Phase 4 N=38 Randomized Quadruple-blind Treatment

Folate Supplementation in Schizophrenia

Schizophrenia

Bottom Line

View on ClinicalTrials.gov: NCT00249288 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2014

Primary outcome: Primary: Correlation Between Baseline Blood Folate and Smoking Status — 14.6; 14.6; 14.2; 614 nanograms per milliliter

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Folate (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Massachusetts General Hospital
Primary completion: Jun 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Correlation Between Baseline Blood Folate and Smoking Status	14.6; 14.6; 14.2; 614; 542; 475	—
PRIMARY Correlation Between Baseline Blood Folate and MTHFR Genotype	13.3; 15.2; 624.8; 542.8	—
PRIMARY Correlation Between Baseline Blood Folate Levels and Dietary Intake	14.5; 569.3	—
PRIMARY Efficacy of Folate Supplementation for Reducing Negative Symptoms as Measured by the SANS Modified Total	-8.5; -9.7	—
PRIMARY Correlation Between Baseline Serum B12 Levels and Smoking Status	625; 436; 574	—
PRIMARY Correlation Between Baseline Homocysteine Levels and Smoking Status	9.1; 10.8; 9	—
PRIMARY Correlation Between Baseline Blood B12 Levels and MTHFR Genotype	605.5; 557.1	—
PRIMARY Correlation Between Baseline Blood Homocysteine Levels and MTHFR Genotype	9.4; 9.6	—
PRIMARY Correlation Between Baseline Serum B12 Levels and Dietary Intake	566.6	—
PRIMARY Correlation Between Baseline Blood Homocysteine Levels and Dietary Intake	9.6	—
PRIMARY Correlation Between Baseline Blood Folate or B12 Levels and Dietary Intake	531.3; 765.7; 198.8; 333.4; 7.5	—
SECONDARY Correlations Between Baseline Blood Folate and Clinical Ratings of Negative Symptoms by Comparing Lab Levels in Deficit Syndrome Versus Non-deficit Syndrome Patients	14.9; 14.0; 585; 546	—
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	603; 513	—
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	9.4; 9.7	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00249288). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.