Design outcomes

Primary

MeasureTime frame
Chinese simplified version of the Neurocognitive Assessment Battery(C-BCT);Positive and Negative Syndrome Scale;

Secondary

MeasureTime frame
folic acid;Vitamin B12;Homocysteine;Inflammatory factors;Oxidative stress-related indicators;

Countries

China

Contacts

Public ContactGuo Liyang

The First Affiliated Hospital of Xi'an Jiaotong University

guo109@126.com+86 153 9906 9762

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026