Folate Supplementation in Schizophrenia

This study has been completed.

Sponsor:

Collaborator:

National Alliance for Research on Schizophrenia and Depression

Information provided by:

Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT00249288

First received: November 3, 2005

Last updated: June 27, 2011

Last verified: June 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

November 3, 2005

Last Updated Date

June 27, 2011

Start Date ^ICMJE

December 2003

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Correlation between baseline blood folate, homocysteine or B12 levels and dietary intake or cigarette smoking [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00249288 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Correlations between red blood cell folate concentrations and clinical ratings of negative symptoms and by comparing folate concentrations in deficit syndrome versus non-deficit syndrome patients [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Efficacy of folate supplementation for reducing negative symptoms as measured by the SANS [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Folate Supplementation in Schizophrenia

Official Title ^ICMJE

Folate Supplementation in Schizophrenia

Brief Summary

This study aims to examine factors potentially contributing to differences in blood folate, homocysteine or B12 levels between schizophrenia patients, to test the hypothesis that low folate is associated with negative symptoms, and to examine the efficacy of folate supplementation for reducing negative symptoms.

Detailed Description

This study is a three-month, placebo-controlled trial of folate 2mg/d in 50 schizophrenia patients who score at least a 3 (moderate or greater severity) on at least one of the SANS global assessment subscales, with the exception of the attention global assessment subscale. The specific aims of this study are:

To examine factors potentially contributing to differences in blood folate, homocysteine or B12 levels between patients at baseline, including dietary intake and cigarette smoking.
To test the hypothesis that low folate is associated with negative symptoms by examining correlations between red blood cell folate concentrations and clinical ratings of negative symptoms and by comparing folate concentrations in deficit syndrome versus non-deficit syndrome patients. We will also control for dietary intake cigarettes smoking, gender, and age.
To examine the efficacy of folate supplementation for reducing negative symptoms

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Schizophrenia

Intervention ^ICMJE

Drug: Folate

Folic acid or placebo taken as 2, 1mg capsule daily for 12 weeks

Other Name: Folate or folic acid

Study Arm (s)

Not Provided

Publications *

Hill M, Shannahan K, Jasinski S, Macklin EA, Raeke L, Roffman JL, Goff DC. Folate supplementation in schizophrenia: a possible role for MTHFR genotype. Schizophr Res. 2011 Apr;127(1-3):41-5. Epub 2011 Feb 21.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2008

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Schizophrenia, any subtype
Ages 18-68
Male or female
A score at least a 3 (moderate or greater severity) on at least one of the SANS global assessment subscales, with the exception of the attention global assessment subscale
Stable antipsychotic dose for > 6 weeks
Capable of providing informed consent

Exclusion Criteria:

Unstable medical illness
Substance abuse
Megaloblastic anemia
Non-english speaking

Gender

Both

Ages

18 Years to 68 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00249288

Other Study ID Numbers ^ICMJE

2004P-000495

Has Data Monitoring Committee

Responsible Party

Donald Goff, MD, Massachusetts General Hospital

Study Sponsor ^ICMJE

Massachusetts General Hospital

Collaborators ^ICMJE

National Alliance for Research on Schizophrenia and Depression

Investigators ^ICMJE

Principal Investigator:

Donald C. Goff, M.D.

Massachusetts General Hospital

Information Provided By

Massachusetts General Hospital

Verification Date

June 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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