NCT01091506

A Placebo-Controlled Study of Physiologic Effects of L-methylfolate in Schizophrenia Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Pamlab, Inc. · Industry
• Sex: All
• Age: 18 Years – 68 Years
• Healthy volunteers: Not accepted

Summary

This study is a 12-week, double-blind, placebo-controlled trial of L-methylfolate 15 mg/d supplementation in schizophrenia patients with mild or greater negative symptoms. L-methylfolate, a prescription medical food, is the activated form of folate required for conversion of homocysteine to methionine and hence is the optimal form of folate for supplementation, since it eliminates the need for activation by MTHFR. The purpose of this study is to examine the change in plasma L-methylfolate concentrations following a three-month trial of L-methylfolate 15 mg/d compared to placebo.

Detailed description

Blood levels of L-methylfolate and biological activity will be evaluated by examining changes in plasma homocysteine concentrations, serum methionine concentrations and changes in brain activation as measured by fMRI.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
OTHER	Placebo	Placebo once a day for 12 weeks
OTHER	L-methylfolate	L-methylfolate 15mg once a day for 12 weeks

Timeline

• Start date: 2010-03-01
• Primary completion: 2014-03-01
• Completion: 2014-06-01
• First posted: 2010-03-24
• Last updated: 2016-08-03

Locations

1 site across 1 country: United States