Phase 4
Completed N=140
Effectiveness of Vitamin Supplementation in Treating People With Residual Symptoms of Schizophrenia
Source: ClinicalTrials.gov NCT00611806 ↗Enrolled (actual)
140
Serious AEs
5.7%
Results posted
Aug 2014
Primary outcomePrimary: Positive and Negative Syndrome Scale (PANSS) — -.21; -.22 units on a scale
Summary
This study will evaluate the effectiveness of folate and B12 supplementation in reducing negative symptoms in people with schizophrenia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Positive and Negative Syndrome Scale (PANSS) |
-.21; -.22 | — |
| SECONDARY Cognitive Deficits, as Measured by the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Cognitive Battery Composite Score |
— | — |
| SECONDARY Positive Sub Scale of the Positive and Negative Syndrome Scale (PANSS) |
-.06; -.04 | — |
| SECONDARY Scale for Assessment of Negative Symptoms (SANS) |
-.19; .02 | — |
| SECONDARY Positive and Negative Syndrome Scale (PANSS) and FOLH1, MTHRF, MTR, and COMT Genotype |
-.21; -.1 | — |
| SECONDARY Relationship Between Response of Negative and Positive Symptoms and the Change in RBC Folate, Serum Folate, Serum B12, and Plasma Homocysteine Concentrations |
— | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00611806). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.