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

2014-08-27 03:15:04 | BioPortfolio

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.

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.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Conditions

Schizophrenia

Intervention

Placebo, L-methylfolate

Location

Massachusetts General Hospital (MGH) Schizophrenia Program at Freedom Trail Clinic
Boston
Massachusetts
United States

Status

Recruiting

Source

Pamlab, L.L.C.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:04-0400

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