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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
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* Dietary Supplement: Capsule with folate, Vitamin B12 & pyridoxine
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>vitamin capsule | Dietary Supplement: Capsule with folate, Vitamin B12 & pyridoxine<br> <br> |
| Placebo Comparator: B<br>placebo capsule | Other: placebo<br>* placebo capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood homocysteine levels |  | 12 weeks after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, Schizoaffective Disorder, Homocysteine, Vitamins