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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by National Institute of Mental Health (NIMH).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00611806
First received: February 7, 2008
Last updated: December 31, 2009
Last verified: December 2009
  Purpose

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


Condition Intervention Phase
Schizophrenia
Dietary Supplement: Folic Acid
Dietary Supplement: B12
Other: 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: A Placebo-Controlled Trial of Folate With B12 in Schizophrenia Patients With Residual Symptoms

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Reduction in schizophrenia symptoms, as measured by the change from baseline in Positive and Negative Syndrome Scale (PANSS) total score [ Time Frame: Measured at Week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cognitive deficits, as measured by the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) cognitive battery composite score [ Time Frame: Measured at Week 16 ] [ Designated as safety issue: No ]
  • Psychotic symptoms, as measured by the PANSS psychosis subscale score [ Time Frame: Measured at Week 16 ] [ Designated as safety issue: No ]
  • Negative symptoms, as measured by the modified Scale for Assessment of Negative Symptoms (SANS) total score [ Time Frame: Measured at Week 16 ] [ Designated as safety issue: No ]
  • Relationship among PANSS total score; negative and positive symptoms; cognitive performance; baseline serum and red blood cell (RBC) folate, plasma homocysteine, and B12 concentrations; tobacco intake; and MTHFR C677T gene status [ Time Frame: Measured at Week 16 ] [ Designated as safety issue: No ]
  • Relationship between response of negative and positive symptoms and the change in RBC folate, serum folate, serum B12, and plasma homocysteine concentrations [ Time Frame: Measured at Week 16 ] [ Designated as safety issue: No ]

Estimated Enrollment: 144
Study Start Date: December 2007
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Folate with B12
Participants will take folic acid plus B12 for 18 weeks.
Dietary Supplement: Folic Acid
Folic acid 2mg po daily
Dietary Supplement: B12
B12 400 micrograms po daily
Other Name: cobalamin
Placebo Comparator: Placebo
Participants will take placebo for 18 weeks.
Other: Placebo
1 capsule po daily

Detailed Description:

About 30% of people with schizophrenia suffer from treatment-resistant psychotic symptoms, which may include social withdrawal, apathy, and depression. These negative symptoms can produce substantial distress for those affected, often disrupting social and occupational functioning and resulting in hospitalization. Although atypical antipsychotic medications have demonstrated some success in treating negative symptoms, the degree to which many negative symptoms respond is unclear. Depression and poor response to antidepressant medication have been linked to deficiency in the vitamins folate and B12. It is believed that vitamin supplementation with folate and B12 may offer a safe and inexpensive approach to improve outcomes for people with schizophrenia who have residual negative symptoms and have exhibited poor treatment response. This study will compare the effectiveness of folate and B12 versus placebo in reducing negative symptoms in people with schizophrenia.

Participation in this double-blind study will last 19 weeks. Potential participants will undergo initial screening, which will include a medical and psychiatric evaluation, physical exam, blood draw, urine sampling, and questionnaires. Participants will also be asked for permission to use a portion of the blood sample for genetic analysis. Eligible participants will be randomly assigned to take folate with B12 or placebo. Participants will first complete a 2-week stabilization phase, followed by the 16-week treatment study. Medication visits, occurring every 2 weeks during treatment, will include questions about medication side effects and the distribution of study medication. During specified medication visits, participants will complete various assessments, which will include questionnaires about schizophrenia, tests of learning and memory, repeat blood tests, and pregnancy tests. The medication visits will last between 15 minutes and 4 hours, depending on the scheduled assessments for that visit.

  Eligibility

Ages Eligible for Study:   18 Years to 68 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00611806

Contacts
Contact: Lisa Raeke, MA 617-912-7840 lraeke@partners.org
Contact: Gail Galendez, BA 617-912-7845 ggalendez@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Schizophrenia Program - Freedom Trail Clinic Recruiting
Boston, Massachusetts, United States, 02114
Contact: Gail Galendez    617-912-7845    ggalendez@partners.org   
Contact: Meghan Shanahan    617-912-7842    meshanahan@partners.org   
Principal Investigator: Donald Goff, MD         
United States, Michigan
Touchstone innovare Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Heather Willett    616-459-4212 ext 315    heather.willett@TI-GR.com   
Principal Investigator: Eric Achtyes, MD         
United States, New York
URMC Severe Mental Disorders Program Recruiting
Rochester, New York, United States, 14623
Contact: Ellen Raisbeck    585-279-4917    Ellen_Raisbeck@URMC.Rochester.edu   
Principal Investigator: J. Stephen Lamberti, MD         
Sponsors and Collaborators
Investigators
Principal Investigator: Donald Goff, MD Massachusetts General Hospital
  More Information

No publications provided by National Institute of Mental Health (NIMH)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Donald Goff, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00611806     History of Changes
Other Study ID Numbers: R01 MH070831, DATR A5-ETPD
Study First Received: February 7, 2008
Last Updated: December 31, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Cognition
Folic Acid
B12

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

ClinicalTrials.gov processed this record on April 22, 2014