Status:
COMPLETED
Effectiveness of Vitamin Supplementation in Treating People With Residual Symptoms of Schizophrenia
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Schizophrenia
Eligibility:
All Genders
18-68 years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00611806
Start Date
December 1 2007
End Date
December 1 2010
Last Update
August 19 2014
Active Locations (3)
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1
Massachusetts General Hospital Schizophrenia Program - Freedom Trail Clinic
Boston, Massachusetts, United States, 02114
2
Touchstone innovare
Grand Rapids, Michigan, United States, 49503
3
URMC Severe Mental Disorders Program
Rochester, New York, United States, 14623