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| Name | Class |
|---|---|
| National Alliance for Research on Schizophrenia and Depression | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Folate | Experimental | Participants will receive a 2 mg/ day dose of folate, for 12 weeks |
|
| Placebo | Placebo Comparator | Participants will receive a 2 mg/ day dose of placebo, for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Folate | Drug | Folic acid taken as 2, 1mg capsule daily for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation Between Baseline Blood Folate and Smoking Status | Baseline blood folate lab levels are reported by smoking status. | Baseline |
| Correlation Between Baseline Blood Folate and MTHFR Genotype | Baseline blood folate lab levels are reported by MTHFR genotype. | Baseline |
| Correlation Between Baseline Blood Folate Levels and Dietary Intake | Baseline blood folate lab levels and dietary intake levels are reported. | Baseline |
| 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. | Baseline score vs. week 12 score |
| Correlation Between Baseline Serum B12 Levels and Smoking Status | Baseline serum B12 lab levels are reported by smoking status. | Baseline |
| Correlation Between Baseline Homocysteine Levels and Smoking Status |
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donald C. Goff, M.D. | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21334854 | Result | 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. |
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Forty six participants were enrolled; 38 completed screening and 32 received study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | Folate | Participants receiving 2 mg/daily of folate, for 12 weeks |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received 2 mg/daily of placebo, for 12 weeks |
| BG001 | Folate | Patients underwent a 12 week trial of folate 2 mg/d |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Correlation Between Baseline Blood Folate and Smoking Status | Baseline blood folate lab levels are reported by smoking status. | 1 past smoker and 1 never smoker are missing RBC folate values. For the present analysis, as opposed to a comparison of treatment groups, folate levels are compared across smoking status. | Posted | Mean | Standard Deviation | nanograms per milliliter | Baseline |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Folate | Participants receiving 2 mg/daily of folate, for 12 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michelle Hill | Schizophrenia Program, Massachusetts General Hospital | 617-912-7846 | michelehill1@gmail.com |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D005492 | Folic Acid |
| ID | Term |
|---|---|
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Placebo | Drug | Placebo taken as 2, 1mg capsule daily for 12 weeks |
|
Baseline blood homocysteine lab levels are reported by smoking status. |
| Baseline |
| Correlation Between Baseline Blood B12 Levels and MTHFR Genotype | Baseline blood B12 lab levels are reported by MTHFR genotype. | Baseline |
| Correlation Between Baseline Blood Homocysteine Levels and MTHFR Genotype | Baseline blood homocysteine lab levels are reported by MTHFR genotype. | Baseline |
| Correlation Between Baseline Serum B12 Levels and Dietary Intake | Baseline serum B12 lab levels and dietary intake levels are reported. | Baseline |
| Correlation Between Baseline Blood Homocysteine Levels and Dietary Intake | Baseline blood homocysteine lab levels and dietary intake levels are reported. | Baseline |
| Correlation Between Baseline Blood Folate or B12 Levels and Dietary Intake | Baseline blood folate and B12 lab levels and dietary intake levels are reported. | 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 | Baseline blood homocysteine lab levels are reported by deficit syndrome status. | Baseline |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Never Smoker |
Participants with never smoker status |
|
|
| Primary | Correlation Between Baseline Blood Folate and MTHFR Genotype | Baseline blood folate lab levels are reported by MTHFR genotype. | One participant with CC genotype is missing RBC folate value. For the present analysis, as opposed to a comparison of treatment groups, folate levels are compared across MTHFR genotype. | Posted | Mean | Standard Deviation | nanograms/mL | Baseline |
|
|
|
| Primary | Correlation Between Baseline Blood Folate Levels and Dietary Intake | Baseline blood folate lab levels and dietary intake levels are reported. | All study participants at baseline. For the present analysis, as opposed to a comparison of treatment groups, folate levels are described for all participants at baseline. | Posted | Mean | Standard Deviation | nanograms/mL | Baseline |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline score vs. week 12 score |
|
|
|
| Primary | Correlation Between Baseline Serum B12 Levels and Smoking Status | Baseline serum B12 lab levels are reported by smoking status. | For the present analysis, as opposed to a comparison of treatment groups, B12 levels are compared across smoking status. | Posted | Mean | Standard Deviation | picograms per milliliter | Baseline |
|
|
|
| Primary | Correlation Between Baseline Homocysteine Levels and Smoking Status | Baseline blood homocysteine lab levels are reported by smoking status. | 1 participant who have never smoker status is missing plasma homocysteine values. For the present analysis, as opposed to a comparison of treatment groups, homocysteine levels are compared across smoking status. | Posted | Mean | Standard Deviation | micromoles per liter | Baseline |
|
|
|
| Primary | Correlation Between Baseline Blood B12 Levels and MTHFR Genotype | Baseline blood B12 lab levels are reported by MTHFR genotype. | For the present analysis, as opposed to a comparison of treatment groups, B12 levels are compared across MTHFR genotype. | Posted | Mean | Standard Deviation | picograms per milliliter | Baseline |
|
|
|
| Primary | Correlation Between Baseline Blood Homocysteine Levels and MTHFR Genotype | Baseline blood homocysteine lab levels are reported by MTHFR genotype. | For the present analysis, as opposed to a comparison of treatment groups, homocystein levels are compared across MTHFR genotype. | Posted | Mean | Standard Deviation | micromoles/liter | Baseline |
|
|
|
| Primary | Correlation Between Baseline Serum B12 Levels and Dietary Intake | Baseline serum B12 lab levels and dietary intake levels are reported. | For the present analysis, as opposed to a comparison of treatment groups, B12 levels are described for all baseline participants. | Posted | Mean | Standard Deviation | picograms/mL | Baseline |
|
|
|
| Primary | Correlation Between Baseline Blood Homocysteine Levels and Dietary Intake | Baseline blood homocysteine lab levels and dietary intake levels are reported. | All study participants at baseline. For the present analysis, as opposed to a comparison of treatment groups, homocysteine levels are described for all baseline participants. | Posted | Mean | Standard Deviation | micromoles/liter | Baseline |
|
|
|
| Primary | Correlation Between Baseline Blood Folate or B12 Levels and Dietary Intake | Baseline blood folate and B12 lab levels and dietary intake levels are reported. | All participants at baseline. For the present analysis, as opposed to a comparison of treatment groups, folate and B12 levels are described for all baseline participants. | Posted | Mean | Standard Deviation | micrograms | Baseline |
|
|
|
| Secondary | 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. | One deficit syndrome participant and one participant without deficit syndrome are missing RBC folate values. For the present analysis, as opposed to a comparison of treatment groups, folate levels are compared across deficit syndrome status. | Posted | Mean | Standard Deviation | nanograms/mL | Baseline |
|
|
|
| Secondary | 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. | For the present analysis, as opposed to a comparison of treatment groups, B12 levels are compared across deficit syndrome status. | Posted | Mean | Standard Deviation | picograms/mL | Baseline |
|
|
|
| Secondary | 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. | One participant without deficit syndrome is missing homocysteine. For the present analysis, as opposed to a comparison of treatment groups, homocysteine levels are compared across deficit syndrome status. | Posted | Mean | Standard Deviation | micromoles/liter | Baseline |
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|
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Placebo | Participants receiving 2mg/daily of placebo, for 12 weeks | 0 | 19 | 0 | 19 |
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| D006571 | Heterocyclic Compounds |
| RBC folate, ng/ml |
|
|
|
| Title | Measurements |
|---|---|
|
| Synthetic folate, mcg |
|
| Total B12, mcg |
|
| RBC folate, ng/ml |
|
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