Salsalate as an Adjunctive Treatment for Patients With Schizophrenia

The specific aims include:

Primary aims:

• Examine the efficacy of salsalate (3g/day) in improving positive and negative symptoms as measured by the Positive and Negative Syndrome Scale (PANSS) and the Scale for Assessment of Negative Symptoms (SANS).
• Examine the efficacy of salsalate in improving cognition as measured by the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) composite score.

Secondary aims:

• Examine salsalate's effects on inflammatory markers such as high sensitivity C-reactive protein (hs-CRP), TNF-α and IL-6.

Inclusion criteria

• Age 18-65 years;
• Diagnosis of schizophrenia or schizoaffective disorder;
• Stable dose of the current antipsychotic drug for at least one month;
• Well established compliance with outpatient treatment per treating clinician's judgment;
• Able to complete the cognitive assessment battery (must be English speaking);
• Female subjects will be eligible to participate in the study if they are of non-childbearing potential or of child-bearing potential and willing to practice appropriate birth control methods during the study.

Exclusion criteria

• Inability to provide informed consent;
• Current substance abuse;
• Psychiatrically unstable per treating clinician's judgment;
• Significant medical illnesses including uncontrolled hypertension, diabetes, seizure disorder, severe cardiovascular, cerebrovascular, pulmonary, or thyroid diseases;
• Currently on immunosuppressant medication including oral steroids;
• Use of anti-coagulants (heparin, LMWH, warfarin, cilostazol, clopidogrel, dabigatran);
• History of chronic infection (including, HIV and hepatitis), malignancy, organ transplantation, blood dyscrasia, central nervous system demyelinating disorder, and any other known autoimmune or inflammatory condition;
• Experienced asthma, urticaria or allergic type reaction after taking aspirin, salsalate, or other NSAIDS;
• Pregnancy or breastfeeding;
• Pre-existing chronic tinnitus.
• Known hypersensitivity to salsalate.