Schizophrenia
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTfolic acid 5 mg/cap
the intervention includes folic acid 5 mg/d and vitamin B12 500 ug/d
OTHERPlacebo
placebo
Sponsors
Taipei Medical University WanFang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive and Negative Syndrome Scale (PANSS) | 24 weeks | We used PANSS to evaluate patients' psychopathology at baseline, week-2, 4, 8, 12, 16, 20, and 24. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| blood pressure, mmHg | 24 weeks | Blood pressure will be checked at week 4, 12, and 24. |
| waist circumference, cm | 24 weeks | Waist circumference will be checked at week 4, 12, and 24. |
| CogStat neuropsychological test, including speed of processing, attention, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition | 24 weeks | 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. |
| high density lipoprotein cholesterol (HDL-C), mg/dL | 24 weeks | HDL-C will be checked at week 4, 12, and 24. |
| fasting blood sugar level, mg/dL | 24 weeks | fasting blood sugar level will be checked at week 4, 12, and 24. |
| triglyceride, mg/dL | 24 weeks | Triglyceride will be checked at week 4, 12, and 24. |
Countries
Taiwan
Contacts
Primary ContactChun-Hsin Chen, MD
Outcome results
None listed