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

September 22, 2016 updated by: Taipei Medical University WanFang Hospital

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

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 Overview

Status

Unknown

Conditions

Study Type

Interventional

Enrollment (Anticipated)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Taipei, Taiwan
        • Taipei Medical University - WanFang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
placebo
Experimental: folic acid 5 mg/cap
folic acid 5 mg/d and vitamin B12 500 ug/d
the intervention includes folic acid 5 mg/d and vitamin B12 500 ug/d
Other Names:
  • vitamine B12 500 ug/cap

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive and Negative Syndrome Scale (PANSS)
Time Frame: 24 weeks
We used PANSS to evaluate patients' psychopathology at baseline, week-2, 4, 8, 12, 16, 20, and 24.
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CogStat neuropsychological test, including speed of processing, attention, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition
Time Frame: 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.
24 weeks
blood pressure, mmHg
Time Frame: 24 weeks
Blood pressure will be checked at week 4, 12, and 24.
24 weeks
waist circumference, cm
Time Frame: 24 weeks
Waist circumference will be checked at week 4, 12, and 24.
24 weeks
triglyceride, mg/dL
Time Frame: 24 weeks
Triglyceride will be checked at week 4, 12, and 24.
24 weeks
high density lipoprotein cholesterol (HDL-C), mg/dL
Time Frame: 24 weeks
HDL-C will be checked at week 4, 12, and 24.
24 weeks
fasting blood sugar level, mg/dL
Time Frame: 24 weeks
fasting blood sugar level will be checked at week 4, 12, and 24.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Chun-Hsin Chen, MD, Taipei Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

August 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

August 29, 2016

First Submitted That Met QC Criteria

September 22, 2016

First Posted (Estimate)

September 27, 2016

Study Record Updates

Last Update Posted (Estimate)

September 27, 2016

Last Update Submitted That Met QC Criteria

September 22, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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