Abstract
BackgroundNegative symptoms and cognitive deficits are two partially-related features of schizophrenia which have a major negative impact on social function and objective quality of life. Standard drug treatments have little impact on either. There is some evidence that anti-inflammatory treatment may have beneficial effects in schizophrenia and major depression. Statins are cholesterol-lowering agents that have been found to be anti-inflammatory agents and are also known to decrease C-reactive protein (CRP). Ondansetron is a serotonin (5-HT3) receptor antagonist widely used to prevent nausea and vomiting in patients receiving chemotherapy for cancer. Small studies have suggested that ondansetron is effective as an adjunct drug in improving the symptoms of schizophrenia.Methods/designThis is a two center, six-month, double-blind placebo controlled, factorial design study of ondansetron and/or simvastatin added to treatment as usual for patients suffering from schizophrenia, schizoaffective disorder, psychosis not otherwise specified or schizophreniform disorder. This will be a 2 × 2 design, with 54 patients in each cell, giving a total of 216 patients over three years. There will be a screening, a randomization and seven follow-up visits. Full clinical and neurocognitive assessments will be carried out at baseline (randomization), 14 weeks and at 26 weeks, while the positive and negative syndrome scale (PANSS), pill count and side effects checklist will be carried out at every visit. Simvastatin will be started at 20 mg once daily (OD), this will be increased to 40 mg after four weeks. Ondansetron will be administered in an 8 mg dose.DiscussionAnti-inflammatory treatments have been shown to have some beneficial effects in schizophrenia. Both simvastatin and ondansetron provide some evidence of a reduction in symptoms compared to treatment as usual. The aim of this study is to establish the degree of improvement in negative symptoms with the addition of ondansetron and/or simvastatin to treatment as usual.Trail registrationClinicalTrails.gov NCT01602029
Highlights
Negative symptoms and cognitive deficits are two partially-related features of schizophrenia which have a major negative impact on social function and objective quality of life
Anti-inflammatory treatments have been shown to have some beneficial effects in schizophrenia
Both simvastatin and ondansetron provide some evidence of a reduction in symptoms compared to treatment as usual
Summary
Schizophrenia is characterized by disorder of thought, perception, volition, socialization and psychomotor behavior. Antiinflammatory treatments have been shown to have some beneficial effects in schizophrenia Both simvastatin and ondansetron provide some evidence of a reduction in symptoms compared to treatment as usual. The preliminary feasibility study adding ondansetron or simvastatin to TAU in patients with chronic schizophrenia (ClinicalTrails.gov NCT00929955) showed both treatments were well tolerated and no serious side effects were reported. Findings are from this randomized controlled trial of simvastatin and ondansetron added to TAU may contribute to evidence in the management of negative symptoms and cognitive deficits in patients with schizophrenia. JH, MMH, RR and AK are contributing to recruitment of the patients and, with TK and NH, are doing the assessments.
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