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Sponsors and Collaborators: |
Massachusetts General Hospital National Alliance for Research on Schizophrenia and Depression |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00249288 |
This study aims to examine factors potentially contributing to differences in blood folate, homocysteine or B12 levels between schizophrenia patients, to test the hypothesis that low folate is associated with negative symptoms, and to examine the efficacy of folate supplementation for reducing negative symptoms.
Condition | Intervention | Phase |
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Schizophrenia |
Drug: Folate |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Folate Supplementation in Schizophrenia |
Estimated Enrollment: | 50 |
Study Start Date: | December 2003 |
Estimated Study Completion Date: | September 2008 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
This study is a three-month, placebo-controlled trial of folate 2mg/d in 50 schizophrenia patients who score at least a 3 (moderate or greater severity) on at least one of the SANS global assessment subscales, with the exception of the attention global assessment subscale. The specific aims of this study are:
Ages Eligible for Study: | 18 Years to 68 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | Donald C. Goff, M.D. | Massachusetts General Hospital |
Responsible Party: | Massachusetts General Hospital ( Donald Goff, MD ) |
Study ID Numbers: | 2004P-000495 |
Study First Received: | November 3, 2005 |
Last Updated: | June 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00249288 |
Health Authority: | United States: Institutional Review Board |
Schizophrenia Negative Symptoms Folate |
Folic Acid Schizophrenia Mental Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |
Vitamin B Complex Hematinics Therapeutic Uses Growth Substances Vitamins |
Hematologic Agents Physiological Effects of Drugs Micronutrients Pharmacologic Actions |