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

Not Applicable

• Conditions: Schizophrenia
• Interventions: Dietary Supplement: folic acid 5 mg/cap; Other: Placebo

• Registration Number: NCT02916121
• Lead Sponsor: Taipei Medical University WanFang Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-08
• Study First Submitted: 2016-08-29
• Study First Submitted QC: 2016-09-22
• Last Update Submitted: 2016-09-22
• Study First Posted: 2016-09-27
• Last Update Posted: 2016-09-27
• Study Start: 2016-10
• Primary Completion: 2018-08
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 88

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
folic acid 5 mg/cap	folic acid 5 mg/cap	folic acid 5 mg/d and vitamin B12 500 ug/d
placebo	Placebo	placebo

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
triglyceride, mg/dL	24 weeks	Triglyceride will be checked at week 4, 12, and 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.

Trial Locations

Locations (1)

Taipei Medical University - WanFang Hospital; 🇨🇳 Taipei, Taiwan