Folate Supplementation in Schizophrenia
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Folate Supplementation in Schizophrenia|
- Correlation Between Baseline Blood Folate, Homocysteine or B12 Levels and Dietary Intake or Cigarette Smoking [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Efficacy of Folate Supplementation for Reducing Negative Symptoms as Measured by the SANS [ Time Frame: Baseline score vs. week 12 score ] [ Designated as safety issue: No ]The change from baseline to week 12 on the scale for the assessment of negative symptoms (SANS) total score. Total SANS scores range from 0-100. The SANS is comprised of 5 sub-scales: Affective Flattening or Blunting (score range 0-35), Alogia (score range 0-20), Avolition-Apathy (score range 0-15), Anhedonia-Asociality (score range 0-20), and Attention (0-10). For each sub-scale, the higher the score the more prominent the negative symptoms were. The total score was computed by adding all the sub-scale total scores. To compute change in scores, baseline scores were subtracted from week 12 scores, resulting in a change score. Lower values signify greater improvement (i.e. week 12 score was lower than baseline score).
- Correlations Between Red Blood Cell Folate Concentrations and Clinical Ratings of Negative Symptoms and by Comparing Folate Concentrations in Deficit Syndrome Versus Non-deficit Syndrome Patients [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||December 2003|
|Study Completion Date:||June 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
Participants will receive a 2 mg/ day dose of folate, for 12 weeks
Folic acid taken as 2, 1mg capsule daily for 12 weeks
Other Name: Folate or folic acid
Placebo Comparator: Placebo
Participants will receive a 2 mg/ day dose of placebo, for 12 weeks
Placebo taken as 2, 1mg capsule daily for 12 weeks
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:
- To examine factors potentially contributing to differences in blood folate, homocysteine or B12 levels between patients at baseline, including dietary intake and cigarette smoking.
- To test the hypothesis that low folate is associated with negative symptoms by examining correlations between red blood cell folate concentrations and clinical ratings of negative symptoms and by comparing folate concentrations in deficit syndrome versus non-deficit syndrome patients. We will also control for dietary intake cigarettes smoking, gender, and age.
- To examine the efficacy of folate supplementation for reducing negative symptoms
Please refer to this study by its ClinicalTrials.gov identifier: NCT00249288
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Donald C. Goff, M.D.||Massachusetts General Hospital|