drugset / Trial / NCT01514682

Anti-Inflammatory Treatment of Schizophrenia

NCT01514682

Completed 50 enrolled University of Maryland, Baltimore
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2012-06
Primary completion
2017-04-17
Completion
2017-04-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluvastatin Other / unclassified 40 mg
Subject Salsalate Small molecule 4 g
Subject docosahexaenoic Other / unclassified 2 g
Subject eicosapentaenoic Other / unclassified 2 g

Indications