- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02916121
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:
- 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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
- Name: Chun-Hsin Chen, MD
- Phone Number: 886-970-746395
- Email: chunhsin57@yahoo.com.tw
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:
- 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.
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:
|
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201408009
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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