Salsalate as an Adjunctive Treatment for Patients With Schizophrenia

The specific aims include:

Primary aims:

1. 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).

2. 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:

1. 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.