ClinicalTrials.gov
ClinicalTrials.gov Menu

Folate Supplementation in Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00249288
Recruitment Status : Completed
First Posted : November 7, 2005
Results First Posted : August 6, 2014
Last Update Posted : April 5, 2018
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Donald C. Goff, MD, Massachusetts General Hospital

November 3, 2005
November 7, 2005
June 11, 2014
August 6, 2014
April 5, 2018
December 2003
June 2008   (Final data collection date for primary outcome measure)
  • Correlation Between Baseline Blood Folate and Smoking Status [ Time Frame: Baseline ]
    Baseline blood folate lab levels are reported by smoking status.
  • Correlation Between Baseline Blood Folate and MTHFR Genotype [ Time Frame: Baseline ]
    Baseline blood folate lab levels are reported by MTHFR genotype.
  • Correlation Between Baseline Blood Folate Levels and Dietary Intake [ Time Frame: Baseline ]
    Baseline blood folate lab levels and dietary intake levels are reported.
  • Efficacy of Folate Supplementation for Reducing Negative Symptoms as Measured by the SANS Modified Total [ Time Frame: Baseline score vs. week 12 score ]
    The change from baseline to week 12 on the scale for the assessment of negative symptoms (SANS) modified total score. Total SANS scores range from 0-100. The SANS is comprised of 5 sub-scales: Affective Flattening or Blunting (score range 0-35), Alogia (score range 0-20), Avolition-Apathy (score range 0-15), Anhedonia-Asociality (score range 0-20), and Attention (0-10). For each sub-scale, the higher the score the more prominent the negative symptoms were. The total score was computed by adding all the sub-scale total scores. To compute change in scores, baseline scores were subtracted from week 12 scores, resulting in a change score. Lower values signify greater improvement (i.e. week 12 score was lower than baseline score). The SANS modified total score is the SANS total score minus the Attention subscale.
  • Correlation Between Baseline Serum B12 Levels and Smoking Status [ Time Frame: Baseline ]
    Baseline serum B12 lab levels are reported by smoking status.
  • Correlation Between Baseline Homocysteine Levels and Smoking Status [ Time Frame: Baseline ]
    Baseline blood homocysteine lab levels are reported by smoking status.
  • Correlation Between Baseline Blood B12 Levels and MTHFR Genotype [ Time Frame: Baseline ]
    Baseline blood B12 lab levels are reported by MTHFR genotype.
  • Correlation Between Baseline Blood Homocysteine Levels and MTHFR Genotype [ Time Frame: Baseline ]
    Baseline blood homocysteine lab levels are reported by MTHFR genotype.
  • Correlation Between Baseline Serum B12 Levels and Dietary Intake [ Time Frame: Baseline ]
    Baseline serum B12 lab levels and dietary intake levels are reported.
  • Correlation Between Baseline Blood Homocysteine Levels and Dietary Intake [ Time Frame: Baseline ]
    Baseline blood homocysteine lab levels and dietary intake levels are reported.
  • Correlation Between Baseline Blood Folate or B12 Levels and Dietary Intake [ Time Frame: Baseline ]
    Baseline blood folate and B12 lab levels and dietary intake levels are reported.
Not Provided
Complete list of historical versions of study NCT00249288 on ClinicalTrials.gov Archive Site
  • Correlations Between Baseline Blood Folate and Clinical Ratings of Negative Symptoms by Comparing Lab Levels in Deficit Syndrome Versus Non-deficit Syndrome Patients [ Time Frame: Baseline ]
    Baseline blood folate lab levels are reported by deficit syndrome status.
  • Correlations Between Baseline Blood B12 Levels and Clinical Ratings of Negative Symptoms by Comparing Lab Levels in Deficit Syndrome Versus Non-deficit Syndrome Patients [ Time Frame: Baseline ]
    Baseline blood B12 lab levels are reported by deficit syndrome status.
  • Correlations Between Baseline Blood Homocysteine Levels and Clinical Ratings of Negative Symptoms by Comparing Lab Levels in Deficit Syndrome Versus Non-deficit Syndrome Patients [ Time Frame: Baseline ]
    Baseline blood homocysteine lab levels are reported by deficit syndrome status.
Not Provided
Not Provided
Not Provided
 
Folate Supplementation in Schizophrenia
Folate Supplementation in Schizophrenia
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.

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
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • Drug: Folate
    Folic acid taken as 2, 1mg capsule daily for 12 weeks
    Other Name: Folate or folic acid
  • Drug: Placebo
    Placebo taken as 2, 1mg capsule daily for 12 weeks
  • Experimental: Folate
    Participants will receive a 2 mg/ day dose of folate, for 12 weeks
    Intervention: Drug: Folate
  • Placebo Comparator: Placebo
    Participants will receive a 2 mg/ day dose of placebo, for 12 weeks
    Intervention: Drug: Placebo
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. doi: 10.1016/j.schres.2010.12.006. Epub 2011 Feb 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
50
June 2008
June 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 68 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00249288
2004P-000495
No
Not Provided
Not Provided
Donald C. Goff, MD, Massachusetts General Hospital
Massachusetts General Hospital
National Alliance for Research on Schizophrenia and Depression
Principal Investigator: Donald C. Goff, M.D. Massachusetts General Hospital
Massachusetts General Hospital
March 2018

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