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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01578486
Other study ID # 2011-P-000798
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


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
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