An interventional study of Capsule with folate, Vitamin B12 & pyridoxine and placebo in Schizophrenia and Schizoaffective Disorder, sponsored by Nathan Kline Institute for Psychiatric Research. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2007-08-23.
Sponsored by Nathan Kline Institute for Psychiatric Research · Not applicable, Interventional, and Treatment
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.
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.
3,472 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 50 is below the median of 70 across 2,873 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Nathan Kline Institute for Psychiatric Research is the lead sponsor of 22 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
vitamin capsule
Dietary Supplement: Capsule with folate, Vitamin B12 & pyridoxine
placebo capsule
Other: placebo
placebo capsule
blood homocysteine levels
Time frame: 12 weeks after baseline
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
This study is completed, as verified in Aug 2007. You cannot join it, but the record below documents what was studied.
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Nathan Kline Institute for Psychiatric Research