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Sponsors and Collaborators: |
Nathan Kline Institute for Psychiatric Research Stanley Medical Research Institute |
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Information provided by: | Nathan Kline Institute for Psychiatric Research |
ClinicalTrials.gov Identifier: | NCT00403247 |
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.
Condition | Intervention |
---|---|
Schizophrenia Schizoaffective Disorder |
Dietary Supplement: Capsule with folate, Vitamin B12 & pyridoxine Other: placebo |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Double-Blind Vitamin Intervention to Lower Blood Homocysteine Levels: Amino Acid and Clinical Responses in Individuals With Schizophrenia. |
Enrollment: | 50 |
Study Start Date: | July 2004 |
Study Completion Date: | July 2007 |
Arms | Assigned Interventions |
---|---|
A: Experimental
vitamin capsule
|
Dietary Supplement: Capsule with folate, Vitamin B12 & pyridoxine |
B: Placebo Comparator
placebo capsule
|
Other: placebo
placebo capsule
|
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
The Nathan Kline Institute for Psychiatric Research | |
Orangeburg, New York, United States, 10962 |
Principal Investigator: | William M Greenberg, M.D. | The Nathan Kline Institute for Psychiatric Research |
Study ID Numbers: | 04T-536 |
Study First Received: | November 22, 2006 |
Last Updated: | August 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00403247 |
Health Authority: | United States: Institutional Review Board |
Schizophrenia Schizoaffective Disorder Homocysteine Vitamins |
Folic Acid Schizophrenia Mental Disorders Hydroxocobalamin Vitamin B 12 |
Pyridoxine Psychotic Disorders Vitamin B 6 Schizophrenia and Disorders with Psychotic Features |
Vitamin B Complex Growth Substances Vitamins |
Physiological Effects of Drugs Micronutrients Pharmacologic Actions |