Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
National Institute of Mental Health (NIMH) |
---|---|
Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00611806 |
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 with B12 Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Placebo-Controlled Trial of Folate With B12 in Schizophrenia Patients With Residual Symptoms |
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 |
---|---|
1: Experimental
Participants will take folic acid plus B12 for 18 weeks.
|
Dietary Supplement: Folic acid with B12
2-mg capsule of folic acid with 400 micrograms of B12 once daily
Drug: Placebo
Placebo capsule once daily
|
2: Placebo Comparator
Participants will take placebo for 18 weeks.
|
Drug: Placebo
Placebo capsule once daily
|
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.
Ages Eligible for Study: | 18 Years to 68 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lisa Raeke, MA | 617-912-7840 | lraeke@partners.org |
Contact: Hope McChesney, BA | 617-912-7845 | hmcchesney@partners.org |
United States, Massachusetts | |
Massachusetts General Hospital Schizophrenia Program - Freedom Trail Clinic | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Hope McChesney 617-912-7845 hmcchesney@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 |
Principal Investigator: | Donald Goff, MD | Massachusetts General Hospital |
Responsible Party: | Massachusetts General Hospital ( Donald Goff, MD ) |
Study ID Numbers: | R01 MH070831, DATR A5-ETPD |
Study First Received: | February 7, 2008 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00611806 |
Health Authority: | United States: Federal Government |
Cognition Folic Acid B12 |
Folic Acid Schizophrenia Mental Disorders Hydroxocobalamin |
Vitamin B 12 Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |
Vitamin B Complex Hematinics Therapeutic Uses Growth Substances Vitamins |
Hematologic Agents Physiological Effects of Drugs Micronutrients Pharmacologic Actions |