Potential Intervention Strategy With Folic Acid and Vitamin B12 in Patients With Schizophrenia
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|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
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.
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Dietary Supplement: folic acid 5 mg/cap Other: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||88 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
- 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.
- 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.
- blood pressure, mmHg [ Time Frame: 24 weeks ]Blood pressure will be checked at week 4, 12, and 24.
- waist circumference, cm [ Time Frame: 24 weeks ]Waist circumference will be checked at week 4, 12, and 24.
- triglyceride, mg/dL [ Time Frame: 24 weeks ]Triglyceride will be checked at week 4, 12, and 24.
- high density lipoprotein cholesterol (HDL-C), mg/dL [ Time Frame: 24 weeks ]HDL-C will be checked at week 4, 12, and 24.
- fasting blood sugar level, mg/dL [ Time Frame: 24 weeks ]fasting blood sugar level will be checked at week 4, 12, and 24.
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
|Contact: Chun-Hsin Chen, MDemail@example.com|
|Taipei Medical University - WanFang Hospital|
|Principal Investigator:||Chun-Hsin Chen, MD||Taipei Medical University|