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Completed

NCT Number: NCT00249288

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Folate

Drug

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

Other names: Folate or folic acid

Placebo

Drug

Placebo taken as 2, 1mg capsule daily for 12 weeks

Primary outcomes

  1. Correlation Between Baseline Blood Folate and Smoking Status

    Time frame: Baseline

    Baseline blood folate lab levels are reported by smoking status.

  2. Correlation Between Baseline Blood Folate and MTHFR Genotype

    Time frame: Baseline

    Baseline blood folate lab levels are reported by MTHFR genotype.

  3. Correlation Between Baseline Blood Folate Levels and Dietary Intake

    Time frame: Baseline

    Baseline blood folate lab levels and dietary intake levels are reported.

  4. 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.

  5. Correlation Between Baseline Serum B12 Levels and Smoking Status

    Time frame: Baseline

    Baseline serum B12 lab levels are reported by smoking status.

  6. Correlation Between Baseline Homocysteine Levels and Smoking Status

    Time frame: Baseline

    Baseline blood homocysteine lab levels are reported by smoking status.

  7. Correlation Between Baseline Blood B12 Levels and MTHFR Genotype

    Time frame: Baseline

    Baseline blood B12 lab levels are reported by MTHFR genotype.

  8. Correlation Between Baseline Blood Homocysteine Levels and MTHFR Genotype

    Time frame: Baseline

    Baseline blood homocysteine lab levels are reported by MTHFR genotype.

  9. Correlation Between Baseline Serum B12 Levels and Dietary Intake

    Time frame: Baseline

    Baseline serum B12 lab levels and dietary intake levels are reported.

  10. Correlation Between Baseline Blood Homocysteine Levels and Dietary Intake

    Time frame: Baseline

    Baseline blood homocysteine lab levels and dietary intake levels are reported.

  11. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Alliance for Research on Schizophrenia and Depression

Registry information

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Nov 7, 2005
Registry last updated
Apr 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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