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Folate Supplementation in Schizophrenia

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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

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Folate Drug: Placebo Phase 4

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 : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Folate Supplementation in Schizophrenia
Study Start Date : December 2003
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Folate
Participants will receive a 2 mg/ day dose of folate, for 12 weeks
Drug: Folate
Folic acid taken as 2, 1mg capsule daily for 12 weeks
Other Name: Folate or folic acid

Placebo Comparator: Placebo
Participants will receive a 2 mg/ day dose of placebo, for 12 weeks
Drug: Placebo
Placebo taken as 2, 1mg capsule daily for 12 weeks




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 68 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications of Results:
Responsible Party: Donald C. Goff, MD, Director of the Schizophrenia Clinical and Research Program, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00249288     History of Changes
Other Study ID Numbers: 2004P-000495
First Posted: November 7, 2005    Key Record Dates
Results First Posted: August 6, 2014
Last Update Posted: April 5, 2018
Last Verified: March 2018

Keywords provided by Donald C. Goff, MD, Massachusetts General Hospital:
Schizophrenia
Negative Symptoms
Folate

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Folic Acid
Vitamin B Complex
Hematinics
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs