NCT00249288

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for phase_4 schizophrenia

Timeline
Completed

Started Dec 2003

Longer than P75 for phase_4 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 7, 2005

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
6.2 years until next milestone

Results Posted

Study results publicly available

August 6, 2014

Completed
Last Updated

April 5, 2018

Status Verified

March 1, 2018

Enrollment Period

4.5 years

First QC Date

November 3, 2005

Results QC Date

June 11, 2014

Last Update Submit

March 9, 2018

Conditions

Schizophrenia

Keywords

SchizophreniaNegative SymptomsFolate

Outcome Measures

Primary Outcomes (11)

  • Correlation Between Baseline Blood Folate and Smoking Status

    Baseline blood folate lab levels are reported by smoking status.

    Baseline

  • Correlation Between Baseline Blood Folate and MTHFR Genotype

    Baseline blood folate lab levels are reported by MTHFR genotype.

    Baseline

  • Correlation Between Baseline Blood Folate Levels and Dietary Intake

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

    Baseline

  • Efficacy of Folate Supplementation for Reducing Negative Symptoms as Measured by the SANS Modified Total

    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.

    Baseline score vs. week 12 score

  • Correlation Between Baseline Serum B12 Levels and Smoking Status

    Baseline serum B12 lab levels are reported by smoking status.

    Baseline

  • Correlation Between Baseline Homocysteine Levels and Smoking Status

    Baseline blood homocysteine lab levels are reported by smoking status.

    Baseline

  • Correlation Between Baseline Blood B12 Levels and MTHFR Genotype

    Baseline blood B12 lab levels are reported by MTHFR genotype.

    Baseline

  • Correlation Between Baseline Blood Homocysteine Levels and MTHFR Genotype

    Baseline blood homocysteine lab levels are reported by MTHFR genotype.

    Baseline

  • Correlation Between Baseline Serum B12 Levels and Dietary Intake

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

    Baseline

  • Correlation Between Baseline Blood Homocysteine Levels and Dietary Intake

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

    Baseline

  • Correlation Between Baseline Blood Folate or B12 Levels and Dietary Intake

    Baseline blood folate and B12 lab levels and dietary intake levels are reported.

    Baseline

Secondary Outcomes (3)

  • Correlations Between Baseline Blood Folate and Clinical Ratings of Negative Symptoms by Comparing Lab Levels in Deficit Syndrome Versus Non-deficit Syndrome Patients

    Baseline

  • Correlations Between Baseline Blood B12 Levels and Clinical Ratings of Negative Symptoms by Comparing Lab Levels in Deficit Syndrome Versus Non-deficit Syndrome Patients

    Baseline

  • Correlations Between Baseline Blood Homocysteine Levels and Clinical Ratings of Negative Symptoms by Comparing Lab Levels in Deficit Syndrome Versus Non-deficit Syndrome Patients

    Baseline

Study Arms (2)

Folate

EXPERIMENTAL

Participants will receive a 2 mg/ day dose of folate, for 12 weeks

Drug: Folate

Placebo

PLACEBO COMPARATOR

Participants will receive a 2 mg/ day dose of placebo, for 12 weeks

Drug: Placebo

Interventions

FolateDRUG

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

Also known as: Folate or folic acid
Folate
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years - 68 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Unstable medical illness
  • Substance abuse
  • Megaloblastic anemia
  • Non-english speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • 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.

    PMID: 21334854RESULT

MeSH Terms

Conditions

Schizophrenia

Interventions

Folic Acid

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Michelle Hill
Organization
Schizophrenia Program, Massachusetts General Hospital
michelehill1@gmail.com
617-912-7846

Study Officials

  • Donald C. Goff, M.D.

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Schizophrenia Clinical and Research Program

Study Record Dates

First Submitted

November 3, 2005

First Posted

November 7, 2005

Study Start

December 1, 2003

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

April 5, 2018

Results First Posted

August 6, 2014

Record last verified: 2018-03

Locations

US(1)