Anti-Inflammatory Treatment of Schizophrenia

• Status: Completed
• Trial end date: 2017-04-17
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Maryland; University of Maryland, Baltimore
• Treatments: Anti-Inflammatory Agents; Salicylsalicylic acid

Criteria

Inclusion Criteria:

• Participants will meet DSM-IV-TR criteria for schizophrenia or schizoaffective disorder.

• Participants will be required to meet the following symptom criteria:

1. BPRS total score of 45 or greater on the 18 item version (scale: 1-7) or a Clinical Global Impression (CGI) severity of illness item score of 4 (moderate) or greater.

2. BPRS positive symptom item total score of 8 or greater and a score of 4 or more on at least one individual item.

• Participants will be clinically stable, be treated with the same antipsychotic for at least 60 days and a constant therapeutic dose for at least 30 days prior to study entry.

• Participants must be judged competent to participate in the informed consent process and provide voluntary informed consent

Exclusion Criteria:

• Participants who meet DSM-IV-TR criteria for alcohol or substance dependence (except nicotine) within the last 6 months or DSM-IV-TR criteria for alcohol or substance abuse (except nicotine) within the last month will be excluded

• Participants with a current infection or an organic brain disorder or medical condition, whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol will be excluded.

• Participants with a history of: aspirin allergy, pre-existing tinnitus, tuberculosis, HIV, or hepatitis C; or autoimmune disease.

• Participants who are currently treated with a statin, warfarin, dipyridamole, or other anti-coagulants.

• Participant is currently treated with an omega-3-fatty acid preparation and cannot discontinue their use of the preparation for the duration of the study.

• Female participant who is sexually active and not using any form of birth control such as oral contraceptives or IUDs.

• Female participant who is pregnant or breastfeeding.

• Participant with current/active peptic ulcer disease or gastritis; anemia or thrombocytopenia (platelet count ≤120).

• Participant who is currently treated with a medication that can increase the risk of myopathy and rhabdomyolysis such as Fluconazole, Ketoconazole, Colchicine, Daptomycin, Erythromycin, or immunosuppressants that alter statin levels.