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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02916121
Recruitment Status : Unknown
Verified August 2016 by Taipei Medical University WanFang Hospital.
Recruitment status was:  Not yet recruiting
First Posted : September 27, 2016
Last Update Posted : September 27, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Dietary Supplement: folic acid 5 mg/cap Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : October 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Experimental: folic acid 5 mg/cap
folic acid 5 mg/d and vitamin B12 500 ug/d
Dietary Supplement: folic acid 5 mg/cap
the intervention includes folic acid 5 mg/d and vitamin B12 500 ug/d
Other Name: vitamine B12 500 ug/cap

Placebo Comparator: placebo
placebo
Other: Placebo
placebo




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. blood pressure, mmHg [ Time Frame: 24 weeks ]
    Blood pressure will be checked at week 4, 12, and 24.

  3. waist circumference, cm [ Time Frame: 24 weeks ]
    Waist circumference will be checked at week 4, 12, and 24.

  4. triglyceride, mg/dL [ Time Frame: 24 weeks ]
    Triglyceride will be checked at week 4, 12, and 24.

  5. high density lipoprotein cholesterol (HDL-C), mg/dL [ Time Frame: 24 weeks ]
    HDL-C will be checked at week 4, 12, and 24.

  6. fasting blood sugar level, mg/dL [ Time Frame: 24 weeks ]
    fasting blood sugar level will be checked at week 4, 12, and 24.



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02916121


Contacts
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Contact: Chun-Hsin Chen, MD 886-970-746395 chunhsin57@yahoo.com.tw

Locations
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Taiwan
Taipei Medical University - WanFang Hospital
Taipei, Taiwan
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Investigators
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Principal Investigator: Chun-Hsin Chen, MD Taipei Medical University
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Responsible Party: Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier: NCT02916121    
Other Study ID Numbers: 201408009
First Posted: September 27, 2016    Key Record Dates
Last Update Posted: September 27, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Folic Acid
Vitamin B 12
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hematinics
Vitamin B Complex