A Placebo-Controlled Study of Physiologic Effects of L-methylfolate in Schizophrenia Patients
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| ClinicalTrials.gov Identifier: NCT01091506 |
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Recruitment Status :
Completed
First Posted : March 24, 2010
Last Update Posted : August 3, 2016
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Sponsor:
Pamlab, Inc.
Collaborator:
Massachusetts General Hospital
Information provided by (Responsible Party):
Pamlab, Inc.
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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 |
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 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
Genetics Home Reference related topics:
Schizophrenia
MedlinePlus related topics:
Schizophrenia
| Arm | Intervention/treatment |
|---|---|
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Experimental: L-methylfolate
L-methylfolate 15mg (a medical food)
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Other: L-methylfolate
L-methylfolate 15mg once a day for 12 weeks
Other Name: Deplin |
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Placebo Comparator: Placebo
Placebo
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Other: Placebo
Placebo once a day for 12 weeks |
Primary Outcome Measures :
- 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 :
- 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 ]
- 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 ]
- Examine the change in negative symptoms (SANS total score) after three months compared to placebo [ Time Frame: Weeks 2, 8, and 12 ]
- 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 ]
- Examine the change in MATRICS cognitive battery composite score after three months compared to placebo [ Time Frame: Weeks 2, 8, and 12 ]
- 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 ]
- 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 ]
- Examine the change in psychotic symptoms (PANSS score) in relation to change in plasma L-methylfolate concentration. [ Time Frame: Weeks 2, 8, and 12 ]
- 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 ]
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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
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
| 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
| Principal Investigator: | Joshua Roffman, MD | Massachusetts General Hospital Schizophrenia Program at Freedom Trail Clinic |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Pamlab, Inc. |
| ClinicalTrials.gov Identifier: | NCT01091506 History of Changes |
| 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.:
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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 Tetrahydrofolates Vitamin B Complex |
Vitamins Micronutrients Growth Substances Physiological Effects of Drugs |