Salsalate as an Adjunctive Treatment for Patients With Schizophrenia

NCT ID: NCT01578486

Last Updated: 2018-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2015-07-31

Brief Summary

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.

Detailed Description

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

salsalate

open-label trial of salsalate 3g/day

Group Type: EXPERIMENTAL

salsalate

Intervention Type: DRUG

open-label trial of salsalate 3g/day for 12 weeks.

Interventions

salsalate

open-label trial of salsalate 3g/day for 12 weeks.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role: lead

Responsible Party

Xiaoduo Fan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaoduo Fan, MD, MPH, MS

Role: PRINCIPAL_INVESTIGATOR

UMass Medical School

Matthew R Goodnow, BS

Role: STUDY_DIRECTOR

UMass Medical School

Locations

University of Massaschusetts Medical School

Worcester, Massachusetts, United States

Countries

United States

Other Identifiers

2011-P-000798

Identifier Type: -

Identifier Source: org_study_id