Folate Supplementation in Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Folate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Negative Symptoms, Folate
Eligibility Criteria
Inclusion Criteria: Schizophrenia, any subtype Ages 18-68 Male or female A 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 Stable antipsychotic dose for > 6 weeks Capable of providing informed consent Exclusion Criteria: Unstable medical illness Substance abuse Megaloblastic anemia Non-english speaking
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Folate
Placebo
Arm Description
Participants will receive a 2 mg/ day dose of folate, for 12 weeks
Participants will receive a 2 mg/ day dose of placebo, for 12 weeks
Outcomes
Primary Outcome Measures
Correlation Between Baseline Blood Folate and Smoking Status
Baseline blood folate lab levels are reported by smoking status.
Correlation Between Baseline Blood Folate and MTHFR Genotype
Baseline blood folate lab levels are reported by MTHFR genotype.
Correlation Between Baseline Blood Folate Levels and Dietary Intake
Baseline blood folate lab levels and dietary intake levels are reported.
Efficacy of Folate Supplementation for Reducing Negative Symptoms as Measured by the SANS Modified Total
The change from baseline to week 12 on the scale for the assessment of negative symptoms (SANS) modified 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). The SANS modified total score is the SANS total score minus the Attention subscale.
Correlation Between Baseline Serum B12 Levels and Smoking Status
Baseline serum B12 lab levels are reported by smoking status.
Correlation Between Baseline Homocysteine Levels and Smoking Status
Baseline blood homocysteine lab levels are reported by smoking status.
Correlation Between Baseline Blood B12 Levels and MTHFR Genotype
Baseline blood B12 lab levels are reported by MTHFR genotype.
Correlation Between Baseline Blood Homocysteine Levels and MTHFR Genotype
Baseline blood homocysteine lab levels are reported by MTHFR genotype.
Correlation Between Baseline Serum B12 Levels and Dietary Intake
Baseline serum B12 lab levels and dietary intake levels are reported.
Correlation Between Baseline Blood Homocysteine Levels and Dietary Intake
Baseline blood homocysteine lab levels and dietary intake levels are reported.
Correlation Between Baseline Blood Folate or B12 Levels and Dietary Intake
Baseline blood folate and B12 lab levels and dietary intake levels are reported.
Secondary Outcome Measures
Correlations Between Baseline Blood Folate and Clinical Ratings of Negative Symptoms by Comparing Lab Levels in Deficit Syndrome Versus Non-deficit Syndrome Patients
Baseline blood folate lab levels are reported by deficit syndrome status.
Correlations Between Baseline Blood B12 Levels and Clinical Ratings of Negative Symptoms by Comparing Lab Levels in Deficit Syndrome Versus Non-deficit Syndrome Patients
Baseline blood B12 lab levels are reported by deficit syndrome status.
Correlations Between Baseline Blood Homocysteine Levels and Clinical Ratings of Negative Symptoms by Comparing Lab Levels in Deficit Syndrome Versus Non-deficit Syndrome Patients
Baseline blood homocysteine lab levels are reported by deficit syndrome status.
Full Information
NCT ID
NCT00249288
First Posted
November 3, 2005
Last Updated
March 9, 2018
Sponsor
Massachusetts General Hospital
Collaborators
National Alliance for Research on Schizophrenia and Depression
1. Study Identification
Unique Protocol Identification Number
NCT00249288
Brief Title
Folate Supplementation in Schizophrenia
Official Title
Folate Supplementation in Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Alliance for Research on Schizophrenia and Depression
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Negative Symptoms, Folate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Folate
Arm Type
Experimental
Arm Description
Participants will receive a 2 mg/ day dose of folate, for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive a 2 mg/ day dose of placebo, for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Folate
Other Intervention Name(s)
Folate or folic acid
Intervention Description
Folic acid taken as 2, 1mg capsule daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo taken as 2, 1mg capsule daily for 12 weeks
Primary Outcome Measure Information:
Title
Correlation Between Baseline Blood Folate and Smoking Status
Description
Baseline blood folate lab levels are reported by smoking status.
Time Frame
Baseline
Title
Correlation Between Baseline Blood Folate and MTHFR Genotype
Description
Baseline blood folate lab levels are reported by MTHFR genotype.
Time Frame
Baseline
Title
Correlation Between Baseline Blood Folate Levels and Dietary Intake
Description
Baseline blood folate lab levels and dietary intake levels are reported.
Time Frame
Baseline
Title
Efficacy of Folate Supplementation for Reducing Negative Symptoms as Measured by the SANS Modified Total
Description
The change from baseline to week 12 on the scale for the assessment of negative symptoms (SANS) modified 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). The SANS modified total score is the SANS total score minus the Attention subscale.
Time Frame
Baseline score vs. week 12 score
Title
Correlation Between Baseline Serum B12 Levels and Smoking Status
Description
Baseline serum B12 lab levels are reported by smoking status.
Time Frame
Baseline
Title
Correlation Between Baseline Homocysteine Levels and Smoking Status
Description
Baseline blood homocysteine lab levels are reported by smoking status.
Time Frame
Baseline
Title
Correlation Between Baseline Blood B12 Levels and MTHFR Genotype
Description
Baseline blood B12 lab levels are reported by MTHFR genotype.
Time Frame
Baseline
Title
Correlation Between Baseline Blood Homocysteine Levels and MTHFR Genotype
Description
Baseline blood homocysteine lab levels are reported by MTHFR genotype.
Time Frame
Baseline
Title
Correlation Between Baseline Serum B12 Levels and Dietary Intake
Description
Baseline serum B12 lab levels and dietary intake levels are reported.
Time Frame
Baseline
Title
Correlation Between Baseline Blood Homocysteine Levels and Dietary Intake
Description
Baseline blood homocysteine lab levels and dietary intake levels are reported.
Time Frame
Baseline
Title
Correlation Between Baseline Blood Folate or B12 Levels and Dietary Intake
Description
Baseline blood folate and B12 lab levels and dietary intake levels are reported.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Correlations Between Baseline Blood Folate and Clinical Ratings of Negative Symptoms by Comparing Lab Levels in Deficit Syndrome Versus Non-deficit Syndrome Patients
Description
Baseline blood folate lab levels are reported by deficit syndrome status.
Time Frame
Baseline
Title
Correlations Between Baseline Blood B12 Levels and Clinical Ratings of Negative Symptoms by Comparing Lab Levels in Deficit Syndrome Versus Non-deficit Syndrome Patients
Description
Baseline blood B12 lab levels are reported by deficit syndrome status.
Time Frame
Baseline
Title
Correlations Between Baseline Blood Homocysteine Levels and Clinical Ratings of Negative Symptoms by Comparing Lab Levels in Deficit Syndrome Versus Non-deficit Syndrome Patients
Description
Baseline blood homocysteine lab levels are reported by deficit syndrome status.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Schizophrenia, any subtype
Ages 18-68
Male or female
A 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
Stable antipsychotic dose for > 6 weeks
Capable of providing informed consent
Exclusion Criteria:
Unstable medical illness
Substance abuse
Megaloblastic anemia
Non-english speaking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald C. Goff, M.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21334854
Citation
Hill M, Shannahan K, Jasinski S, Macklin EA, Raeke L, Roffman JL, Goff DC. Folate supplementation in schizophrenia: a possible role for MTHFR genotype. Schizophr Res. 2011 Apr;127(1-3):41-5. doi: 10.1016/j.schres.2010.12.006. Epub 2011 Feb 21.
Results Reference
result
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Folate Supplementation in Schizophrenia
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