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

Schizophrenia Clinical Trial

Official title:

Relationships of One-carbon Cycle Pathway With Psychopathology and Metabolic Abnormalities in Patients With Schizophrenia and Potential Intervention Strategy With Folic Acid and Vitamin B12

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02916121
• Other study ID #: 201408009
• Status: Not yet recruiting
• Phase: N/A
• First received: August 29, 2016
• Last updated: September 22, 2016
• Start date: October 2016
• Est. completion date: December 2018

Study information

• Verified date: August 2016
• Source: Taipei Medical University WanFang Hospital
• Contact: Chun-Hsin Chen, MD
• Phone: 886-970-746395
• Email: chunhsin57[@]yahoo.com.tw
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 88
• Est. completion date: December 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Dietary Supplement:
• folic acid 5 mg/cap
the intervention includes folic acid 5 mg/d and vitamin B12 500 ug/d

Other:
• Placebo
placebo

Locations

Country	Name	City	State
Taiwan	Taipei Medical University - WanFang Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University WanFang Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive and Negative Syndrome Scale (PANSS)	We used PANSS to evaluate patients' psychopathology at baseline, week-2, 4, 8, 12, 16, 20, and 24.	24 weeks	No
Secondary	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.	24 weeks	No
Secondary	blood pressure, mmHg	Blood pressure will be checked at week 4, 12, and 24.	24 weeks	No
Secondary	waist circumference, cm	Waist circumference will be checked at week 4, 12, and 24.	24 weeks	No
Secondary	triglyceride, mg/dL	Triglyceride will be checked at week 4, 12, and 24.	24 weeks	No
Secondary	high density lipoprotein cholesterol (HDL-C), mg/dL	HDL-C will be checked at week 4, 12, and 24.	24 weeks	No
Secondary	fasting blood sugar level, mg/dL	fasting blood sugar level will be checked at week 4, 12, and 24.	24 weeks	No