Potential Intervention Strategy With Folic Acid and Vitamin B12 in Patients With Schizophrenia

Taipei Medical University WanFang Hospital88 enrolled

Overview

The investigators study aims are: 1. To investigate folate, vitamin B12, and homocysteine levels in patients with schizophrenia. 2. To evaluate the relationships among folate, vitamin B12, and homocysteine levels, genetic variants of one-carbon cycle pathway, psychopathology, including positive symptoms, negative symptoms, and cognition, and metabolic abnormalities in patients with schizophrenia. 3. For patients with low folate levels, the investigators would like to conduct a 24-week double-blinded, placebo-controlled of folic acid (5 mg/d) and vitamin B12 (500 ug/d) supplementation study to know whether combination of folic acid and vitamin B12 can improve patients' psychopathology or metabolic profiles, and the effects of genetic variants in one-carbon cycle pathway on treatment response.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Schizophrenia

Interventions

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 20-65 year-old. 2. Fulfill DSM-IV-TR diagnosis of schizophrenia. 3. Be treated with an antipsychotic agent for at least 6 months or at a stable dose for at least 3 months. 4. Patients with folate deficiency or insufficiency, and PANSS score at least 60 or more in the first phase screening. Folate deficiency and insufficiency (low folate level) are defined as serum folate \< 6.8 nmol/L (3 ng/mL) and \<= 13.5 nmol/L (6 ng/mL), respectively. Exclusion Criteria: 1. Medically unstable. 2. Currently taking vitamin supplementation. 3. Pregnancy or lactation. 4. Test positive of urine drug screen 5. Megaloblastic anemia due to folate deficiency; 6. Patients with parkinsonism (score of \> 12 on the Simpson-Angus Scale); 7. History of alcohol or other substances use disorder in past 3 months; 8. History of significant neurological illness; 9. Creatine\>1.4 ng/dl.

Outcomes

Primary Outcomes

Positive and Negative Syndrome Scale (PANSS)

We used PANSS to evaluate patients' psychopathology at baseline, week-2, 4, 8, 12, 16, 20, and 24.

Time frame: 24 weeks

Secondary Outcomes

CogStat neuropsychological test, including speed of processing, attention, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition

CogStat will be used to test patients' cognitive function, including speed of processing, attention, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition, at baseline and week-24.

Time frame: 24 weeks

blood pressure, mmHg

Blood pressure will be checked at week 4, 12, and 24.

Time frame: 24 weeks

waist circumference, cm

Waist circumference will be checked at week 4, 12, and 24.

Time frame: 24 weeks

triglyceride, mg/dL

Triglyceride will be checked at week 4, 12, and 24.

Time frame: 24 weeks

high density lipoprotein cholesterol (HDL-C), mg/dL

HDL-C will be checked at week 4, 12, and 24.

Time frame: 24 weeks

fasting blood sugar level, mg/dL

fasting blood sugar level will be checked at week 4, 12, and 24.

Time frame: 24 weeks

Potential Intervention Strategy With Folic Acid and Vitamin B12 in Patients With Schizophrenia

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts