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

Pamlab

Status: Completed

Conditions: Schizophrenia

Treatments: Other: Placebo; Other: L-methylfolate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01091506

D-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 18 to 68 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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55 participants in 2 patient groups, including a placebo group

L-methylfolate

Experimental group

Description:

L-methylfolate 15mg (a medical food)

Treatment:

Other: L-methylfolate

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo