Salsalate as an Adjunctive Treatment for Patients With Schizophrenia

Completed · Phase 4

Conditions studied: Schizophrenia, Schizoaffective Disorder

In brief

This is a 12-week, open-label trial of salsalate 3 g/day as an adjunctive treatment in 15 schizophrenia subjects to examine salsalate's effect on psychopathology, cognitive functioning, and metabolic parameters. Potential subjects will be identified by their clinicians at the Freedom Trail Clinic, or Massachusetts General Hospital. A total of 15 subjects will be enrolled.

Key facts

Study ID

NCT01578486

Run by

University of Massachusetts, Worcester

People needed

17

Starts

2011-06-01

Expected to finish

2015-07-01

Last updated by the study team

2018-05-08

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Massaschusetts Medical School — Worcester, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.