Effectiveness of Vitamin Supplementation in Treating People With Residual Symptoms of Schizophrenia

NCT00611806 | Completed Phase 4 Results DMC

• 2 other identifiers: R01MH070831DATR A5-ETPD
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 3

Brief Summary

This study will evaluate the effectiveness of folate and B12 supplementation in reducing negative symptoms in people with schizophrenia.

Conditions

Schizophrenia

Keywords

Cognition; Folic Acid; B12

Outcome Measures

Primary Outcomes (1)

• Positive and Negative Syndrome Scale (PANSS)

  The change from baseline on the Positive and Negative Syndrome Scale (PANSS).The PANNS has three subscales: positive (score range 7-49), negative (score range 7-49), and general psychopathology (score range 16-112). The PANSS positive symptom sub-scale is comprised of 7 items rated on a scale of 1-7, representing positive symptoms of schizophrenia. The PANSS negative symptom subscale is comprised of 7 items rated on a scale of 1-7 representing the negative symptoms of schizophrenia, and the general psychopathology subscale is comprised of 16 items rated on a scale of 1-7 representing symptoms of general psychopathology in mental illness. The total score was computed by adding all the items on the sub-scale together. Scores reported are change in symptoms per week, relative to baseline. A negative score represents a decrease in total PANSS score per week, whereas a positive score represents an increase in total PANSS score per week.

  Baseline vs. Week 16

Secondary Outcomes (5)

• Cognitive Deficits, as Measured by the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Cognitive Battery Composite Score

  Measured at Week 16

• Positive Sub Scale of the Positive and Negative Syndrome Scale (PANSS)

  Baseline vs. Week 16

• Scale for Assessment of Negative Symptoms (SANS)

  Baseline vs. Week 16

• Positive and Negative Syndrome Scale (PANSS) and FOLH1, MTHRF, MTR, and COMT Genotype

  Baseline vs. Week 16

• Relationship Between Response of Negative and Positive Symptoms and the Change in RBC Folate, Serum Folate, Serum B12, and Plasma Homocysteine Concentrations

  Measured at Week 16

Study Arms (2)

Folate with B12

ACTIVE COMPARATOR

Participants will take folic acid plus B12 for 18 weeks.

Dietary Supplement: Folic Acid; Dietary Supplement: B12

Placebo

PLACEBO COMPARATOR

Participants will take placebo for 18 weeks.

Other: Placebo

Interventions

Folic Acid DIETARY_SUPPLEMENT

Folic acid 2mg po daily

Folate with B12

B12 DIETARY_SUPPLEMENT

B12 400 micrograms po daily

Also known as: cobalamin

Folate with B12

Placebo OTHER

1 capsule po daily

Placebo

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of schizophrenia, any subtype
• Treated with an antipsychotic medication for at least 6 months at a stable dose for at least 6 weeks before study entry
• PANSS total score of at least 60, with a score of at least 3 (moderate) on one negative symptom item or on one positive symptom item
• Simpson Angus Scale (SAS) for Extrapyramidal Syndrome (EPS) total score of 12 or less
• A score of 2 (mild) or less on all items of the Calgary Depression Scale (CDS)
• Speaks English adequately enough to complete cognitive testing

You may not qualify if:

• Serum B12 concentration less than 300 ug/L
• Complete blood count results consistent with megaloblastic anemia
• Serum creatinine concentration greater than 1.4
• Current use of folate or B12 supplementation
• Current use of any of the following medications: phenobarbital, phenytoin, carbamazepine, valproic acid, fosphenytoin, primidone, or pyrimethamine
• Alcohol or other substance abuse within 3 months before study entry (nicotine allowed)
• Positive baseline urine toxic screen
• Unstable medical illness
• Unstable psychiatric illness
• Seizure disorder
• Pregnant or breastfeeding

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (3)

Massachusetts General Hospital Schizophrenia Program - Freedom Trail Clinic

Boston, Massachusetts, 02114, United States

Location

Touchstone innovare

Grand Rapids, Michigan, 49503, United States

Location

URMC Severe Mental Disorders Program

Rochester, New York, 14623, United States

Location

Related Publications (1)

• Roffman JL, Lamberti JS, Achtyes E, Macklin EA, Galendez GC, Raeke LH, Silverstein NJ, Smoller JW, Hill M, Goff DC. Randomized multicenter investigation of folate plus vitamin B12 supplementation in schizophrenia. JAMA Psychiatry. 2013 May;70(5):481-9. doi: 10.1001/jamapsychiatry.2013.900.

  PMID: 23467813 RESULT

MeSH Terms

Conditions

Schizophrenia

Interventions

Folic Acid; Vitamin B 12

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds, 4 or More Rings; Macrocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Joshua L. Roffman, MD
• Organization: Massachusetts General Hospital

jroffman@partners.org

617-724-1920

Study Officials

• Donald Goff, MD

  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: February 7, 2008
• First Posted: February 11, 2008
• Study Start: December 1, 2007
• Primary Completion: August 1, 2010
• Study Completion: December 1, 2010
• Last Updated: August 19, 2014
• Results First Posted: August 19, 2014

Record last verified: 2014-07

Locations

US (3)