| Home | Search | Study Topics | Glossary |
|
|
|
 |
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Descriptive Information Fields | |||||||||
| Brief Title † | Effectiveness of Vitamin Supplementation in Treating People With Residual Symptoms of Schizophrenia | ||||||||
| Official Title † | A Placebo-Controlled Trial of Folate With B12 in Schizophrenia Patients With Residual Symptoms | ||||||||
| Brief Summary | This study will evaluate the effectiveness of folate and B12 supplementation in reducing negative symptoms in people with schizophrenia. |
||||||||
| 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. |
||||||||
| Study Phase | Phase IV | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | 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 Measure † | 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 ] |
||||||||
| Condition † | Schizophrenia | ||||||||
| Intervention † | Dietary Supplement: Folic acid with B12 Drug: Placebo |
||||||||
| MEDLINE PMIDs | |||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 144 | ||||||||
| Start Date † | December 2007 | ||||||||
| Completion Date | December 2010 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years to 68 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
|
||||||||
| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00611806 | ||||||||
| Organization ID | R01 MH070831 | ||||||||
| Secondary IDs †† | DATR A5-ETPD | ||||||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
|
||||||||
| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | August 2008 | ||||||||
| First Received Date † | February 7, 2008 | ||||||||
| Last Updated Date | August 20, 2008 | ||||||||
|
