Clinical trial NCT00249288: Folate Supplementation in Schizophrenia
Official title: Folate Supplementation in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Schizophrenia
Negative Symptoms
Folate
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Alliance for Research on Schizophrenia and Depression
First posted: 2005-11-07
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

1. Schizophrenia, any subtype
2. Ages 18-68
3. Male or female
4. 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
5. Stable antipsychotic dose for \> 6 weeks
6. Capable of providing informed consent

Exclusion Criteria:

1. Unstable medical illness
2. Substance abuse
3. Megaloblastic anemia
4. Non-english speaking

Primary outcomes:
measure: Correlation Between Baseline Blood Folate and Smoking Status
timeFrame: Baseline
measure: Correlation Between Baseline Blood Folate and MTHFR Genotype
timeFrame: Baseline
measure: Correlation Between Baseline Blood Folate Levels and Dietary Intake
timeFrame: Baseline
measure: Efficacy of Folate Supplementation for Reducing Negative Symptoms as Measured by the SANS Modified Total
timeFrame: Baseline score vs. week 12 score
measure: Correlation Between Baseline Serum B12 Levels and Smoking Status
timeFrame: Baseline
measure: Correlation Between Baseline Homocysteine Levels and Smoking Status
timeFrame: Baseline
measure: Correlation Between Baseline Blood B12 Levels and MTHFR Genotype
timeFrame: Baseline
measure: Correlation Between Baseline Blood Homocysteine Levels and MTHFR Genotype
timeFrame: Baseline
measure: Correlation Between Baseline Serum B12 Levels and Dietary Intake
timeFrame: Baseline
measure: Correlation Between Baseline Blood Homocysteine Levels and Dietary Intake
timeFrame: Baseline
measure: Correlation Between Baseline Blood Folate or B12 Levels and Dietary Intake
timeFrame: Baseline
Secondary outcomes:
measure: Correlations Between Baseline Blood Folate and Clinical Ratings of Negative Symptoms by Comparing Lab Levels in Deficit Syndrome Versus Non-deficit Syndrome Patients
timeFrame: Baseline
measure: Correlations Between Baseline Blood B12 Levels and Clinical Ratings of Negative Symptoms by Comparing Lab Levels in Deficit Syndrome Versus Non-deficit Syndrome Patients
timeFrame: Baseline
measure: Correlations Between Baseline Blood Homocysteine Levels and Clinical Ratings of Negative Symptoms by Comparing Lab Levels in Deficit Syndrome Versus Non-deficit Syndrome Patients
timeFrame: Baseline
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Donald C. Goff, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.