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

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Dietary Supplement: Capsule with folate, Vitamin B12 & pyridoxine
• Other: placebo
  • placebo capsule

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • vitamin capsule
• Placebo Comparator: B
  • placebo capsule

Primary Measures

• blood homocysteine levels
  • Time Frame: 12 weeks after baseline
    

Secondary Measures

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

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Nathan Kline Institute for Psychiatric Research

Overall Clinical Trial Officials and Contacts

William M Greenberg, M.D. Principal Investigator The Nathan Kline Institute for Psychiatric Research  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00403247

Study ID Number: 04T-536

ClinicalTrials.gov Identifier: NCT00403247

Health Authority: United States: Institutional Review Board