Potential Intervention Strategy With Folic Acid and Vitamin B12 in Patients With Schizophrenia
NCT ID: NCT02916121
Last Updated: 2016-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
88 participants
INTERVENTIONAL
2016-10-31
2018-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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folic acid 5 mg/cap
folic acid 5 mg/d and vitamin B12 500 ug/d
folic acid 5 mg/cap
the intervention includes folic acid 5 mg/d and vitamin B12 500 ug/d
placebo
placebo
Placebo
placebo
Interventions
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folic acid 5 mg/cap
the intervention includes folic acid 5 mg/d and vitamin B12 500 ug/d
Placebo
placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
20 Years
65 Years
ALL
No
Sponsors
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Taipei Medical University WanFang Hospital
OTHER
Responsible Party
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Principal Investigators
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Chun-Hsin Chen, MD
Role: PRINCIPAL_INVESTIGATOR
Taipei Medical University
Locations
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Taipei Medical University - WanFang Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Other Identifiers
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201408009
Identifier Type: -
Identifier Source: org_study_id
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