At a glance
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Anti-Inflammatory Combination Therapy for the Treatment of Schizophrenia
In Brief
A clinical study evaluating Anti-inflammatory Combination Therapy and Placebo for Schizophrenia. Completed, enrolled 50 participants across 1 site.
Detailed Summary
Despite current antipsychotic treatment, the majority of people with schizophrenia continue to exhibit persistent positive and negative symptoms and cognitive impairments. An alternative approach to the use of psychotropic agents for the treatment of persistent symptoms is the use of anti-inflammatory agents to reverse the pro-inflammatory state hypothesized to underlie the symptom and sign manifestations of the illness. The investigators primary hypothesis is that add-on anti-inflammatory combination therapy will have significant beneficial effects on persistent positive symptoms and cognitive impairments. The investigators secondary hypotheses are: 1. add-on anti-inflammatory combination therapy will be associated with improvements in depressive and negative symptoms and a reduction in pro-inflammatory cytokines 2. add-on anti-inflammatory combination therapy compared to placebo will not be associated with elevated adverse risk.
Study Details
Timeline
Interventions
1. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening 2. fluvastatin: target dose 40 mg/day, administered in a single evening dose 3. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose
Non-medication pills; To be taken in morning and evening intervals.