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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2014-06-30

Brief Summary

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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.

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Detailed Description

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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

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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L-methylfolate

L-methylfolate 15mg (a medical food)

Group Type EXPERIMENTAL

L-methylfolate

Intervention Type OTHER

L-methylfolate 15mg once a day for 12 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo once a day for 12 weeks

Interventions

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Placebo

Placebo once a day for 12 weeks

Intervention Type OTHER

L-methylfolate

L-methylfolate 15mg once a day for 12 weeks

Intervention Type OTHER

Other Intervention Names

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Deplin

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of schizophrenia, any subtype
* Male of female
* Age 18-68 years
* Treated with an antipsychotic for at least 6 months at a stable dose for at least 6 weeks
* PANSS total score of at least 60, with at least 3 (moderate) on one negative symptom item or on one positive symptom item
* Simpson Angus Scale (SAS) for the EPS total score of 12 or less and
* A score of 2 (mild) or less on all items of the Calgary Depression Rating Scale (CDRS)
* Comprehension of English adequate to complete cognitive testing

Exclusion Criteria

* Unable to provide informed consent
* CBC results consistent with megaloblastic anemia
* Serum creatinine concentration greater than 1.4
* Current use of folate supplementation \> 400mcg folate
* Alcohol or other substance abuse within 3 months (nicotine allowed)
* Current use of any of the following medications: phenobarbital, phenytoin, carbamazepine, valproic acid, fosphenytoin, primidone or pyrimethamine
* Positive baseline urine toxic screen, (positive test for PCP, barbiturates, cannabinoids, amphetamines, benzodiazepines, opiates, or cocaine)
* Unstable medical illness (exclusionary lab values are listed in Appendix A)
* Unstable psychiatric illness
* Seizure disorder
* Pregnant or nursing, or planning/trying to get pregnant within the next 6 months, and
* DSM-IV diagnosis of major depressive disorder

Minimum Eligible Age

18 Years

Maximum Eligible Age

68 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No