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

NCT01091506 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2016-08-03

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Placebo

Placebo once a day for 12 weeks

OTHER

L-methylfolate

L-methylfolate 15mg once a day for 12 weeks

Sponsors & Collaborators

  • Massachusetts General Hospital

    collaborator OTHER

  • Pamlab, Inc.

    lead INDUSTRY

Principal Investigators

  • Joshua Roffman, MD · Massachusetts General Hospital Schizophrenia Program at Freedom Trail Clinic

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
68 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2014-03-31
Completion
2014-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01091506 on ClinicalTrials.gov