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

Primary Purpose

Schizophrenia

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
folic acid 5 mg/cap
Placebo
Sponsored by
Taipei Medical University WanFang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Taipei Medical University - WanFang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

folic acid 5 mg/cap

placebo

Arm Description

folic acid 5 mg/d and vitamin B12 500 ug/d

placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
blood pressure, mmHg
Blood pressure will be checked at week 4, 12, and 24.
waist circumference, cm
Waist circumference will be checked at week 4, 12, and 24.
triglyceride, mg/dL
Triglyceride will be checked at week 4, 12, and 24.
high density lipoprotein cholesterol (HDL-C), mg/dL
HDL-C will be checked at week 4, 12, and 24.
fasting blood sugar level, mg/dL
fasting blood sugar level will be checked at week 4, 12, and 24.

Full Information

First Posted
August 29, 2016
Last Updated
September 22, 2016
Sponsor
Taipei Medical University WanFang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02916121
Brief Title
Potential Intervention Strategy With Folic Acid and Vitamin B12 in Patients With Schizophrenia
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University WanFang Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators study aims are: To investigate folate, vitamin B12, and homocysteine levels in patients with schizophrenia. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
folic acid 5 mg/cap
Arm Type
Experimental
Arm Description
folic acid 5 mg/d and vitamin B12 500 ug/d
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
folic acid 5 mg/cap
Other Intervention Name(s)
vitamine B12 500 ug/cap
Intervention Description
the intervention includes folic acid 5 mg/d and vitamin B12 500 ug/d
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Positive and Negative Syndrome Scale (PANSS)
Description
We used PANSS to evaluate patients' psychopathology at baseline, week-2, 4, 8, 12, 16, 20, and 24.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
CogStat neuropsychological test, including speed of processing, attention, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition
Description
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
Title
blood pressure, mmHg
Description
Blood pressure will be checked at week 4, 12, and 24.
Time Frame
24 weeks
Title
waist circumference, cm
Description
Waist circumference will be checked at week 4, 12, and 24.
Time Frame
24 weeks
Title
triglyceride, mg/dL
Description
Triglyceride will be checked at week 4, 12, and 24.
Time Frame
24 weeks
Title
high density lipoprotein cholesterol (HDL-C), mg/dL
Description
HDL-C will be checked at week 4, 12, and 24.
Time Frame
24 weeks
Title
fasting blood sugar level, mg/dL
Description
fasting blood sugar level will be checked at week 4, 12, and 24.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 20-65 year-old. Fulfill DSM-IV-TR diagnosis of schizophrenia. Be treated with an antipsychotic agent for at least 6 months or at a stable dose for at least 3 months. 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: Medically unstable. Currently taking vitamin supplementation. Pregnancy or lactation. Test positive of urine drug screen Megaloblastic anemia due to folate deficiency; Patients with parkinsonism (score of > 12 on the Simpson-Angus Scale); History of alcohol or other substances use disorder in past 3 months; History of significant neurological illness; Creatine>1.4 ng/dl.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chun-Hsin Chen, MD
Phone
886-970-746395
Email
chunhsin57@yahoo.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chun-Hsin Chen, MD
Organizational Affiliation
Taipei Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Medical University - WanFang Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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