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Folate Supplementation in Schizophrenia
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Massachusetts General Hospital
National Alliance for Research on Schizophrenia and Depression
Information provided by: Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00249288
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Drug: Folate
Phase IV

MedlinePlus related topics: Schizophrenia
Drug Information available for: Folic acid
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Folate Supplementation in Schizophrenia

Further study details as provided by Massachusetts General Hospital:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: December 2003
Estimated Study Completion Date: September 2008
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Folate
    Folic acid or placebo taken as 2, 1mg capsule daily for 12 weeks
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
  Eligibility

Ages Eligible for Study:   18 Years to 68 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Schizophrenia, any subtype
  2. Ages 18-68
  3. Male or female
  4. 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
  5. Stable antipsychotic dose for > 6 weeks
  6. Capable of providing informed consent

Exclusion Criteria:

  1. Unstable medical illness
  2. Substance abuse
  3. Megaloblastic anemia
  4. Non-english speaking
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00249288

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Alliance for Research on Schizophrenia and Depression
Investigators
Principal Investigator: Donald C. Goff, M.D. Massachusetts General Hospital
  More Information

Responsible Party: Massachusetts General Hospital ( Donald Goff, MD )
Study ID Numbers: 2004P-000495
Study First Received: November 3, 2005
Last Updated: June 25, 2008
ClinicalTrials.gov Identifier: NCT00249288  
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Schizophrenia
Negative Symptoms
Folate

Study placed in the following topic categories:
Folic Acid
Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Vitamin B Complex
Hematinics
Therapeutic Uses
Growth Substances
Vitamins
Hematologic Agents
Physiological Effects of Drugs
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009