Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00249288
Status:
COMPLETED
Last Update Posted:
2018-04-05
First Post:
2005-11-03
Brief Title:
Folate Supplementation in Schizophrenia
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Folate Supplementation in Schizophrenia
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to examine factors potentially contributing to differences in blood folate homocysteine or B12 levels between schizophrenia patients to test the hypothesis that low folate is associated with negative symptoms and to examine the efficacy of folate supplementation for reducing negative symptoms
Detailed Description:
This study is a three-month placebo-controlled trial of folate 2mgd in 50 schizophrenia patients who score at least a 3 moderate or greater severity on at least one of the SANS global assessment subscales with the exception of the attention global assessment subscale The specific aims of this study are
To examine factors potentially contributing to differences in blood folate homocysteine or B12 levels between patients at baseline including dietary intake and cigarette smoking
To test the hypothesis that low folate is associated with negative symptoms by examining correlations between red blood cell folate concentrations and clinical ratings of negative symptoms and by comparing folate concentrations in deficit syndrome versus non-deficit syndrome patients We will also control for dietary intake cigarettes smoking gender and age
To examine the efficacy of folate supplementation for reducing negative symptoms
To examine factors potentially contributing to differences in blood folate homocysteine or B12 levels between patients at baseline including dietary intake and cigarette smoking
To test the hypothesis that low folate is associated with negative symptoms by examining correlations between red blood cell folate concentrations and clinical ratings of negative symptoms and by comparing folate concentrations in deficit syndrome versus non-deficit syndrome patients We will also control for dietary intake cigarettes smoking gender and age
To examine the efficacy of folate supplementation for reducing negative symptoms
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None