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Folate Supplementation in Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Donald C. Goff, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00249288
First received: November 3, 2005
Last updated: July 14, 2014
Last verified: July 2014
  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
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Folate Supplementation in Schizophrenia

Resource links provided by NLM:


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 ]
  • Efficacy of Folate Supplementation for Reducing Negative Symptoms as Measured by the SANS [ Time Frame: Baseline score vs. week 12 score ] [ Designated as safety issue: No ]
    The change from baseline to week 12 on the scale for the assessment of negative symptoms (SANS) 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).


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 ]

Enrollment: 46
Study Start Date: December 2003
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
Publications:
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
Study First Received: November 3, 2005
Results First Received: June 11, 2014
Last Updated: July 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Schizophrenia
Negative Symptoms
Folate

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Folic Acid
Vitamin B Complex
Growth Substances
Hematinics
Hematologic Agents
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vitamins

ClinicalTrials.gov processed this record on November 25, 2014