Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00403247
Status:
COMPLETED
Last Update Posted:
2007-08-23
First Post:
2006-11-22
Brief Title:
Effect of High-Dose B-Complex Vitamins on the Symptoms of Schizophrenia
Sponsor:
Nathan Kline Institute for Psychiatric Research
Organization:
Nathan Kline Institute for Psychiatric Research
Study Overview
Official Title:
Double-Blind Vitamin Intervention to Lower Blood Homocysteine Levels Amino Acid and Clinical Responses in Individuals With Schizophrenia
Status:
COMPLETED
Status Verified Date:
2007-08
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:
The purpose of this study is to determine whether individuals with schizophrenia who will take a high dose of the B-vitamins folate B12 and pyridoxine may experience improvement in their symptoms
Detailed Description:
Individuals with schizophrenia often experience disturbing residual symptoms even with the best available current treatments Homocysteine normally found in the body can interfere with NMDA-glutamate receptor function and this might be responsible for some of the symptoms of schizophrenia This double-blind protocol will have study participants who suffer from schizophrenia take either a high-dose combination of folate B12 and pyridoxine a combination that can lower homocysteine in the body or placebo for three months Clinical measures eg PANSS CGI will be taken to determine whether those taking the vitamin combination experience clinical benefit
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