Salsalate as an Adjunctive Treatment for Patients With Schizophrenia

Schizophrenia Clinical Trial

Official title:

Salsalate as an Adjunctive Treatment for Patients With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01578486
• Other study ID #: 2011-P-000798
• Status: Completed
• Phase: Phase 4
• Start date: June 2011
• Est. completion date: July 2015

Study information

• Verified date: April 2018
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

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

Locations

Country	Name	City	State
United States	University of Massaschusetts Medical School	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PANSS Total Score	Positive and negative symptoms of schizophrenia will be measured by total score on all subscales of the Positive and Negative Syndrome Scale (PANSS; score range 30-210). Higher scores correspond with worse outcomes.	Baseline and 12 weeks
Primary	SANS Total Score	Negative symptoms of schizophrenia will be measured by total score on the Scale for Assessment of Negative Symptoms (SANS; score range 0-100). Higher scores correspond with worse outcomes.	Baseline, 12 weeks
Primary	MATRICS Composite Score	Improved cognition will be measured using the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) assessment. The MATRICS assessment includes a battery of tests, and the composite t-score measures cognition across 7 domains including speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. A higher score indicates better cognition.	Baseline, 12 weeks
Primary	PANSS Positive Score	Subscale of Positive and Negative Syndrome Scale that specifically measures positive symptoms. The scores range from 7-49, with higher scores representing a worse outcome.	Baseline, 12 weeks
Primary	PANSS- Negative Score	Subscale of Positive and Negative Syndrome Scale that specifically measures negative symptoms. The scores range from 7-49, with higher scores representing a worse outcome.	Baseline, 12 weeks
Secondary	Hs-CRP	High-sensitivity C-reactive protein (hs-CRP) will be measured in mg/L in order to detect inflammation. Higher hs-CRP values correspond to higher levels of inflammation.	Baseline, 12 weeks
Secondary	TNF-alpha	Tumor necrosis-alpha factor will be measured to assess inflammation levels.	Baseline,12 weeks
Secondary	IL-6	IL-6 (interleukin 6) is a marker used to measure inflammation.	Baseline, week 12