NCT00403247

Effect of High-Dose B-Complex Vitamins on the Symptoms of Schizophrenia

Double-Blind Vitamin Intervention to Lower Blood Homocysteine Levels: Amino Acid and Clinical Responses in Individuals With Schizophrenia.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Nathan Kline Institute for Psychiatric Research · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 (e.g., PANSS, CGI) will be taken to determine whether those taking the vitamin combination experience clinical benefit.

Conditions

• Schizophrenia
• Schizoaffective Disorder

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Capsule with folate, Vitamin B12 & pyridoxine
OTHER	placebo	placebo capsule

Timeline

• Start date: 2004-07-01
• Completion: 2007-07-01
• First posted: 2006-11-23
• Last updated: 2007-08-23

Locations

1 site across 1 country: United States