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

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ClinicalTrials.gov Identifier: NCT01091506
Recruitment Status : Completed
First Posted : March 24, 2010
Last Update Posted : August 3, 2016
Sponsor:
Collaborator:
Massachusetts General Hospital
Information provided by (Responsible Party):
Pamlab, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Schizophrenia Other: Placebo Other: L-methylfolate Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Placebo-Controlled Study of Physiologic Effects of L-methylfolate in Schizophrenia Patients
Study Start Date : March 2010
Actual Primary Completion Date : March 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arms and Interventions
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Arm Intervention/treatment
Experimental: L-methylfolate
L-methylfolate 15mg (a medical food)
 Other: L-methylfolate
L-methylfolate 15mg once a day for 12 weeks
Other Name: Deplin
Placebo Comparator: Placebo
Placebo
 Other: Placebo
Placebo once a day for 12 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Examine the change in plasma L-methylfolate concentrations following a three-month trial of L-methylfolate 15 mg/d compared to placebo. [ Time Frame: Weeks 2, 8, and 12 ]

Secondary Outcome Measures :
  1. Examine the change in brain activation in patients receiving L-methylfolate 15 mg/d versus placebo as measured by fMRI using Sternberg's Iterm Recognition Paradigm, as well as changes in cortical thickness and connectivity. [ Time Frame: Week 12 ]
  2. Examine the relationship between MTHFR genotype, change in plasma homocysteine, and methionine concentration, and change in DLPC activation in subjects receiving L-methylfolate [ Time Frame: Weeks 2, 8, and 12 ]
  3. Examine the change in negative symptoms (SANS total score) after three months compared to placebo [ Time Frame: Weeks 2, 8, and 12 ]
  4. Examine the change in negative symptoms (SANS total score) in relation to change in plasma L-methylfolate levels [ Time Frame: Weeks 2, 8, and 12 ]
  5. Examine the change in MATRICS cognitive battery composite score after three months compared to placebo [ Time Frame: Weeks 2, 8, and 12 ]
  6. Examine the change in MATRICS cognitive battery composite score after three months in relation to change in plasma L-methylfolate concentration. [ Time Frame: Weeks 2, 8, and 12 ]
  7. Examine the change in psychotic symptoms as measured by the PANSS total and subscale scores after three months compared to placebo [ Time Frame: Weeks 2, 8, and 12 ]
  8. Examine the change in psychotic symptoms (PANSS score) in relation to change in plasma L-methylfolate concentration. [ Time Frame: Weeks 2, 8, and 12 ]
  9. Examine the change in plasma homocysteine and methionine concentrations following a three-month trial of L-methylfolate 15 mg/d compared to placebo. [ Time Frame: Weeks 2, 8, and 12 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 68 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01091506


Locations
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United States, Massachusetts
Massachusetts General Hospital (MGH) Schizophrenia Program at Freedom Trail Clinic
Boston, Massachusetts, United States
Sponsors and Collaborators
Pamlab, Inc.
Massachusetts General Hospital
Investigators
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Principal Investigator: Joshua Roffman, MD Massachusetts General Hospital Schizophrenia Program at Freedom Trail Clinic
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pamlab, Inc.
ClinicalTrials.gov Identifier: NCT01091506    
Other Study ID Numbers: D-003
First Posted: March 24, 2010    Key Record Dates
Last Update Posted: August 3, 2016
Last Verified: January 2015
Keywords provided by Pamlab, Inc.:
L-methylfolate
Deplin
schizophrenia
folate
folic acid
homocysteine
methionine
 MTHFR genotype
C677T mutation
vitamin B6
vitamin B12
psychotic symptoms
MTHFR C677T Polymorphism
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders