Status:
COMPLETED
Effect of High-Dose B-Complex Vitamins on the Symptoms of Schizophrenia
Lead Sponsor:
Nathan Kline Institute for Psychiatric Research
Collaborating Sponsors:
Stanley Medical Research Institute
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
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-glutama...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00403247
Start Date
July 1 2004
End Date
July 1 2007
Last Update
August 23 2007
Active Locations (1)
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1
The Nathan Kline Institute for Psychiatric Research
Orangeburg, New York, United States, 10962