- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00249288
Folate Supplementation in Schizophrenia
March 9, 2018 updated by: Donald C. Goff, MD, Massachusetts General Hospital
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 Overview
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
Study Type
Interventional
Enrollment (Actual)
46
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Folate
Participants will receive a 2 mg/ day dose of folate, for 12 weeks
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Folic acid taken as 2, 1mg capsule daily for 12 weeks
Other Names:
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Placebo Comparator: Placebo
Participants will receive a 2 mg/ day dose of placebo, for 12 weeks
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Placebo taken as 2, 1mg capsule daily for 12 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation Between Baseline Blood Folate and Smoking Status
Time Frame: Baseline
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Baseline blood folate lab levels are reported by smoking status.
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Baseline
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Correlation Between Baseline Blood Folate and MTHFR Genotype
Time Frame: Baseline
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Baseline blood folate lab levels are reported by MTHFR genotype.
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Baseline
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Correlation Between Baseline Blood Folate Levels and Dietary Intake
Time Frame: Baseline
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Baseline blood folate lab levels and dietary intake levels are reported.
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Baseline
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Efficacy of Folate Supplementation for Reducing Negative Symptoms as Measured by the SANS Modified Total
Time Frame: Baseline score vs. week 12 score
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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.
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Baseline score vs. week 12 score
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Correlation Between Baseline Serum B12 Levels and Smoking Status
Time Frame: Baseline
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Baseline serum B12 lab levels are reported by smoking status.
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Baseline
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Correlation Between Baseline Homocysteine Levels and Smoking Status
Time Frame: Baseline
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Baseline blood homocysteine lab levels are reported by smoking status.
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Baseline
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Correlation Between Baseline Blood B12 Levels and MTHFR Genotype
Time Frame: Baseline
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Baseline blood B12 lab levels are reported by MTHFR genotype.
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Baseline
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Correlation Between Baseline Blood Homocysteine Levels and MTHFR Genotype
Time Frame: Baseline
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Baseline blood homocysteine lab levels are reported by MTHFR genotype.
|
Baseline
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Correlation Between Baseline Serum B12 Levels and Dietary Intake
Time Frame: Baseline
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Baseline serum B12 lab levels and dietary intake levels are reported.
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Baseline
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Correlation Between Baseline Blood Homocysteine Levels and Dietary Intake
Time Frame: Baseline
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Baseline blood homocysteine lab levels and dietary intake levels are reported.
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Baseline
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Correlation Between Baseline Blood Folate or B12 Levels and Dietary Intake
Time Frame: Baseline
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Baseline blood folate and B12 lab levels and dietary intake levels are reported.
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlations Between Baseline Blood Folate and Clinical Ratings of Negative Symptoms by Comparing Lab Levels in Deficit Syndrome Versus Non-deficit Syndrome Patients
Time Frame: Baseline
|
Baseline blood folate lab levels are reported by deficit syndrome status.
|
Baseline
|
Correlations Between Baseline Blood B12 Levels and Clinical Ratings of Negative Symptoms by Comparing Lab Levels in Deficit Syndrome Versus Non-deficit Syndrome Patients
Time Frame: Baseline
|
Baseline blood B12 lab levels are reported by deficit syndrome status.
|
Baseline
|
Correlations Between Baseline Blood Homocysteine Levels and Clinical Ratings of Negative Symptoms by Comparing Lab Levels in Deficit Syndrome Versus Non-deficit Syndrome Patients
Time Frame: Baseline
|
Baseline blood homocysteine lab levels are reported by deficit syndrome status.
|
Baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Donald C. Goff, M.D., Massachusetts General Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2003
Primary Completion (Actual)
June 1, 2008
Study Completion (Actual)
June 1, 2008
Study Registration Dates
First Submitted
November 3, 2005
First Submitted That Met QC Criteria
November 3, 2005
First Posted (Estimate)
November 7, 2005
Study Record Updates
Last Update Posted (Actual)
April 5, 2018
Last Update Submitted That Met QC Criteria
March 9, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2004P-000495
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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