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

Completed · Phase 4 · Has a placebo group

Conditions studied: Schizophrenia

In brief

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

Key facts

Study ID

NCT00611806

Run by

Massachusetts General Hospital

People needed

140

Starts

2007-12-01

Expected to finish

2010-12-01

Last updated by the study team

2014-08-19

Who can join

Age: 18 and older, up to 68. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Massachusetts General Hospital Schizophrenia Program - Freedom Trail Clinic — Boston, Massachusetts, United States
• Touchstone innovare — Grand Rapids, Michigan, United States
• URMC Severe Mental Disorders Program — Rochester, New York, United States

Full record on ClinicalTrials.gov

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