A Placebo-Controlled Study of Physiologic Effects of L-me... | NCT01091506

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

NCT01091506

Sponsor

Pamlab, Inc.

Status

Completed

Last Update Posted

Aug 3, 2016Estimated

Enrollment

55Actual

Phase

Not Applicable

Conditions

Schizophrenia

Interventions

Placebo
L-methylfolate

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Mar 2014Actual

Completion Date

Jun 2014Actual

First Submitted Date

Mar 22, 2010

First Submission Date that Met QC Criteria

Mar 23, 2010

First Posted Date

Mar 24, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 2, 2016

Last Update Posted Date

Aug 3, 2016Estimated

Name	Class
Massachusetts General Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

55Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
L-methylfolate	Experimental	L-methylfolate 15mg (a medical food)	Other: L-methylfolate
Placebo	Placebo Comparator	Placebo	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Other	Placebo once a day for 12 weeks	Placebo
L-methylfolate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Examine the change in plasma L-methylfolate concentrations following a three-month trial of L-methylfolate 15 mg/d compared to placebo.		Weeks 2, 8, and 12

Secondary Outcomes

Measure	Description	Time Frame
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.		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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

68 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joshua Roffman, MD	Massachusetts General Hospital Schizophrenia Program at Freedom Trail Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital (MGH) Schizophrenia Program at Freedom Trail Clinic		Boston	Massachusetts		United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28289280	Derived	Roffman JL, Petruzzi LJ, Tanner AS, Brown HE, Eryilmaz H, Ho NF, Giegold M, Silverstein NJ, Bottiglieri T, Manoach DS, Smoller JW, Henderson DC, Goff DC. Biochemical, physiological and clinical effects of l-methylfolate in schizophrenia: a randomized controlled trial. Mol Psychiatry. 2018 Feb;23(2):316-322. doi: 10.1038/mp.2017.41. Epub 2017 Mar 14.

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders