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

Not Applicable

Completed

• Conditions: Schizophrenia; Schizoaffective Disorder
• Interventions: Dietary Supplement: Capsule with folate, Vitamin B12 & pyridoxine; Other: placebo

• Registration Number: NCT00403247
• Lead Sponsor: Nathan Kline Institute for Psychiatric Research

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

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2006-11-22
• Study First Submitted QC: 2006-11-22
• Study First Posted: 2006-11-23
• Study Completion: 2007-07
• Status Verified: 2007-08
• Last Update Submitted: 2007-08-21
• Last Update Posted: 2007-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Clinical diagnosis of Schizophrenia or Schizoaffective Disorder
• Ages 18-65, male or female
• Treatment regimen includes a new-generation antipsychotic (clozapine, olanzapine,risperidone, quetiapine, ziprasidone or aripiprazole)
• Stable medication for 4 weeks prior to screening visit

Exclusion Criteria

• Diagnosis of active substance use disorder within the last month
• Already taking vitamin supplements totaling > 400 mcg folic acid per day, or regular B12 injections
• Pregnant or breastfeeding
• Seizure disorder
• Non-English speaking
• Without capacity to give informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Capsule with folate, Vitamin B12 & pyridoxine	vitamin capsule
B	placebo	placebo capsule

Primary Outcome Measures

Name	Time	Method
blood homocysteine levels	12 weeks after baseline

Secondary Outcome Measures

Name	Time	Method
CGI (Clinical Global Improvement)	12 weeks after baseline
CDSS (Calgary Depression Scale for Schizophrenia)	12 weeks after baseline
WAIS-II Memory Scale (Immediate and Delayed)	12 weeks after baseline
WAIS Digit Symbol-Coding	12 weeks after baseline
Wisconsin Card Sorting Test	12 weeks after baseline
WAIS-II Letter-Number Sequencing Subtest	12 weeks after baseline

Trial Locations

Locations (1)

The Nathan Kline Institute for Psychiatric Research; 🇺🇸 Orangeburg, New York, United States